K141043 · Consensus Orthopedics, Inc. · LPH · May 19, 2014 · Orthopedic
Device Facts
Record ID
K141043
Device Name
CS2 MULTI-HOLE ACETABULAR SHELL
Applicant
Consensus Orthopedics, Inc.
Product Code
LPH · Orthopedic
Decision Date
May 19, 2014
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3358
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The CS2™ Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - Non-union of proximal femoral neck fractures. - F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2™ and TAPERSET™ hip stems are indicated for cementless use. The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from theumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. - A. Proximal femoral fractures. - B. Avascular necrosis of the femoral head. - C. Non-union of proximal femoral neck fractures. - D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only.
Device Story
Acetabular shell component for total or partial hip arthroplasty; used in conjunction with mating inserts and optional bone screws for fixation. Device features hemispherical or flared rim designs with up to 10 screw holes for bone screw placement to augment initial fixation. Manufactured from titanium alloy with porous titanium bead coating. Insert options include UHMWPE or highly cross-linked polyethylene. Used by orthopedic surgeons in clinical settings. Provides mechanical support and articulation surface for hip joint replacement; screw holes allow surgeon to tailor fixation based on patient bone quality.
Clinical Evidence
No clinical data. Bench testing only; engineering design evaluation determined that the addition of screw holes did not necessitate further biomechanical testing.
Technological Characteristics
Acetabular shell: Titanium alloy (Ti 6Al-4V ELI, ASTM F620/F136) with porous CP Ti bead coating (ASTM F-67). Inserts: UHMWPE (ASTM F648) or highly cross-linked polyethylene (ASTM F2695). Bone screws: Wrought titanium alloy (Ti 6Al-4V ELI, ASTM F136). Features circumferential scallops for rotational security and optional apical dome hole plug/cement pod spacer. Non-software device.
Indications for Use
Indicated for patients with significantly impaired hip joints due to rheumatoid, osteoarthritis, or post-traumatic arthritis; revision of failed hip procedures; proximal femoral fractures; avascular necrosis; non-union of femoral neck fractures; congenital dysplasia; arthrodesis conversion; metabolic/tumorous conditions; osteomalacia; osteoporosis; pseudarthrosis; and structural abnormalities.
Regulatory Classification
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
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MAY 1 9 2014
K141043 Page 1 of 4
# 2. 510(k)SUMMARY
| Sponsor Name: | Consensus Orthopedics, Inc.<br>1115 Windfield Way, Suite 100<br>El Dorado Hills, CA 95762 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Matthew M. Hull, RAC<br>Phone: (916) 355-7156/ Fax: (916) 355-7190<br>mhull@consensusortho.com |
| Date Prepared: | 21 April 2014 |
| Trade Name: | Multi-Holed Shell for use with the CS2TM Acetabular Cup<br>System |
| Common Name: | Acetabular Shell |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis (21 CFR 888.3358, Product Code LPH)<br><br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (21 CFR 888.3353, Product<br>Code LZO) |
| Regulatory Class: | Class II |
Device Classification Panel: Orthopedic Devices
### Device Description:
The CS2 Acetabular Cup System consists of a shell and a mating insert. The acetabular component is designed for cemented or uncemented use. The acetabular shell is manufactured from titanium alloy (Ti 6Al-4V ELI, ASTM F620 or ASTM F136), with a porous coating of commercially pure titanium beads (CP Ti ASTM F-67).
The acetabular shells are available with or without screw holes in hemispherical or flared rim versions. The component has matching circumferential scallops on the shell and insert that rotationally secure the insert in the shell and allow for dialing the insert in a desired orientation. The shells with screw holes have up to 10 anatomically placed holes which accommodate optional bone screws to augment initial fixation. An optional apical dome hole plug and cement pod spacer are available. The acetabular insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648); highly cross linked polyethylene (UHMWPE, ASTM F648), or VitalitE (UHMWPE, ASTM F2695). They all feature a titanium alloy X-ray marker (Ti 6Al-4V ELI, ASTM F136).
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The cancellous bone screws are manufactured from wrought titanium alloy (Ti 6Al-4V ELI. ASTM F136). The cancellous bone screws are 6.5mm diameter and have a low profile head with a hex drive recess. These are provided with certain versions of the acetabular shell for the option of additional fixation.
### Indications for Use:
The CS2TM Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2 ™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM.
The indications for use are:
- A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C. Proximal femoral fractures.
- D. Avascular necrosis of the femoral head.
- E. Non-union of proximal femoral neck fractures.
- F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and turnorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2TM and TAPERSET™ hip stems are indicated for cementless use.
The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- A. Proximal femoral fractures.
- B. Avascular necrosis of the femoral head.
- C. Non-union of proximal femoral neck fractures.
- D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
UNIS YN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only.
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# Substantial Equivalence:
# Technological Characteristics/ Substantial Equivalence:
The intended use, materials, and design features of the subject Multi-Hole Shell for use with the CS2™ Acetabular Cup System are substantially equivalent to those of predicate devices manufactured by Consensus Orthopedics (Table 9.1). Previously cleared versions of the acetabular shell had from 3 to 5 screw holes, the new Multi-hole shell will offer options up to 10 screw holes. The safety and effectiveness of the Multi-hole Shell are adequately supported by the substantial equivalence information and materials data provided within this 510(k) submission.
# Table 9.1: Predicate device summary table.
| 510(k)<br>Number | Trade Name | 510(k) holder | 510(k) Clearance<br>Date |
|------------------|-----------------------------------|-----------------------------|--------------------------|
| K922561 | Consensus™ Total Hip System | Consensus Orthopedics, Inc. | 07/21/1993 |
| K060635 | Consensus Acetabular Shell System | Consensus Orthopedics, Inc. | 04/28/2006 |
# Legally Marketed Devices which are compatible:
K102399 (Consensus Orthopedics, Inc.) TAPERSET HIP SYSTEM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM K935193 (U.S. Medical Products) Consensus' Hip System - Porous Coated Titanium Femoral Stem
K935453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM
K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-PORQUS TITANIUM FEMORAL STEM
K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Femoral Head K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5. 0. +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K960156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD K960151(U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K021466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW
K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW
K100933 (Consensus) Consensus Acetabular insert. CS2 Plus
K110542 (Consensus) Consensus Biolox delta Ceramic Femoral Heads
K121263 (Consensus) TaperSet Hip System RDP Stem
K121935 (Consensus) TaperSet Hip System Small Stems
K120595 (Consensus) UniSyn Plus Hip Stem
K122512 (Consensus) CS2 Hip Stem
K130652 (Consensus) VitalitE Acetabular Insert
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# Non-Clinical Performance Data:
Engineering design evaluation of the additional screw holes being added to the acetabular shell shows that no additional biomechanical testing was required
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2014
Consensus Orthopedics, Inc. Mr. Matthew M. Hull QS & RA Director 1115 Windfield Way El Dorado Hills. California 95762
Re: K141043
Trade/Device Name: Multi-Hole Acetabular Shell for the CS2"14 Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: Class II Product Code: LPH, LZO Dated: April 21, 2014 Received: April 23, 2014
Dear Mr. Hull:
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 cither 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.
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
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Page 2 - Mr. Matthew M. Hull
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
# Lori A. Wiqqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### 1. INDICATIONS FOR USE STATEMENT
# 510(k) Number (if known): K141043
#### Device Name: Multi-Hole Acetabular Shell for the CS27M Acetabular Cup System
#### Indications for Use:
The CS2™ Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B.
- C. Proximal femoral fractures.
- D. Avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures. ﻨﻨﺎ
- F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2™ and TAPERSET™ hip stems are indicated for cementless use.
The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from theumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- A. Proximal femoral fractures.
- B. Avascular necrosis of the femoral head.
- C. Non-union of proximal femoral neck fractures.
- D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
UNISYN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only.
Prescription Use X (21 CFR Part 801 Subpart D)
AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Elizabethí@Ærank -S
Division of Orthopedic Devices
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.
