(87 days)
The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. The implants and instruments of the system are provided sterile for single use.
Here's a breakdown of the acceptance criteria and study information for the Nextra® PEEK Hammertoe Correction System, based on the provided FDA 510(k) summary:
This device did not undergo clinical testing to demonstrate substantial equivalence. Instead, the submission relies on non-clinical testing to compare its performance to predicate devices. This means that many of the typical elements of an AI/medical device performance study (like sample size, ground truth, expert adjudication, MRMC studies) are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Endotoxin limit of ≤ 20 EU per device (according to AAMI ST72, USP 161, USP 85) | Results met the Endotoxin limit of ≤ 20 EU per device. |
| Mechanical Strength | Substantially equivalent strength to predicate devices for intended use (according to ASTM F2193-18a) | Confirmed that the strength is substantially equivalent to predicate devices with similar indications and is adequate for its intended use through static and dynamic 3-point bend tests. |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for the non-clinical tests beyond "worst-case implant construct" for mechanical testing. Data provenance is not applicable as this was non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical testing (like material properties and mechanical strength) is established through standardized testing procedures and material specifications, not expert interpretation.
4. Adjudication method for the test set
Not applicable.
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
No, a multi-reader multi-case comparative effectiveness study was not done. This device is an implant, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation was based on:
- Standardized Endotoxin Limits: Defined by AAMI ST72, USP 161, and USP 85.
- Standardized Mechanical Testing Protocols: Defined by ASTM F2193-18a and comparison to the mechanical properties of legally marketed predicate devices.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.