(24 days)
The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK or titanium alloy implant and a set of instruments used for implant site preparation and delivery. The device is offered in extra small, small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.
This document describes a medical device called the HammerFiX Device, which is a bone fixation fastener used in foot surgery. It is a 510(k) premarket notification, which means it builds upon an already approved predicate device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a standalone study with acceptance criteria for a novel device.
Based on the provided document, the following information can be extracted:
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Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states "No clinical testing was performed." and that "Bench testing, including pull-out, torque and bending was performed and compared to the predicate device." However, no specific acceptance criteria (e.g., minimum pull-out strength, maximum bending angle) or reported numerical performance values for this bench testing are provided in the summary. The conclusion simply states that the new device and predicate device are equivalent based on this testing.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| (Not explicitly stated for the device in this summary) | Performance was similar to the predicate device in pull-out, torque, and bending tests. | The document does not provide specific numerical values for acceptance criteria or performance for these bench tests. It only states that the new device was compared to the predicate device. |
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No clinical testing was performed, and the sample sizes for the bench testing are not provided.
- Data Provenance: Not applicable for clinical data. For bench testing, the provenance is that the tests were performed by the manufacturer, Extremity Medical, LLC.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. No clinical testing was performed, thus no ground truth was established by experts for a test set in the context of this 510(k) submission.
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Adjudication Method for the Test Set:
Not applicable. No clinical testing was performed.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states "No clinical testing was performed."
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a medical implant device, not an algorithm.
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Type of Ground Truth Used:
Not applicable. No clinical testing was performed. For the non-clinical testing, the "ground truth" would be the measured mechanical properties of the predicate device against which the new device was compared.
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Sample Size for the Training Set:
Not applicable. This is a medical implant device, and no algorithm with a training set is involved.
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How the Ground Truth for the Training Set Was Established:
Not applicable. No algorithm with a training set is involved.
Summary of Device Rationale from the Document:
The HammerFiX Device is a PEEK or titanium alloy implant used for fixation of osteotomies and reconstruction of lesser toes. The current submission, K152710, is a "Special 510(k)." This typically means that the device is a modification of an already cleared predicate device (K133636 - HammerFiX by Extremity Medical). The manufacturer asserts substantial equivalence based on:
- Identical indications for use.
- Similar design.
- Similar material mechanical properties.
- Bench testing (pull-out, torque, and bending) which showed equivalence to the predicate device.
- No clinical testing was deemed necessary for this 510(k) submission because it is demonstrating substantial equivalence to an existing, cleared 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.