(201 days)
The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only.
Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- . Hallus rigidus stage 3 and 4
- . Hallux valgus and hallux rigidus
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
The Arthrosurface® Total Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 15 metatarsal head and the base of the proximal phalanx. These two implants replace the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.
The Metatarsal Implant incorporates a CoCrMo articular resurfacing component per ASTM F799 with CP Ti Plasma Spray coating per ASTM F1580 and a Ti-6AI-4V ELI alloy fixation component per ASTM F136 that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The device is 15mm articular implant with a dorsal flange feature for additional implant coverage in the dorsal plane.
The Proximal Phalanx Implant consists of a Ti-6Al-4V ELI alloy fixation component per ASTM F136 with CP Ti Plasma Spray coating per ASTM F1580 and an Ultra High Molecular Weight Polyethylene inlay per ASTM F648.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrosurface® Total Toe - Proximal Phalanx Implant:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantifiable acceptance criteria such as "the device must achieve X performance metric." Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
The acceptance criteria can be inferred from the list of non-clinical tests performed, with the implication that the device's performance in these tests was acceptable and comparable to the predicate devices.
| Acceptance Criteria (Inferred from Test Performed) | Reported Device Performance |
|---|---|
| Wear testing | Demonstrated safety and effectiveness; substantially equivalent to predicates. |
| Contact area / Contact stress | Demonstrated safety and effectiveness; substantially equivalent to predicates. |
| Assembly / Disassembly of Articular and Fixation components | Demonstrated safety and effectiveness; substantially equivalent to predicates. |
| Bending moment / Flexural load | Demonstrated safety and effectiveness; substantially equivalent to predicates. |
| Strength of delivery tool | Demonstrated safety and effectiveness; substantially equivalent to predicates. |
| Finite Element Analysis | Demonstrated safety and effectiveness; substantially equivalent to predicates. |
Explanation: The document explicitly states: "The results have demonstrated the safety and effectiveness of the Arthrosurface® Total Toe - Proximal Phalanx Implant along with substantial equivalence to the predicate devices." This is the overarching performance claim based on the non-clinical tests.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical (bench) testing, not clinical studies involving human subjects or data. Therefore:
- Sample Size for Test Set: Not specified in terms of human subjects or patient data. For bench testing, the sample size would refer to the number of physical devices or components tested, which is not provided.
- Data Provenance: Not applicable as it's non-clinical testing. It's not retrospective or prospective patient data from any specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device underwent non-clinical bench testing to establish its performance and substantial equivalence. "Ground truth" in the context of expert consensus regarding patient data or images is not relevant here. The ground truth for the engineering tests would be the established scientific and engineering principles, material properties, and test standards (e.g., ASTM standards referenced).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or image review where inter-rater variability needs to be managed for establishing ground truth. This was non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a physical orthopedic implant undergoing non-clinical testing for substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This type of study refers to the performance of an AI algorithm independent of human interaction, which is not applicable to a physical medical device like an orthopedic implant.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests conducted would be based on:
- Established engineering standards and methodologies: (e.g., ASTM F799, ASTM F1580, ASTM F136, ASTM F648 for material properties).
- Physical measurements and observations during the wear, contact, assembly, bending, and strength tests.
- Computational models and simulations for the Finite Element Analysis.
8. Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/ML device that requires a training data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there's no ground truth establishment for it.
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