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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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• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 5. Revision procedures where other treatment or devices have failed.

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

Additional indications for Biomet G7 Freedom™ Constrained Liners:

The Biomet G7 Freedom™ Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 OssetoTi™ Acetabular Shells are part of the G7™ Acetabular System, designed to provide numerous options for surgeons and patients in one modular compatible system. The OsseoTi™ Shell utilizes an outer surface porous region produced by additive manufacturing using titanium alloy powder (ASTM F2924). This structure leads to a highly interconnected volume of porosity and promotes biological fixation through tissue ingrowth. The shell is available in either a limited hole or multi-hole design. The inner diameter and locking mechanisms are identical to the previously cleared shells of the G7™ Acetabular System, K121874, and will be compatible with the G7™ Acetabular System's E1™ and ArComXL™ polyethylene acetabular liners, as well as all modular components and instrumentation included in K121874.

The provided document is a 510(k) premarket notification letter from the FDA to Biomet, Incorporated, regarding their G7 OsseoTi™ Acetabular Shells. It describes the device, its indications for use, and a summary of non-clinical testing performed to establish substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI-powered medical device.

The information provided pertains to a traditional orthopedic implant (hip replacement component) and focuses on mechanical and material characterization, not AI algorithm performance. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The non-clinical testing listed covers:

• Mechanical Testing: Deformation, Torsional, Fatigue (anatomic and unsupported), Poly Push Out, Poly Lever Out, Poly Torque Out Testing.
• OsseoTi™ Material Characterization: Chemical Composition, Interconnected Porosity, Average Pore Size, Porosity Volume, Roughness, Tensile Adhesion, Abrasion Resistance, Static Shear Strength, Shear Fatigue, Compressive Strength, Elastic Modulus.
• Other: Animal Data.

The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Without information regarding an AI component, I cannot fulfill the request as it is framed for AI device evaluation.

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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.

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 distal femoral component, proximal femoral component, proximal tibial sleeve, diaphyseal segment, splined stem, diaphyseal augment and metaphyseal augment.

I am sorry, but the provided text does not contain the level of detail required to answer your request regarding acceptance criteria and study information for a medical device. The document is a 510(k) summary for a medical device (Biomet Orthopaedic Salvage System (OSS) Line Extension) indicating substantial equivalence to predicate devices, but it does not include:

1. A table of acceptance criteria and reported device performance: The document lists "Device Fatigue Testing", "Device Static Disassociation Testing", "Tensile Properties Testing", and "Material Characterization for OsseoTi" as performed tests, but does not provide specific acceptance criteria or the numerical results of these tests.
2. Sample sizes used for the test set and data provenance: No information on sample sizes (N) for any of the non-clinical tests is given.
3. Number of experts used to establish ground truth and their qualifications: This is not applicable as no clinical study for ground truth establishment is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "No clinical testing was necessary for a determination of substantial equivalence." and "Clinical Performance Data/Information: N/A". Therefore, no MRMC study was conducted.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is not applicable as the device is a physical orthopedic implant system, not a software algorithm.
7. Type of ground truth used: Not applicable as no clinical study requiring ground truth was conducted.
8. Sample size for the training set: Not applicable as this relates to AI/machine learning models, and the device is a physical implant.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing and material characterization, without the need for new clinical studies to establish safety and effectiveness for a novel performance claim.

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