(44 days)
The 3S Hemi Toe 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. This device is for uncemented use.
The 3S Hemi Toe 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 3S Hemi Toe requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
The provided document is a 510(k) summary for the "3S Hemi Toe Implant," which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally does not include extensive clinical studies with detailed acceptance criteria and performance metrics in the way that a new, high-risk device might.
The 510(k) process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness. Therefore, the document focuses on comparison to existing devices rather than presenting novel clinical study data with acceptance criteria.
Based only on the provided text, here is why a direct answer to your request regarding acceptance criteria and a study proving their fulfillment cannot be fully provided:
- No specific acceptance criteria are listed for the device performance. The document describes the device, its intended use, and compares its material and technological characteristics to predicate devices. It does not define quantitative performance metrics (e.g., success rates, complication rates, range of motion improvements) that the device must achieve to be considered "accepted."
- No dedicated clinical study is described that "proves the device meets the acceptance criteria." The 510(k) process generally doesn't require new clinical trials for substantial equivalence unless specific concerns about safety or effectiveness arise due to novel technology or intended use. The document relies on the existing safety and effectiveness of the predicate devices.
- The document explicitly states: "The 3S Hemi Toe does not incorporate any new technological characteristics as compared to the predicate device. The 3S Hemi Toe and the predicate devices are made from the same material." This indicates that the justification for market clearance is based on similarity to already approved devices, not on new performance data from a specific study.
Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" because this information is not present in the provided 510(k) summary.
However, I can extract the following relevant information about this device for context:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the
3S Hemi Toe Implant. The "acceptance" under the 510(k) pathway is based on demonstrating substantial equivalence to predicate devices regarding intended use and technological characteristics, and not raising new questions of safety and effectiveness. - Reported Device Performance: Not provided as specific clinical outcomes or statistical performance data from a dedicated study of the
3S Hemi Toe Implantin this document.
| Acceptance Criteria Category | Specific Metric/Threshold | Reported Device Performance | Comments |
|---|---|---|---|
| Intended Use | Same as predicate devices | Designed to supplement first metatarsal phalangeal joint arthroplasty; Indications: hallux limitus/rigidus, painful hallux valgus, revision of failed previous surgery, painful arthritis. (Matches predicate's use) | Substantially equivalent to predicate devices. |
| Technological Characteristics | Same as or similar to predicate devices, without raising new S&E questions | Fabricated from CoCrMo alloy per ASTM F799 or F75. Single stemmed resurfacing prosthesis; concave congruent articular surface with mirror finish; oval shape. | No new technological characteristics compared to predicates. |
| Material Safety | Biocompatibility consistent with predicate material | CoCrMo alloy per ASTM F799 or F75. | Same material as predicate devices, implying equivalent biocompatibility. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set or associated sample size is mentioned. The submission is based on comparison to predicate devices, not on a new clinical study with a test set.
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)
- Not applicable. No test set or ground truth establishment process is described in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 physical hemi toe implant, not an AI or imaging diagnostic device, so an MRMC study is irrelevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new clinical data requiring ground truth for validation is presented. The "ground truth" for the 510(k) pathway is the established safety and effectiveness record of the predicate device(s).
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is a physical device, not an AI or machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
§ 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.