(45 days)
This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates.
This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.
The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Bone Band" device.
Unfortunately, the provided text does not contain information about a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device ("Bone Band"), which primarily focuses on demonstrating substantial equivalence to a predicate device.
Instead of performance criteria and a study demonstrating compliance, the document provides a comparison of the characteristics of the submitted device to a predicate device. This is typical for a 510(k) submission where the primary argument for market clearance is that the new device is as safe and effective as an already legally marketed device, and therefore may not require extensive new clinical or performance studies if the differences are minor.
Therefore, for most of your requested points, the answer will be that the information is not present in the provided text.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Not specified. | Material of construction: Biocompatible Nylon |
| (No specific | Length x Width x Thickness: 17.0 x 0.20 x 0.05 |
| performance | Reuseability: Single Patient Use |
| criteria listed) | Sterility: Sterile |
| Implantation: Non-implantable |
Note: The document states the predicate device is Stainless Steel, reusable, non-sterile. The submitted device has different characteristics in these attributes, but the 510(k) process aims to show these differences do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document does not describe a performance or clinical study; it focuses on a comparison of device characteristics to a predicate device.
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. No test set or ground truth establishment by experts is described for a performance study. The "ground truth" in a 510(k) is implicitly the safety and efficacy of the predicate device, which is already on the market.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is 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 a physical bone band, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone band.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. In the context of a 510(k) substantial equivalence, the "ground truth" is often the established safety and effectiveness of the legally marketed predicate device, rather than a specific ground truth for a new performance study.
8. The sample size for the training set
- Not applicable. No training set is involved for this type of device and submission.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth establishment is described.
In summary: The provided document is a 510(k) summary for a basic orthopedic surgical aid. The primary argument for market clearance is substantial equivalence to an existing predicate device, not the demonstration of performance against specific acceptance criteria through a new study. Therefore, most of the requested information regarding study design, sample sizes, ground truth, and expert evaluation is not present in this type of regulatory 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.