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OSS INDICATIONS

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
   These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA).
   Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).

• Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
  COMPRESS INDICATIONS
  The Compress Segmental Femoral Replacement System is indicated for:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
   The Compress Segmental Femoral Replacement System components are intended for uncemented use.
   When components of the Orthopaedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.
   EXPANDABLE INDICATIONS
   The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
   The devices are single use implants intended for implantation with bone cement or with Biomet Compress.

The new devices included in this submission are additional components to Biomet's Orthopaedic Salvage System (OSS) that offer surgeons additional prostheses options to be used in limb salvage reconstruction. The new devices include proximal femoral components and tibial components.

The provided text describes a 510(k) premarket notification for the Biomet Orthopaedic Salvage System (OSS™) and related components. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical testing. As such, it does not contain the kind of detailed information about acceptance criteria for a device's performance, human reader studies, or training/test set specifics that would typically be found in an AI/ML device submission.

Therefore, many of the requested fields cannot be filled from this document. However, based on the information available, here's what can be provided and what cannot:

1. A 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)

This information is not provided in the document. The testing described is non-clinical (mechanical and material characterization), not involving human patient data or a "test set" in the context of AI/ML evaluation.

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)

This information is not applicable/provided for this non-clinical submission. Ground truth determination by experts is not relevant to the mechanical and material testing described.

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

This information is not applicable/provided for this non-clinical submission. Adjudication methods are typically used for establishing ground truth in clinical evaluations, which were not performed here.

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

This information is not applicable/provided. This submission is for a physical orthopedic implant, not an AI/ML diagnostic or assistive device that would involve human readers.

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

This information is not applicable/provided. This submission is for a physical orthopedic implant, not an AI/ML algorithm.

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

This information is not applicable/provided. The "ground truth" for the non-clinical tests would be established engineering standards, material properties specifications, and mechanical performance requirements, rather than clinical ground truth types listed.

8. The sample size for the training set

This information is not applicable/provided. There is no AI/ML training set involved in this submission.

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

This information is not applicable/provided. There is no AI/ML training set involved in this submission.

Summary of the Study:

The studies conducted for the Biomet Orthopaedic Salvage System (OSS™) - Proximal Femoral & Hybrid Tibial were non-clinical performance tests aimed at demonstrating the device's substantial equivalence to existing predicate devices.

The studies included:

• Device Fatigue Testing: Performed on proximal femoral and hybrid tibial components.
• Range-of-Motion (ROM) Analysis: Likely assessed the mechanical range of motion of the components.
• Material Characterization: Specifically for the OsseoTi™ material, confirming it is identical to previously cleared materials.

The conclusion of these non-clinical tests was that "the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices." No clinical testing was deemed necessary for this determination.

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