(82 days)
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The Metasurg subtalar implants are intended for single use only.
The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 6 sizes ranging from 7mm - 12mm in diameter. The implant is used in the treatment of excessive motion of the talus relative to the calcaneus.
This is a 510(k) summary for the Metasurg Subtalar Implant, a metallic bone fixation fastener. The document establishes substantial equivalence to other legally marketed devices and outlines the intended use and device description.
It's important to note that this document states substantial equivalence to legally marketed devices, but does not provide specific acceptance criteria or an analytical study proving the device meets those criteria. The provided text is a regulatory clearance document, not a performance study report.
Therefore, many of the requested details about acceptance criteria, device performance, and study methodology cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not detail specific acceptance criteria for performance (e.g., mechanical strength, wear resistance, biocompatibility thresholds) nor does it report the Metasurg Subtalar Implant's direct performance against such criteria in a test setting. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, which implies the new device is as safe and effective as the predicate, but doesn't necessarily require reporting new performance data against specific, quantifiable acceptance criteria in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This document does not describe any specific test set or clinical study conducted for the Metasurg Subtalar Implant.
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)
- Not applicable. There is no test set or ground truth described in this regulatory clearance document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no test set or adjudication process described.
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. This device is an implant, not an AI-assisted diagnostic tool, and this document does not describe any MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No specific ground truth is mentioned as this is a regulatory submission based on substantial equivalence, not a clinical trial report.
8. The sample size for the training set
- Not applicable. This involves an implant, not a machine learning model with a training set.
9. How the ground truth for the training set was established
- Not applicable. This involves an implant, not a machine learning model, and therefore no training set or its ground truth establishment is discussed.
Summary of Device Information from the Document:
- Device Trade Name: Metasurg Subtalar Implant
- Classification Name: Smooth & threaded metallic bone fixation fasteners (21 CFR 888.3040, Product Code HWC, Class II)
- Common Name: Subtalar Arthrorisis Implant
- Device Description: A one-piece device made of titanium, implanted into the sinus tarsi of the foot. Offered in 6 sizes (7mm - 12mm diameter).
- Intended Usage/Indications for Use: Treatment of the hyperpronated foot and stabilization of the subtalar joint. Designed to block forward, downward, and medial displacement of the talus, allowing normal subtalar joint motion but blocking excessive pronation and its sequela. Intended for single use only.
- Material: Titanium Alloy (Ti-6AL-4V ELI)
- Substantial Equivalence: Documentation was provided to demonstrate substantial equivalence to other legally marketed devices. This is the primary "proof" used for 510(k) clearance, implying the device is as safe and effective as its predicate.
This 510(k) summary focuses on demonstrating that the Metasurg Subtalar Implant is substantially equivalent to devices already on the market. It does not provide detailed performance study data against specific acceptance criteria for the new device itself. Such data would typically be found in engineering testing reports (e.g., for mechanical properties) or clinical study reports, which are not included in this summary.
§ 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.