(137 days)
The compressive osteosynthesis staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Compressive osteosynthesis staples are single-use bone fixation appliances intended to be permanently implanted. ARCAD osteosynthesis staples are bipodal compression staples made of shape memory nickel titanium alloy.
The provided text describes a 510(k) summary for the ARCAD and EXPRESS Compressive Osteosynthesis Staples. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device's performance against specific acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of a new, AI-driven diagnostic or therapeutic device is not directly available in this submission.
This 510(k) submission primarily relies on comparisons of material, design, and mechanical characteristics to a legally marketed predicate device.
Here's an analysis based on the information provided, highlighting what is and is not present concerning the acceptance criteria and study proving device performance:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria (Implicit): For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence (SE) to a predicate device. This involves showing that the new device has similar technological characteristics (material, design, mechanical properties) and intended use, and that any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance (Implicit): The performance is demonstrated by showing compliance with relevant industry standards and successful mechanical testing that mirrors the predicate.
| Criteria Category (Implied for 510(k) SE) | Reported Device Performance (from text) |
|---|---|
| Material Compatibility | The ARCAD/EXPRESS staples are made of shape memory nickel-titanium alloy, complying with ASTM F2063-12 (Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). |
| Mechanical Characteristics | Similar technological characteristics in terms of design and mechanical characteristics (static bending, dynamic bending and pull-out resistance). Compliance with ASTM F564-10 Sections A1, A2, and A4 (Standard Specification and Test Methods for Metallic Bone Staples) is implicitly met through comparison with the predicate. |
| Biocompatibility | Conducted in accordance with Blue Book Memorandum #G95-1 and International Standard ISO 10993-1. |
| Intended Use | Same as predicate: Hand and foot bone fragments osteotomy fixation and joint arthrodesis. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission does not describe a "test set" in the context of clinical or diagnostic performance. Instead, it refers to mechanical testing of the staple devices themselves. The specific number of devices tested for static bending, dynamic bending, and pull-out resistance is not detailed.
- The provenance of data would be from laboratory mechanical testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the sense of expert medical review for diagnostic accuracy or outcomes is not relevant for this type of device and submission. The "ground truth" for mechanical performance is established by the specifications of the ASTM standards and the measurements taken during mechanical testing.
4. Adjudication method for the test set:
- Not applicable. There is no adjudication method described as there isn't a "test set" requiring expert consensus.
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 a surgical implant (staple) and does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For this 510(k) submission, the "ground truth" for device performance is primarily based on engineering standards and mechanical testing results, demonstrating that the device meets the specifications outlined in ASTM F2063-12 (material) and ASTM F564-10 Sections A1, A2, A4 (mechanical properties). The biocompatibility "ground truth" is established by compliance with ISO 10993-1.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a "training set."
In summary: The provided document is a 510(k) premarket notification for a medical device (surgical staples). The regulatory pathway for this type of device typically involves demonstrating substantial equivalence to a predicate device through engineering and performance testing against recognized standards, rather than clinical trials with specific acceptance criteria as you might see for a novel diagnostic or therapeutic product seeking its own performance claims. Therefore, many of the questions related to AI/algorithm performance and clinical study designs are not applicable to this submission.
§ 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.