(238 days)
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
The provided text describes the 510(k) premarket notification for the Memodyn Staple, a metallic bone fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria in the context of an AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this document. However, I can extract information related to the device's characteristics and the non-clinical testing performed.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative format for specific clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and showing the subject device performs similarly in non-clinical tests.
| Device Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material | Must be ASTM F2063-12 Nitinol alloy, biocompatible and identical to predicate. | Made of Nitinol alloy ASTM F2063-12. All materials are biocompatible and identical to the predicate. |
| Overall Length | 8 – 20 mm | 8 – 20 mm |
| Staple Bridge/Top Width | 8 – 20 mm | 8 – 20 mm |
| OD of Staple | 1.7mm | 1.7mm |
| Static Four Point Bending | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included staple static four point bending. |
| Dynamic Four Point Bending (Fatigue) | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included dynamic four point bending (fatigue). |
| Elastic Compression Distribution of the Legs | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included elastic compression distribution of the legs. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not stated. The "test set" here refers to the physical samples of the Memodyn Staple used for the non-clinical performance evaluation.
- Data provenance: Not explicitly stated. The tests were performed "per ASTM F2063," implying standard laboratory testing methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For a medical device like a bone staple, "ground truth" is typically defined by engineering specifications, material properties, and in vitro performance tests, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically used for assessing disagreements among human readers or evaluators, which is not relevant for the non-clinical mechanical testing 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 is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's evaluation is based on engineering standards and material specifications outlined in ASTM F2063 and comparison to the predicate device's established performance. This is a technical and performance specification ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
§ 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.