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The METS® Modular Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for:

Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies.
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma

The METS® Modular Distal Femur and its components are for single use only.

The METS® Modular Distal Femur and its components are for cemented use only.

The single use METS® Modular Distal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the distal femur. The stems of the system are intended for cemented use only. The system comprises a range of stems, collars hydroxyapatite (HA) coated or without, (stippled or smooth), a range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements, and in a rotating or fixed configuration).

The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

This document is a 510(k) premarket notification for a medical device called the METS® Modular Distal Femur. It provides information to demonstrate substantial equivalence to previously marketed devices, rather than establishing acceptance criteria or reporting on a study that proves the device meets specific performance criteria in the way envisioned by the prompt.

Therefore, the requested information elements related to acceptance criteria, device performance, study design, ground truth, and expert evaluation are not applicable or not available within this type of regulatory submission.

This submission focuses on non-clinical performance and a clinical evaluation based on existing literature and post-market surveillance of predicate devices.

Here's why each specific requested item is not found:

1. A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria or report performance against them in a comparative study. Instead, it asserts substantial equivalence by comparing the device's characteristics and non-clinical testing results to predicate devices.
2. Sample size used for the test set and the data provenance: There is no "test set" in the context of a prospective clinical study with a specific sample size. The clinical evaluation relies on previously published papers and post-market surveillance of predicate devices.
3. Number of experts used and qualifications: Not applicable. There's no expert ground truth establishment for a specific test set.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human reader improvement with AI assistance.
6. Standalone (algorithm only) performance: Not applicable. This device is a modular orthopedic implant, not an algorithm.
7. Type of ground truth used: Not applicable in the context of a new clinical study. The clinical performance conclusions are drawn from published papers and post-market surveillance of predicate devices, which would have their own forms of "ground truth" established during their original studies (e.g., patient outcomes, radiographic evaluation).
8. Sample size for the training set: Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

However, this document does describe "Performance Data: (non-clinical and clinical)".

Here's a summary of the available information regarding performance:

1. Table of "Acceptance Criteria" (as implied by equivalence to predicates) and Reported Performance:

2. Sample size used for the test set and the data provenance:

• Non-clinical testing: No specific sample sizes are provided for the knee fatigue, wear, disassembly force, or ASTM F1800-07 tests.
• Clinical evaluation: No specific "test set" or sample size for a prospective study is mentioned. The clinical evaluation was "carried out based upon published papers and post market surveillance" related to predicate devices. The provenance of this data would be from the original studies and post-market reports related to the predicate devices (K092138, K002757, K023087, K021489).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The clinical evaluation reviews existing literature rather than establishing new ground truth with experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards met. For the clinical evaluation, it relies on the "ground truth" established in the published papers and post-market surveillance of the predicate devices. This would typically include patient outcomes data, surgeon assessments, radiographic evaluations, and complication rates.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

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