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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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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 Biomet Side Access Distal Femoral Expandable Knee is an additional component to Biomet's Orthopedic Salvage System (OSS) that gives the surgeon the ability to expand the prosthesis as the patient grows. All expansion takes place where natural bone has been removed. The device does not lengthen existing bones. The expandable device is available in standard and Reduced Size (RS) and is compatible with Biomet OSS system components and Compress (CPS) devices.

The provided text describes the Biomet Side Access Distal Femoral Expandable knee implant and a summary of its non-clinical performance data. Here's an analysis of the available information regarding acceptance criteria and the study proving it:

Summary of Acceptance Criteria and Reported Device Performance:

The document states that cyclic fatigue testing was conducted. However, specific quantitative acceptance criteria for this test (e.g., number of cycles, load levels, maximum allowable deformation or failure) are not detailed in this summary.

The reported device performance is a general statement:

Detailed Information as Requested:

1. Table of acceptance criteria and the reported device performance:
   (As provided above) It's important to note the lack of specific, quantitative acceptance criteria in the summary. The performance is stated in qualitative terms related to adequacy, intended use, and equivalence.

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

   • Sample Size: The document does not specify the sample size used for the cyclic fatigue testing or any other mechanical tests.
   • Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given it's non-clinical, the concept of "prospective" or "retrospective" as it applies to human clinical trials is less relevant; these would be controlled laboratory studies.

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 to this submission. The tests described are "non-clinical" mechanical performance tests (cyclic fatigue). Ground truth, in the context of expert consensus, is typically established for diagnostic or clinical performance studies involving human readers or adjudicators, not for mechanical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable. Adjudication methods are relevant for clinical studies where subjective assessments (e.g., image interpretation, clinical outcomes) require expert review to establish a ground truth. Mechanical testing relies on objective measurements and established engineering standards, not adjudication.

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. This submission describes a mechanical knee implant and its non-clinical performance testing. It does not involve AI, image analysis, human readers, or diagnostic performance evaluation. Therefore, an MRMC comparative effectiveness study is entirely outside the scope of this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. As mentioned above, this device is a mechanical implant, not an algorithm or an AI-powered system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for mechanical performance tests like cyclic fatigue is typically established by engineering standards and specifications. The device is tested against predefined load conditions, cycles, and failure criteria (e.g., no fracture, no significant deformation, maintaining functional integrity) as outlined in relevant ASTM or ISO standards for orthopedic implants. The document implies compliance with these standards through the statement "Testing verified that the accuracy and performance of the system is adequate to perform as intended."

8. The sample size for the training set:
   This information is not applicable. There is no "training set" for a mechanical device as it does not involve machine learning or AI.

9. How the ground truth for the training set was established:
   This information is not applicable. Since there is no training set, there's no ground truth to establish for it.

In conclusion, the provided document focuses solely on the non-clinical mechanical performance of a knee implant. It confirms that cyclic fatigue testing was performed, and the results indicated the device met its intended use and demonstrated substantial equivalence to predicate devices. However, it lacks specific quantitative acceptance criteria, sample sizes for testing, and details about the testing methodology beyond stating "cyclic fatigue was conducted" and "mechanical testing." Information related to clinical studies, AI, human readers, or expert ground truth establishment is not relevant to this type of non-clinical device submission.

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