(105 days)
The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.
This document is a 510(k) summary for the Hammertoe Truss System (HTS), a medical device intended for fixation of osteotomies and reconstruction of lesser toes. It does not describe an AI/ML powered device, and therefore the requested information about acceptance criteria and studies proving the device meets them in the context of AI/ML are not applicable here.
However, I can extract the relevant performance testing information for this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical thresholds for each test. Instead, it refers to performance testing completed "per the following standards," implying that compliance with these standards and their methodologies serves as the acceptance criteria. The "reported device performance" is implicitly that the device met these standards, leading to the conclusion of substantial equivalence.
| Acceptance Criteria (Standard) | Reported Device Performance (Implicit) |
|---|---|
| ASTM F1264 – Static and Dynamic 3-Point Bend and Torque to Failure | Hammertoe Truss System meets the standard for these mechanical properties. |
| ASTM F543 – Axial Push Out | Hammertoe Truss System meets the standard for axial push out force. |
| ASTM F2119 — MR Image Artifact | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR image artifact. |
| ASTM F2052 - MR Induced Displacement Force | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR induced displacement force. |
| ASTM F2213 – MR Induced Torque | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR induced torque. |
| ASTM F2182 – MR Induces Heating | Hammertoe Truss System does not present a new worst case compared to the predicate device in terms of MR induced heating. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance testing has been completed per the following standards," but does not detail the specific sample sizes used for each test or the provenance of any data.
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)
This is not applicable as this is not an AI/ML device requiring expert-established ground truth for a test set. The performance is based on physical and material testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this physical medical device, the "ground truth" or standard for performance is adherence to established ASTM mechanical and MR compatibility standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore does not have a training set.
§ 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.