(81 days)
The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.
The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.
The MetaSurg cannulated titanium hemi implant is intended for single use only.
The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.
The provided document is a 510(k) summary for a medical device called the MetaSurg Cannulated Titanium Hemi Implant. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific performance metrics such as accuracy, sensitivity, or specificity. Therefore, many of the requested criteria for studies that evaluate device performance (like AI algorithms) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics typical for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on:
| Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (MetaSurg Cannulated Titanium Hemi Implant) |
|---|---|
| Indications for Use: Must be equivalent to predicate devices. | Indicated for treatment of degenerative arthritis in the 1st metatarsal joint, Hallux Limitus/Rigidus, Hallux Valgus, and pain/instability in the metatarsophalangeal joint. This aligns with predicate devices. |
| Material of Construction: Must be equivalent to predicate devices. | Made of Titanium Alloy (Ti-6AL-4V ELI). This aligns with predicate devices (implied through substantial equivalence claim). |
| Sizes: Must be comparable to predicate devices. | Offered in 5 sizes ranging from 15 - 23mm in diameter. This aligns with predicate devices (implied through substantial equivalence claim). |
| Shape: Must be equivalent to predicate devices. | Designed as an anatomical replacement for the base of the phalanx. This aligns with predicate devices (implied through substantial equivalence claim). |
| Implant Type: Must be equivalent to predicate devices. | Cannulated titanium hemi implant, intended for press fit, uncemented use. This aligns with predicate devices (implied through substantial equivalence claim). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for a physical implant, not a study involving a "test set" of data for performance evaluation in the context of AI or diagnostic accuracy. The substantial equivalence determination is based on device characteristics and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of evaluation is not performed for physical implants demonstrating substantial equivalence. The "ground truth" for the predicate devices would have been established through clinical use and regulatory clearance, which is then used as a reference point for the new device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described for this type of 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 device is a surgical implant, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of substantial equivalence, the "ground truth" is effectively the regulatory clearance and established safety and effectiveness of the predicate devices: Vilex hemi implant (K023684) and BioPro hemi implant (K041595). The new device is compared against these already-cleared devices based on their characteristics and intended use. No new clinical 'ground truth' in the sense of diagnostic accuracy is established in this document.
8. The sample size for the training set
Not applicable. This device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.