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The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis,

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques.
  Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.

• · Severe anteroposterior instability of the knee joint.

The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of the applicable information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. "Ground truth" in this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.

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

• No. This is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical knee implant, not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

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This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS Revision prosthesis is intended for cemented use only.

The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the implant and the therapeutic solution to the patients need. All the type of implants have been designed with the same objectives: to restore the joint line both in flexion and in extension without altering the patellar height, to restore the articular morphology and to preserve bone stock. The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a specific tibial bearing area during flexion. The HLS NOETOS System - Revision prosthesis consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a patellar implant. The patella can be preserved if it is in good state or resurfaced by the patellar implant. Femoral and tibial augments as well as femoral and tibial extension stems can be added in order to compensate for bone loss.

This is a 510(k) premarket notification for a medical device (HLS NOETOS System - Revision prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance (such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in the provided document.

The document describes a traditional medical device (knee joint prosthesis) and its substantial equivalence to predicate devices, which is a regulatory pathway that does not involve the type of performance evaluation typically conducted for AI/ML software.

The provided text focuses on:

• Device Name: HLS NOETOS System - Revision prosthesis
• Submitter: Tornier S.A.
• Classification: Class II medical device (Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis)
• Predicate Devices: PFC Modular Total Knee System (DePuy), NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK (Zimmer), HLS Noetos System (Tornier).
• Device Description: A total knee replacement system consisting of a femoral component, a tibial tray with a polyethylene bearing, and an optional patellar implant, designed to restore joint line, articular morphology, and preserve bone stock.
• Materials: Cobalt-Chromium alloy for femoral part, tibial tray, spacers, stem adaptors, and sleeve.
• Indications for Use: Total knee replacement for relief of pain and disability due to primary/secondary osteoarthritis and rheumatoid arthritis, and revision of knee prosthesis. Intended for cemented use only.
• FDA Decision: Substantial equivalence determination to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information in the format specified, as it pertains to AI/ML device evaluation, which is not relevant to this document.

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