The HAPTITE Coating Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
Device Story
HAPTITE Coating Implant System consists of endosseous root-form dental implants and associated abutments. Implants are manufactured from Grade 4 Titanium (ASTM F67). The surface features a Super High Speed (SHS) Hydroxyapatite (HA) coating applied at room temperature via a high-speed particle impact process (carrier gas/nitrogen, vacuum chamber, spray nozzle). This process creates a thin (1-2µm) crystalline HA film to reduce bone loss. The system includes i-clean (non-submerged) and s-clean (submerged) fixture types with various diameters and lengths. Used by dental clinicians in surgical settings for prosthetic tooth replacement. The device provides a stable foundation for dental prosthetics, facilitating osseointegration and long-term prosthetic support.
Clinical Evidence
Bench testing only. Testing included shear bonding strength (~37 MPa) and tensile bonding strength (~41 MPa) per ASTM F1147/F1044, exceeding the 34.5 MPa standard. Additional bench evaluations included gap measurement, rotational angle tests, and surface characterization (roughness, crystallinity, porosity, CaP ratio). An animal study (pig bone) was conducted to evaluate HA coating stability.
Technological Characteristics
Materials: Grade 4 Titanium (ASTM F67). Surface: HA coating (1-2µm thickness, 100% crystalline). Coating process: Super High Speed (SHS) Blast Coating. Fixture types: i-clean (non-submerged, 8° connection) and s-clean (submerged, 11° connection). Sterilization: Gamma radiation. Connectivity: None (mechanical device).
Indications for Use
Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Not indicated for immediate loading; intended for delayed loading.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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K111364
# 510(K) Summary
#### Submitter
Dentis Co., Ltd. Jung Seob Guem #951, Woram-dong, Dalseo-Gu Daegu citv South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
### Official Correspondent Kodent Inc. April Lee 325 N. Puente st. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-01116
#### Device Information
Trade Name: HAPTITE Coating Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 2011-5-11
### General Description
This product is the operating, dental material as placed dental implant to inner part of maxillary to sustain, maintain prosthetic repair tooth or denture, mainbody (structure of subpart) is made by Titanium (Grade 4), is treated as blasting powder, and RBM at room temperature of CaP type to reduce Bone loss to bottom 1mm of the Machine Collar. Also, screw part of below 1 mm is treated as SHS (Super High Speed) RBM HA (Hydroxyapatite) Coating at room temperature. It is connected to structure of upper part as the type of the internal.
HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed.
By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer.
The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system.
The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment.
The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw,
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closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder ..
The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder).
i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part.
s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part.
The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm.
The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design.
The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.
### Indication for Use
The Dentis Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
### Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate device:
- DIO BIOTITE-H IMPLANT SYSTEM manufacture by DIO Deparment, DSI (K073070) .
- Replace HA coated implant manufactured by Nobel Biocare USA, INC. (K022424) .
Testing and other comparisons have established that the subject of HAPTITE implant system is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.
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| | Subject device | Predicate device | | |
|---------------------------|---------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>name | Dentis HAPTITE<br>Implant system | Dentis<br>Implant<br>System | DIO BIOTITE-H<br>IMPLANT SYSTEM | Replace HA Coated<br>Implant |
| 510(k)<br>number | N/A | K082843/<br>K073486 | K073070 | K022424 |
| Manufac<br>turer | Dentis Co., Ltd. | Dentis<br>Co., Ltd. | DIO Department, DSI,<br>Inc. | Nobel Biocare USA, Inc. |
| Intended<br>use | ldentical to<br>predicate devices | ldentical<br>to<br>predicate<br>devices | The implants are<br>indicated for surgical<br>placement in the<br>upper or lower jaw to<br>provide a means for<br>prosthetic attachment<br>in single tooth<br>restoration and in<br>partially or fully<br>edentulous spans with<br>multiple single teeth,<br>or as a terminal or<br>intermediary abutment<br>for fixed or removable<br>bridgework, and to<br>retain overdentures. | The implants are indicated<br>for surgical placement in<br>the upper or lower jaw to<br>provide a means for<br>prosthetic attachment in<br>single tooth restoration and<br>in partially or fully<br>edentulous spans with<br>multiple single teeth, or as<br>a terminal or intermediary<br>abutment for fixed or<br>removable bridgework, and<br>to retain overdentures. |
| Material | CP. GR.4<br>ASTM F67 | CP. GR.4<br>ASTM<br>F67 | CP. GR.3 and GR.4<br>ASTM F67 | CP. GR.3 and GR.4<br>ASTM F67 |
| Design | Tapered and<br>straight | Tapered<br>and<br>straight | Tapered | Straight |
| Implant<br>diameter | 3.7, 4.1, 4.3, 4.8,<br>5.5, 6.0, 6.5 and<br>7.0mm | 3.5, 3.7,<br>4.1, 4.3,<br>4.8, 5.1,<br>5.5, 6.0,<br>6.5 and<br>7.0mm | 3.8, 4.1, 4.5, 4.8, and<br>5.3mm | 3.5, 4.3, 5.0, 6.0mm |
| Implant<br>length | 7, 8, 9, 10, 12, 14<br>and 16mm | 7, 8, 10,<br>12 and<br>14mm | 8-14mm | 10,13,16mm |
| Attachm<br>ents | Various abutments<br>and components | Various<br>abutment<br>s and<br>compone<br>nts | Various abutments<br>and components | Various abutments and<br>components |
| Surface<br>treatment | HA coating | RBM | HA coating | HA coating |
| Coating<br>method | Super High Speed<br>Blast Coating<br>Process | Non<br>Coating | Electrochemical1 | Plasma-sprayed HA<br>coating2 |
| Coating<br>thickness<br>s | 1~2µm | 15±5µm1 | >5µm2 | |
| Solubility | insoluble | Soluble1 | Insoluble2 | |
| Surface<br>chemistry | 100% crystalline<br>HA | 95% Brushite + 5%<br>hydroxyapatite1 | Amorphous + crystalline<br>HA2 | |
| Shear<br>strength | $ \approx $ 37MPa | 13MPa1 | $ \approx $ 37.4MPa | |
| Morphology | Image: Morphology 1 | Image: Morphology 2 | Image: Morphology 3 | |
| Gamma<br>sterilized | Yes | Yes | Yes | |
| Product<br>Code | DZE | DZE | DZE | |
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## Non-clinical Testing data
- Measurement of the gap between fixture and abutment, rotational angle tests were successfully performed.
- Shear bonding strength test was successfully performed in accordance with ASTM F . 1147, 1044 as the result about 37 MPa over standard 34.5 MPa.
- Tensile bonding strength test was successfully performed in accordance with ASTM F -1147, 1044 as the result about 41 MPa over standard 34.5 MPa.
- -HA Coating Implant Graft Test in the pig bone for the evaluation of the stability of the coating layer was successfully performed.
- Roughness, Degree of crystallinity, Porosity, Cross section analysis, Density, Surface . area analysis, CaP ratio tests were successfully performed.
## Conclusion
The HAPTITE Coating Implant System, subject of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. HAPTITE Implant system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is believed to be substantially equivalent to Predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dentis Company, Limited Ms. April Lee Consultant Kodent Incorporated 325 N. Puente Street, Unit B Brea, California 92821
FEB - 1 2012
Re: K111364
Trade/Device Name: HAPTITE Coating Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: January 30, 2012 Received: January 30, 2012
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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### Page 2 - Ms. Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indication for Use
510(K) Number (if known):
K111364
HAPTITE Coating Implant System Device Name:
The HAPTITE Coating Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed This system is dedicated for one and two stage surgical procedures and not dedicated bridgework. for immediate loading. This system is intended for delayed loading
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Swer Rose
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
