Orthopaedic Surgery Planning Software (AIJOINT)

K233761 · Longwood Valley Medical , Ltd. · LLZ · Aug 5, 2024 · Radiology

Device Facts

• Record ID: K233761
• Device Name: Orthopaedic Surgery Planning Software (AIJOINT)
• Applicant: Longwood Valley Medical , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

This product is used in medical institutions, it can carry out 3D reconstruction, segmentation and semi-automatic identification of key points on CT images conforming to DICOM3.0 standard format, and assist physicians to overlay digital templates to assist surgeons with preoperative planning of adult hip and total knee replacement surgery. This product is intended for use by trained and qualified physicians and cannot be used as a basis for clinical diagnosis and treatment decisions alone.

Device Story

Standalone software for preoperative planning of adult hip and total knee replacement surgery; inputs CT images in DICOM 3.0 format; performs 3D reconstruction, image segmentation, and semi-automated identification of anatomical key points; allows surgeons to overlay digital templates of prosthetic materials; used in medical institutions by trained physicians; output assists surgeons in surgical simulation and planning; does not provide clinical diagnosis or treatment decisions; benefits include improved surgical planning efficiency and accuracy.

Clinical Evidence

No clinical data. Bench testing only. Validation included accuracy testing of key point recognition (error <1mm; 95% CI), image segmentation (mean Dice coefficient 0.9483; mean Hausdorff Distance 1.2917 across 200 cases), output parameter accuracy (length <1mm, angle <1°), prosthesis model consistency (deviation <0.5mm), and acetabular cup coverage accuracy (±3%).

Technological Characteristics

Standalone software; runs on Windows PC; processes DICOM 3.0 CT images; utilizes 3D reconstruction, segmentation, and semi-automated anatomical identification algorithms; supports digital prosthetic templates; software verification and validation performed per FDA guidance.

Indications for Use

Indicated for adult patients undergoing hip and total knee replacement surgery. Intended for use by trained and qualified physicians in medical institutions for preoperative planning. Not for use as a sole basis for clinical diagnosis or treatment decisions.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• PeekMed (K182464)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Longwood Valley Medical Ltd Wei Yuanyuan RA Manager 2201 Floor 22, Tower 1, No.2 Ronghua South Rd., BDA 100176 Beijing, China

August 5, 2024

## Re: K233761

Trade/Device Name: Orthopaedic Surgery Planning Software (AIJOINT) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: July 1, 2024 Received: July 1, 2024

Dear Wei Yuanyuan :

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K233761

Device Name

Orthopaedic Surgery Planning Software (AIJOINT)

#### Indications for Use (Describe)

This product is used in medical institutions, it can carry out 3D reconstruction, segmentation and semi-automatic identification of key points on CT images conforming to DICOM3.0 standard format, and assist physicians to overlay digital templates to assist surgeons with preoperative planning of adult hip and total knee replacement surgery. This product is intended for use by trained and qualified physicians and cannot be used as a basis for clinical diagnosis and treatment decisions alone.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# K233761-510(k) Summary

# Date of Preparation: 7/31/2024

- 1. Sponsor Identification
#### Longwood Valley Medical LTD.

Address: 2201 Floor 22, Tower 1, No.2 Ronghua South Rd., BDA 100176 Beijing, China Contact Person: Peng Chen Position: RA manager Tel: [phone] Email: [e-mail]

- 2. Designated Submission Correspondent
Mr. Peng Chen (Primary Contact Person) Ms. Yuanyuan Wei (Alternative Contact Person)

#### Longwood Valley Medical LTD.

2201 Floor 22, Tower 1, No.2 Ronghua South Rd., BDA 100176 Beijing, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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#### Identification of Proposed Device 3.

Trade Name: Orthopaedic Surgery Planning Software (AIJOINT) Common Name: Pre-operative planning software

#### Regulatory Information

Regulation Name: Medical image management and processing system Classification: Class II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

#### Indication for Use:

This product is used in medical institutions, it can carry out 3D reconstruction, segmentation and semi-automatic identification of key points on CT images conforming to DICOM3.0 standard format, and assist physicians to overlay digital templates to assist surgeons with preoperative planning of adult hip and total knee replacement surgery. This product is intended for use by trained and qualified physicians and cannot be used as a basis for clinical diagnosis and treatment decisions alone.

- Identification of Predicate Devices 4.
510(k) Number: K182464 Product Name: PeekMed

Indications for Use:

PeekMed is a software system designed to help surgeons' specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies.

The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies.

PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.

#### Device Description న్.

The proposed device, Orthopaedic Surgery Planning Software, is standalone software which is designed to help surgeons' specialists carry out the pre-operative planning for an adult hip and total

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knee replacement surgery for several surgical procedures, based on the patient's CT images.

The Orthopaedic Surgery Planning Software can a carry out 3D reconstruction, segmentation and semi-automated identification of anatomical sites of CT images conforming to DICOM3.0 standard format, and assist physicians to simulate adult hip and total knee replacement surgery.

Substantially Equivalent (SE) Comparison 6.

| ITEM | Proposed Device | Predicate Device K182464 | Remark |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product name | Orthopaedic<br>Surgery<br>Planning Software | PeekMed | / |
| Regulation No. | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Class | II | II | Same |
| Intended for Use | A pre-operative planning<br>software for surgery | A pre-operative planning<br>software for surgery | Same |
| Indication for Use | This product is used in<br>medical institutions, it can<br>carry out 3D<br>reconstruction,<br>segmentation and<br>semi-automatic<br>identification of key points<br>on CT images conforming<br>to DICOM3.0 standard<br>format, and assist<br>physicians to overlay<br>digital templates to assist<br>surgeons with preoperative<br>planning of adult hip and<br>total knee replacement<br>surgery. This product is<br>intended for use by trained<br>and qualified physicians<br>and cannot be used as a<br>basis for clinical diagnosis<br>and treatment decisions | PeekMed is a software system<br>designed to help surgeons'<br>specialists carry out the<br>pre-operative planning in a<br>prompt and efficient manner for<br>several surgical procedures, based<br>on their patients' imaging studies.<br>The software imports diagnostics<br>imaging studies such as x-rays,<br>CT or magnetic resonance image<br>(MRI). The import process can<br>retrieve files from a CD ROM, a<br>local folder or the PACS. In<br>parallel, there is a database of<br>digital representations related to<br>prosthetic materials supplied by<br>their producing companies.<br>PeekMed allows health<br>professional to digitally perform<br>the surgical planning without<br>adding any additional steps to | Similar<br>Analysis<br>1 |
| | | | |
| | alone. | that process. This software | |
| | | system requires no imaging study | |
| | | acquisition specification (no | |
| | | protocol). Experience in usage | |
| | | and a clinical assessment are | |
| | | necessary for a proper use of the | |
| | | software. | |
| | | PeekMed allows the surgeon to | |
| | | perform the pre-surgical planning | |
| | AIJOINT allows the | efficiently in the following | |
| | surgeon to perform the | subspecialties: | |
| | pre-surgical planning | | |
| | efficiently in the following | - Hip | |
| | subspecialties: | - Knee | |
| | - Hip | - Spine | |
| | | - Upper Limb | |
| | - Knee | - Foot and Ankle | |
| | | - Trauma | |
| | | For each subspecialty, there are | |
| | For each subspecialty, there | several procedures: | |
| | | | |
| | are several procedures: | | |
| | | -Hip: | |
| | -Hip: | Hip Dysplasia Correction, | |
| | Hip Dysplasia Correction, | Limb Length Discrepancy, | |
| | Limb Length Discrepancy, | Center of Rotation - Ranawat | Different |
| Subspecialties | Acetabular Angle, | method, | Analysis |
| | Hip Arthroplasty | Acetabular Angle, | 2 |
| | | | |
| | | Total Hip Arthroplasty | |
| | | -Knee: Leg Deformity | |
| | -Knee: Knee Arthroplasty | Correction, AP Knee Resection, | |
| | | AP Full Leg | |
| | | resection, High Tibial Osteotomy, | |
| | | ACL Tunnel Reconstruction, | |
| | | Medial Patellofemoral Ligament | |
| | | | |
| | / | -Spine: Single Cobb Angle,<br>Thoracic Kyphosis Angle,<br>Lumbar Lordosis Angle, Sagittal<br>Vertical Axis, Pelvic Angles,<br>Coronal Balance, Sacro- femoral<br>Angle, Sagittal Balance, | |
| | | Smith-Petersen | |
| | Osteotomy, Pedicle Subtraction Osteotomy | | |
| | -Upper Limb: Total Shoulder Replacement, Clavicular Angle, Shoulder Resurfacing | | |
| | -Foot and Ankle: Talar Tilt, Hallux Valgus, Moreau-Costa-Bertani Internal Angle, Moreau- Costa-Bertani External Angle, Maestro Formula | | |
| | -Trauma: Diaphyseal Shaft Fracture Angle, Metaphyseal Shaft Fracture Angle, Roof Arc | | |
| Patient Population | Adults | Adults and pediatrics…