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The Saiph® Knee System is intended for cemented only in the U.S. It is intended for single use in total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis and avascular necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of varus, valgus, or post traumatic deformity;

4. Correction or revision of unsuccessful osteotomy or arthrodesis;

5. Revision procedures where other treatments or devices have failed; and

6. Treatment of fractures that are unmanageable using other techniques.

The Saiph® Knee System is used in total knee replacement to replace articulating surfaces of the femur, tibia and patella. The device is intended for cemented fixation only. The patella is optional depending upon surgeon preference and is cemented use only. The femoral and tibial tray components are made from cast cobalt chrome. The tibial bearing and patella components are made from ultra-high molecular weight polyethylene (UHMWPE). The femoral component is highly polished to articulate with the tibial bearing. All devices are gamma irradiated.

The provided document describes the Saiph® Knee System, a knee prosthesis, and its submission for 510(k) premarket notification. The information pertains to the device's technical characteristics and performance testing to establish substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

However, I can extract information regarding the device's performance, the type of studies conducted, and the ground truth used for validation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Non-clinical tests: The document does not specify a separate "test set" sample size for the non-clinical (physical) tests. These tests are typically conducted on a representative number of device components based on engineering standards and protocols.
• Clinical data:
  • UK National Joint Registry: 127 procedures. Data provenance: UK, retrospective.
  • Multi-center post-market study: 282 implants. Data provenance: Australia and UK, prospective (ongoing study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided document. The "ground truth" for the non-clinical tests would be defined by engineering standards and measurements, while the "ground truth" for clinical outcomes (revisions, device failures) is based on medical records and follow-up data as reported by healthcare providers and registries. There is no mention of experts establishing a ground truth for a test set in the context an AI/ML study.

4. Adjudication Method for the Test Set

Not applicable. The clinical outcomes (revisions, device failures) are reported events, not interpretations by multiple experts requiring adjudication in the context of an AI/ML algorithm evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a physical knee prosthesis, not an AI/ML diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical knee prosthesis, not an AI/ML algorithm.

7. The Type of Ground Truth Used

• Non-clinical tests: Engineering and biomechanical measurements, established through standardized testing methods (e.g., fatigue strength, contact stress). The "ground truth" is based on the physical properties and performance of the device under simulated conditions.
• Clinical data:
  • Registry data: Patient outcomes (e.g., presence or absence of revision surgery) as recorded in a national joint registry. This reflects actual clinical outcomes.
  • Post-market study data: Patient outcomes (e.g., revisions, device-related failures) collected during an ongoing prospective clinical study. This also reflects actual clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is a physical knee prosthesis and does not involve AI/ML "training sets."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

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