(44 days)
The PRO-TOE® Hammenoc Fixation Systems are indicated for the fixation of ostconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammerton Fixation Systems can be used with K-wires for the delivery of implants of the temporary stabilization of outlying joints (c.g. MTP Joint).
The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for inscrion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteonomics and reconstruction of the lesser toc following correction procedures for hammerloe, claw toe, mallet toe, and metatarsophalangeal joint instability.
The PRO-TOE® Hammetoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and will be offered in multiple sizes. The implants are manufactured from stainless steel or titanium.
This submission seeks to add previously cleared WMT Implantable K-Wires to the system for use with cannulated implants, for which clearance is also sought in this submission. The WMT Implantable K-wires are offered in surgical grade stainless steel. A range of diameters and lengths are offered from the manufacturer and planning should be conducted prior to implantation to determine the best fit.
The provided document is a 510(k) summary for the PRO-TOE® Hammertoe Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance metrics is not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of what can be inferred or explicitly stated based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission like this is typically substantial equivalence to legally marketed predicate devices. This means the new device performs at least as well as the predicate and does not raise new questions of safety or effectiveness. Specific quantifiable performance criteria (e.g., success rates, complication rates) are generally not established or reported in this type of document for new predicate devices.
- Reported Device Performance: The document states that "Mathematical mechanical analysis related to static bend testing has shown that the subject implants do not present a new worst case." This is the only performance-related statement, indicating that the mechanical properties are at least equivalent to or better than the predicate in certain aspects. No clinical performance metrics are provided.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance (from document) |
|---|---|
| Substantial Equivalence to predicate | Mathematical mechanical analysis showed no new worst-case (static bend testing). |
| No new questions of safety or effectiveness | Concluded that the "design characteristics... do not raise any new types of questions of safety or effectiveness." |
2. Sample Size for the Test Set and Data Provenance:
- Not Applicable. This submission relies on a non-clinical "mathematical mechanical analysis" rather than a clinical "test set" with human or animal subjects. Therefore, there's no sample size or data provenance in the context of clinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. No clinical test set or human-based ground truth establishment is described. The assessment is based on engineering analysis.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no clinical test set, there is no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document does not mention an MRMC comparative effectiveness study. It's a submission for a mechanical implant, not a diagnostic or AI-driven imaging device.
6. Standalone (Algorithm Only) Performance Study:
- No. This is not an AI-driven device or algorithm. The submission pertains to a physical implant.
7. Type of Ground Truth Used:
- The "ground truth" here is the performance of the predicate device as established through its existing regulatory clearance and assumed safety and effectiveness. The new device demonstrates "substantial equivalence" based on similar materials, indications, dimensions, geometry, and non-clinical mechanical testing that shows it doesn't present a "new worst case."
8. Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set exists for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes a non-clinical study involving mathematical mechanical analysis related to static bend testing. This analysis was conducted to compare the new PRO-TOE® Hammertoe Fixation System implants (specifically the PRO-TOE® VO Cannulated and PRO-TOE® C2 implants) against their legally marketed predicate device (K101165 – PRO-TOE™ VO Hammertoe Implant System and K120645 - PRO-TOE™ Hammertoe Implant System).
The purpose of this study was to demonstrate that the mechanical properties of the subject implants, in terms of static bending, do not present a new worst case compared to the predicate devices. This finding, along with the similarities in indications, materials (stainless steel or titanium), dimensions, and geometry, allowed Wright Medical Technology, Inc. to conclude that the device is substantially equivalent to the predicate devices and does not raise new questions of safety or effectiveness. No human or animal subjects were involved in this specific study.
§ 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.