(207 days)
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis.
The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cemented use only.
The Topez prosthesis is a total ankle joint replacement medical device. It is a semiconstrained, cemented prosthesis. It is intended to be an equivalent product to the DePuy's FDA-cleared "Agility" model, with the same indications for use.
Components: Listed below are the components comprising the Topez ankle prosthesis assembly.
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- Tibial-side replacement (tibial platform): This is a titanium (Ti-6A1-4V, ELI) structural component that holds and secures the Ultra High Molecular Weight Polyethylene (UHMWPE: GUR 1020, ASTM F648) component and interfaces with the Tibial Stem Assembly (both described below)
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- UHMWPE: This is a concave component that replaces the physiological distal end of the tibia. It is one of the two major bearing surfaces in the ankle joint replacement system. The UHMWPE snap-locks within a tibial platform using a design similar to knee replacement systems.
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- Tibial Stem Assembly: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the tibial platform component is secured to the tibia. It consists of 4 titanium cylinders that are screwed together to form a long stem up within the center of the tibia. There are four components to be inserted through a small anterior incision in the ankle, screwed together and then pushed up into the center of the drilled tibia. The 4-stem assembly is finally secured to the tibial platform with a Morse taper lock system that is common with joint implants.
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- Talar-side replacement (talar platform): This is a convex Cobalt-Chrome (Co-Cr-Mo, ASTM F1537) bearing surface on the talar side of the ankle joint. In concert with the UHMWPE, it forms the sliding-rotating joint interface of the ankle joint. It serves the second function of providing the interface-anchor to the talus.
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- Talar Stem: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the talar platform component is secured to the talus. The Talar Stem is attached to the Talar platform with a Morse taper lock system that is common with joint implants.
The Topez prosthesis is comprised entirely of materials now used for other implant products. The Topez ankle is intended to be used with a tibial anchor that is larger than those that are typically seen with ankle prostheses. The Topez ankle utilizes a Foot-Leg holder assembly with jigs and fixtures intended to assist the surgeon with an accurate and simple prosthesis installation tool-kit.
The provided document is a 510(k) summary for the Topez Total Ankle Replacement device. It describes the device, its indications for use, and comparisons to a predicate device. The document does not include information about clinical studies with human participants, expert review processes, or AI/software performance. The device is a physical implant, not a software or AI-driven diagnostic tool, so many of the requested categories (like "number of experts," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance") are not applicable or relevant to this type of device submission.
The acceptance criteria and device performance are based on non-clinical data, primarily mechanical and material testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Risk Management following ISO 14971 | Acceptable and mitigated potential hazards (supported by FEA and FMEA) | PASSES |
| Structural materials meet ASTM standards: Cobalt-Chromium-Molybdenum | ASTM F1537 | Meets standard |
| Structural materials meet ASTM standards: Titanium, Ti-6A1-4V ELI | ASTM F136 | Meets standard |
| Structural materials meet ASTM standards: UHMWPE, GUR1020 | ASTM F648 | Meets standard |
| Test 1: Determining the Contact Surface Area and Stresses of Articulating Surfaces | Not explicitly stated beyond "reduced material stresses" compared to predicate, but passed | PASSES |
| Test 2: Determining the Constraint Characteristics | Not explicitly stated | PASSES |
| Test 3: Determining the Disassembly Strength of Tibial Tray and UHMPWE Insert (with and without Joint Reaction Force) | Not explicitly stated | PASSES |
| Test 4: Test Protocol for Determining the Fatigue Strength of Tibial Stems | Not explicitly stated | PASSES |
| Test 5: Test Protocol for Disassembly Strength of a Calcaneal Stem | Not explicitly stated | PASSES |
| Test 6: Determining the Assembly/Disassembly Strength of the Tibial Stem | Not explicitly stated | PASSES |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for each mechanical test. The tests are non-clinical (laboratory/bench testing) and therefore do not involve patient data or human participants. The data provenance is laboratory testing conducted by the manufacturer, Topez Orthopedics, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical implant, and its performance is evaluated through material and mechanical testing, not by expert interpretation of data like images.
4. Adjudication method for the test set
Not applicable. This is a physical device undergoing mechanical property testing.
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 is a physical implant, not a software or AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant.
7. The type of ground truth used
The "ground truth" for this medical device's performance is established through adherence to ASTM standards for materials and validated mechanical testing protocols. The "PASSES" for each test indicate that the device met pre-defined engineering and material specifications, which serve as the ground truth for its physical and mechanical properties.
8. The sample size for the training set
Not applicable. The device is a physical product, not an AI model.
9. How the ground truth for the training set was established
Not applicable. The device is a physical product, not an AI model.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.