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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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The Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

Indications:

• 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
• 2. Correction of varus, valgus, 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 devices are single use implants.

These devices are for cemented use only.

The Biomet® Oncology Salvage System offers a variety of component options for treatment of patients that require proximal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

There are twelve diaphyseal segment lengths available in 3cm, 4cm, and 5cm to 23 cm in 2cm increments. The diaphyseal segments are machined from wrought Ti-6AI-4V (ASTM F-1472). All the segments have a smooth satin finish.

This document describes a 510(k) premarket notification for the Biomet® Oncology Salvage System Diaphyseal Segments (OSS-K). It is a medical device submission seeking clearance, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical trial.

Therefore, many of the requested categories are not applicable to this type of regulatory submission. The submission aims to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific performance acceptance criteria through clinical studies.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

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

• Not Applicable. This submission is for regulatory clearance based on substantial equivalence to a predicate device, not a performance study with a test set in the clinical or AI context. The non-clinical testing involved surface finish analysis and mathematical calculations, but no "test set" of patients or data, as typically defined for performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth establishment by experts for a test set was described as this is a 510(k) submission based on substantial equivalence, not a clinical performance study requiring expert adjudication of data.

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

• Not Applicable. No test set or expert adjudication method was used for this 510(k) submission.

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

• Not Applicable. This device is a surgical implant (prosthesis components), not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This device is a physical implant, not an algorithm.

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

• Not Applicable. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to the legally marketed predicate device (Biomet® Oncology Salvage System (OSS)- K002757) based on technological characteristics and non-clinical testing, rather than a clinical ground truth established through expert consensus, pathology, or outcomes data for a new performance claim.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device or a clinical study for training purposes.

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

• Not Applicable. As there is no training set, no ground truth needed to be established for one.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device