(85 days)
The PHALINX® Hammertoe System 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 PHALINX® Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The PHALINX® Hammertoe System implants are a single piece titanium device offered in straight cannulated and 10° solid options. The implants have proximal and distal fixation features and are offered in multiple sizes. This submission seeks to add PHALINX® K-Wires to the system for use with cannulated implants. The PHALINX® 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.
This document is a 510(k) premarket notification for a medical device called the "PHALINX® Hammertoe System." It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria as would be expected for an AI/software as a medical device (SaMD).
This document is for a physical orthopedic implant system, not a software or AI device. Therefore, the requested information categories regarding acceptance criteria, performance studies, sample sizes, ground truth, experts, and MRMC studies, which are typical for SaMD, are not applicable here.
The document primarily focuses on establishing "substantial equivalence" to predicate physical devices, meaning it is similar enough in design, materials, and intended use that it does not raise new questions of safety or effectiveness.
Here's a breakdown of what is available in the document, framed against your request, to highlight the absence of SaMD-specific information:
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A table of acceptance criteria and the reported device performance:
- Not applicable / Not present. This submission does not provide acceptance criteria for a performance study as might be done for SaMD. Instead, it relies on substantial equivalence.
- The document states: "Testing related to bending and pull-out strength was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical." This implies that the current device is considered to meet the same performance characteristics as its predicates based on its identical design.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not present. There is no "test set" in the context of an AI/software evaluation.
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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 / Not present. "Ground truth" in the context of an AI/software evaluation is not relevant for this physical device submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not present.
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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 / Not present. MRMC studies are specific to evaluating AI in diagnostic contexts.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not present. This is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not present.
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The sample size for the training set:
- Not applicable / Not present. No "training set" for an algorithm.
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How the ground truth for the training set was established:
- Not applicable / Not present.
Summary of Device and its Basis for Clearance:
- Device Name: PHALINX® Hammertoe System
- Intended Use: Fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants can be used with K-wires for delivery or temporary stabilization of outlying joints.
- Device Description: Single-piece titanium device (straight cannulated and 10° solid options) with proximal and distal fixation features, offered in multiple sizes. This submission specifically adds PHALINX® K-Wires (surgical grade stainless steel) for use with cannulated implants.
- Basis for Clearance (Substantial Equivalence): The device design is stated to be "identical to the currently marketed PHALINX® Hammertoe System." Therefore, new performance testing (like bending and pull-out strength) was not provided, as it was previously submitted for the predicate device.
- Clinical Evidence: "N/A" (Not Applicable)
- Conclusion: The design characteristics "do not raise any new types of questions of safety or effectiveness." The device is expected to perform "at least as well as the predicate device."
§ 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.