(427 days)
The Mediscope Asymmetrical Compression Staple is intended to be used for fixation such as: mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Mediscope Compression Staple is a single patient use device made of surgical grade The Medisope Oompression Stapie is cross the fusion site of two bones from the adiacent position. The design features of the Mediscope Compression Staple are summarized below: - Manufactured from nickel-free stainless steel . - 5 sizes . - Barbs to prevent back out .
The provided text describes a medical device, the "Mediscope Asymmetrical Compression Staple and Accessories," and outlines its submission for 510(k) clearance. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would typically be described for software or AI-based medical devices (e.g., sensitivity, specificity, accuracy against a ground truth dataset).
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Wright Medical Compression Staple and Simple Staple, K043059) through engineering testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't define specific "acceptance criteria" for metrics like sensitivity, specificity, or accuracy, because it's not evaluating an AI or diagnostic device in that manner. Instead, the "acceptance criteria" are implied by the performance of the predicate device and the standards followed.
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (Mediscope Staple) |
|---|---|
| Elastic Static Bending (per ASTM F564-02) | Tested to demonstrate substantial equivalence to predicate device. Implies performance comparable to the predicate. |
| Constant Amplitude Bending Fatigue (per ASTM F564-02) | Tested to demonstrate substantial equivalence to predicate device. Implies performance comparable to the predicate. |
| Pull-Out Fixation Strength (per ASTM F564-02) | Tested to demonstrate substantial equivalence to predicate device. Implies performance comparable to the predicate. |
| Biocompatibility (per ISO 10993-1 (2003)(E)) | Testing conducted, implying compliance with biocompatibility standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the engineering tests. ASTM F564-02 (Standard Specification and Test Methods for Metallic Bone Staples) would outline the required sample sizes for these types of mechanical tests.
- Data Provenance: Not applicable in the context of human data. The "data" here refers to mechanical test results of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable. The "ground truth" for a mechanical device is established through physical measurements and adherence to engineering standards (ASTM F564-02) rather than expert human interpretation.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing ground truth, typically in diagnostic imaging or clinical studies. This document describes objective mechanical testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a physical bone staple.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance evaluation (in the context of an algorithm) was not done. This document is for a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical performance of the staple is based on:
- Engineering Standards: Specifically, ASTM F564-02 for mechanical properties (elastic static bending, constant amplitude bending fatigue, pull-out fixation strength).
- Predicate Device Performance: The Mediscope staple's performance in these tests was compared to that of the already cleared predicate device (Wright Medical Compression Staple). Substantial equivalence implies that its performance met or exceeded the predicate's in a way that doesn't raise new questions of safety or effectiveness.
- International Standards: ISO 10993-1 (2003)(E) for biocompatibility.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of this traditional device submission. Training sets are used for machine learning models.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reason as point 8.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical bone staple by comparing its mechanical performance and biocompatibility to a predicate device and relevant engineering standards, rather than evaluating an AI or diagnostic algorithm against clinical performance metrics.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.