(167 days)
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:
- 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.
- 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.
- Number of experts used and qualifications: Not applicable. There's no expert ground truth establishment for a specific test set.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human reader improvement with AI assistance.
- Standalone (algorithm only) performance: Not applicable. This device is a modular orthopedic implant, not an algorithm.
- 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).
- Sample size for the training set: Not applicable. There is no AI algorithm being trained.
- 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:
| Implied "Acceptance Criteria" (via substantial equivalence) | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | |
| Knee fatigue and wear test | Results demonstrate the device is safe, effective, and substantially equivalent to predicates. |
| Disassembly force testing for taper connections | |
| ASTM F1800-07 testing | |
| Clinical Performance: | |
| Equivalence to predicate devices in: | Clinical evaluation based on published papers and post-market surveillance concludes substantial equivalence. |
| - Intended Use | |
| - Indications for Use | |
| - Design/technological characteristics | |
| - Materials of composition | |
| - Method of sterilization | |
| - Performance data (non-clinical) | |
| - Clinical evaluation |
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.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.