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The restor3d MTP Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is a single use implant intended to be press fit with optional use of bone cement.
The restor3d MTP Implant is a sterile, single use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement.
The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished.
The provided document is a 510(k) premarket notification for a medical device called the "restor3d MTP Implant". It focuses on establishing substantial equivalence to a predicate device rather than describing an AI/ML powered device or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not present in this document.
However, I can extract the information related to the device's performance testing to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes a set of performance tests conducted to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the restor3d MTP Implant performs similarly to or meets the standards demonstrated by the predicate device for the specified tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable performance to predicate device in monotonic compression-subsidence | Performance was sufficient to support the assertion of substantial equivalence. |
| Comparable performance to predicate device in monotonic compression | Performance was sufficient to support the assertion of substantial equivalence. |
| Comparable performance to predicate device in monotonic bending-pullout | Performance was sufficient to support the assertion of substantial equivalence. |
| No significant difference from predicate device in monotonic bending | Performance was sufficient to support the assertion of substantial equivalence. |
| Acceptable surface roughness characteristics | Analysis was conducted, and performance was sufficient to support the assertion of substantial equivalence. |
| Acceptable performance in monotonic shear, shear fatigue, and abrasion for modified metallic surfaces | Tests were conducted, and performance was sufficient to support the assertion of substantial equivalence. |
| Acceptable performance in gravimetric and comparative particulate analysis | Tests were conducted, and performance was sufficient to support the assertion of substantial equivalence. |
| No new questions of safety or effectiveness identified during testing. | No new questions of safety or effectiveness were identified. |
2. Sample size used for the test set and the data provenance
This document does not describe tests related to AI/ML or diagnostic performance based on data sets. The tests mentioned are mechanical and material property tests of the physical implant. Therefore, "sample size for the test set" in the context of image data or patient data, and "data provenance" (country of origin, retrospective/prospective) are not applicable or mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a physical medical device (implant) and the document describes mechanical/material testing, not diagnostic performance evaluated by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies, which is not the subject of this 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 document is for a physical orthopedic implant, not an AI/ML-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical orthopedic implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical and material tests described, the "ground truth" would be established by adherence to recognized engineering standards and test methods. For example, material properties are verified against industry standards for cobalt-chromium alloys, and mechanical tests (compression, bending, shear, fatigue, abrasion) would be assessed against benchmarks derived from the predicate device's performance or industry-accepted performance criteria for such implants. The document does not specify these detailed standards but implies compliance with generally accepted testing methodologies for orthopedic implants.
8. The sample size for the training set
Not applicable. There is no mention of an AI/ML component or a training set.
9. How the ground truth for the training set was established
Not applicable. There is no mention of an AI/ML component or a training set.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.