(20 days)
The Metal Hemi Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
This document is a 510(k) premarket notification for a medical device called the "Metal Hemi Implant." 510(k)s are primarily focused on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study proving the device meets specific acceptance criteria in the way a diagnostic AI or interventional device might.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable or mentioned in this type of submission. This device is a physical implant, not a diagnostic algorithm or imaging device that would typically involve such studies.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (OrthoPro Hemi toe, K062908) | The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray. |
| Intended Use | Designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. |
| Material Composition | Substrate: CoCrMo alloy per ASTM F75. Plasma spray: commercially pure titanium per ASTM F67 on inferior surface and stem base. |
| Functional Design | Single stemmed resurfacing prosthesis for the first proximal phalanx. Concave congruent articular surface with mirror finish. Oval shape. Requires minimal bone resection. Provides full range of motion of the first metatarsophalangeal joint (MPJ). |
Explanation: For a 510(k) for an implantable device like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a previously legally marketed device (the predicate). The "device performance" is described through its design features, materials, and intended use, which are deemed equivalent to the predicate. There are no quantitative performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic algorithms.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable/Not provided. This is an implantable device, not a diagnostic algorithm tested on a dataset of patient images or readings.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/Not provided.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not provided.
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
- MRMC study: No, this is not an AI-assisted diagnostic device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an algorithm; it is a physical medical implant. Therefore, a standalone performance study in this context is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of ground truth: For a 510(k) of an implant, the "ground truth" for demonstrating substantial equivalence typically involves engineering testing (e.g., material testing, mechanical load testing, biocompatibility evaluations, sometimes cadaveric studies for range of motion or surgical technique), and clinical experience/literature supporting the safety and effectiveness of the predicate device and the materials used. The document states "The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray." This implies that the 'ground truth' for its performance aligns with the established performance of the predicate and the known properties of the materials.
8. The sample size for the training set
- Sample size: Not applicable/Not provided. This is a physical implant, not a machine learning model.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable/Not provided.
§ 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.