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The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. Indications: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis 2. Correction of varus, valgus, or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint arthroplasty 8. Trauma These device components are for cemented use only.

The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. These device components are for cemented use only.

This document is a 510(k) premarket notification for the "Reduced Size Oncology Salvage System" by Biomet Orthopedics, Inc. It establishes substantial equivalence to a predicate device but does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval, not a performance study report.

Here's what I can extract/infer from the document regarding the device and its regulatory status:

• Device Name: Reduced Size Oncology Salvage System
• Applicant/Sponsor: Biomet Orthopedics, Inc.
• Legal Marketed Device to which Substantial Equivalence is Claimed (Predicate Device): Oncology Salvage System, K002757, Biomet, Inc.
• Indications for Use:
  • Treatment in small adults and children requiring proximal femoral, distal femoral, total femur, or proximal tibial replacements.
  • Resurfacing components for the proximal tibia and distal femur.
  • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
  • Correction of varus, valgus, or post-traumatic deformity.
  • Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
  • Ligament deficiencies.
  • Tumor resections.
  • Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques.
  • Revision of previously failed total joint arthroplasty.
  • Trauma.
• Usage: For cemented use only.
• Regulatory Classification: Class II device, Product Code: KRO, Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis (21 CFR 888.3510).
• Regulatory Action: FDA found the device substantially equivalent to a legally marketed predicate device.

Missing Information:

The provided text does not contain any information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size for human reader improvement.
6. Standalone performance study (algorithm only without human-in-the-loop).
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as an FDA clearance letter based on substantial equivalence to an existing device, implying that the safety and effectiveness were demonstrated by comparison to the predicate, rather than through new, independent clinical performance studies detailed in this specific document. Such information would typically be in a separate clinical study report or a more detailed submission accessible during the 510(k) review process, but not typically summarized in the public-facing "Summary of Safety and Effectiveness" or the FDA clearance letter itself.

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