(49 days)
The Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
- Hammer toe deformity
- Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The Metasurg DigiFuse implants are intended for single use only.
The Metasurg DigiFuse Implant is a one-piece threaded device made of titanium intended to be implanted into the medullary bone of the lesser digits. The implant is offered in 4 variations consisting of the combination of 2.0mm and 2.5mm threads and 0° and 10° blades.
The provided text describes a 510(k) summary for the Metasurg DigiFuse Implant and the FDA's decision letter. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and design/dimensional comparisons. It does not contain information about a clinical study with acceptance criteria and device performance as typically expected for advanced diagnostic or AI-driven medical devices.
Therefore, many of the requested elements for a study proving device acceptance criteria cannot be extracted from this specific document.
Here's a breakdown of what can be inferred or is explicitly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable.
This document outlines a regulatory submission based on substantial equivalence to predicate devices, not a clinical study with performance metrics against predefined acceptance criteria. The "acceptance criteria" here are implicitly related to the similarity of intended use, material, and design to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable.
There is no mention of a "test set" in the context of clinical data or image analysis. The comparison is based on the design and dimensional characteristics of the device itself relative to predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable.
No ground truth establishment by experts is described as this is not a study evaluating human or algorithm performance against a known truth.
4. Adjudication Method
Not Applicable.
No adjudication method is relevant as there are no judgments being made by experts on a test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not Applicable.
No MRMC study was conducted or mentioned, as this is a device clearance based on substantial equivalence, not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not Applicable.
This device is an implant, not an algorithm. Therefore, no standalone algorithm performance study was done.
7. Type of Ground Truth Used
Not Applicable.
No ground truth (expert consensus, pathology, outcomes data) was used in the context of a performance study as described here. The "truth" for substantial equivalence is the existing regulatory status and established characteristics of the predicate devices.
8. Sample Size for the Training Set
Not Applicable.
There is no mention of a "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
No ground truth for a training set was established.
Summary of what the document does provide in relation to regulatory acceptance:
- Basis for Acceptance: Substantial equivalence to predicate devices.
- Key Comparison Points: Similar indications, physical dimensions, and material (titanium and/or stainless steel).
- Predicate Devices:
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.