(57 days)
Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.
The SIGN Compression Screw System consists of multiple components; self-tapping compression screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided nonsterile.
The provided document is a 510(k) summary for the SIGN Compression Screw System. It describes the device, its intended use, and a comparison to predicate devices, particularly the ASNIS III Cannulated Screw System (K000080).
Please Note: The document focuses on demonstrating substantial equivalence based on design, materials, and mechanical performance testing. It does not contain information about acceptance criteria for a diagnostic AI device, nor does it describe a study involving human readers, AI assistance, or the creation of ground truth for a diagnostic algorithm.
Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of device (a medical implant, not an AI or diagnostic tool) and a different type of regulatory submission (substantial equivalence for a physical medical device, not performance validation for an AI algorithm).
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided in the context of an AI device. This document describes mechanical testing for a medical implant. The "acceptance criteria" here are implicitly that the device performs equivalently or better than the predicate in terms of mechanical characteristics.
- Reported Device Performance (from "Performance Data (non-clinical)"):
- Axial stiffness
- Load to failure
- Cyclic fatigue
- Outcome: "The results support substantial equivalence and did not raise any issues on the safety or effectiveness of the device."
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. This document describes mechanical testing of a medical device, not an AI algorithm evaluated on a data set. Therefore, there is no "test set" in the context of diagnostic images or data, nor provenance information for such data.
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. This information is for an AI/diagnostic device. The "ground truth" for the mechanical testing would be the physical measurements of the screws themselves, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information is for an AI/diagnostic device.
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
- No. A MRMC study was not done. This study solely focused on the mechanical performance of the physical screws.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This information is for an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of an AI device. For the mechanical testing, the "ground truth" would be the objective physical measurements performed according to established test standards (e.g., ASTM F138).
8. The sample size for the training set
- Not applicable. This document describes mechanical testing of a physical device, not an AI algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is mentioned.
Summary regarding AI aspects:
The provided document is a 510(k) summary for a physical medical implant (SIGN Compression Screw System). It details the device's design, intended use, materials, and non-clinical mechanical performance testing to demonstrate substantial equivalence to predicate devices. It does not contain any information related to AI devices, diagnostic algorithms, or their acceptance criteria or study methodologies. Therefore, most of your questions, which are framed for AI/diagnostic devices, cannot be answered from this text.
§ 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.