(103 days)
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.
The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250".
The provided text is a 510(k) submission for a medical device called "TriMed tension band sleds" (also referred to as "Tension Band Wire"). This document outlines the device's description, intended use, and technological characteristics, and includes the FDA's letter of substantial equivalence.
However, a 510(k) submission for this type of device (a bone fixation fastener) does not typically include detailed studies proving performance against specific acceptance criteria in the way that, for instance, an AI/ML software device would. The FDA's substantial equivalence determination for such a device is primarily based on showing that it is as safe and effective as a legally marketed predicate device, rather than on extensive clinical trials with specific performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided document because they are generally not required or part of a 510(k) submission for this class of device. The primary "study" is the comparison to predicate devices, which the document implicitly covers by stating the device has "identical characteristics to existing pins and wires commonly in use."
Here's a breakdown based on the information available and not available in the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable/Not Provided. The document is a 510(k) submission for a mechanical implant (tension band wire). The acceptance criteria for such a device are primarily related to material specifications, dimensional characteristics, and an overall demonstration of substantial equivalence to existing predicate devices in terms of safety and efficacy for its intended use. There are no specific numerical performance metrics (like sensitivity, specificity, or accuracy) reported that would typically be found for a diagnostic or AI/ML device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Provided. This information pertains to studies typically conducted for AI/ML or diagnostic devices. For a mechanical implant, testing might include mechanical strength tests or biocompatibility tests, but these are not described in the terms of a "test set" as requested here. The "data provenance" for a material or mechanical device usually refers to where the materials were sourced or manufactured, not clinical data sets.
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/Not Provided. This is relevant for diagnostic performance studies. The "ground truth" for a bone fixation device is its ability to physically hold bone fragments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. This applies to methods for resolving discrepancies in expert interpretations, common in diagnostic imaging studies.
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/Not Provided. MRMC studies are associated with evaluating the performance of diagnostic imaging devices or AI-assisted diagnostic tools. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Provided. This concept is only applicable to AI/ML algorithms. The device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device's performance would be clinical outcomes related to fracture healing and stability, as well as mechanical testing results to ensure its structural integrity. These are not detailed in the provided 510(k) summary. The summary itself relies on the "substantially equivalent" principle to predicate devices, implying similar safety and efficacy without explicitly detailing new "ground truth" studies.
8. The sample size for the training set:
- Not Applicable/Not Provided. This is relevant for AI/ML model development.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. This is relevant for AI/ML model development.
Summary of Device and Basis for Marketing:
- Device: TriMed tension band sleds (tension band wire forms)
- Intended Use: Aid to fracture healing by stabilizing bone fragments until healing occurs, used in conjunction with screws, washers, and/or plates of the same material. Applicable to fractures amenable to tension band wiring.
- Technological Characteristics: Described as having "identical characteristics to existing pins and wires commonly in use."
- Basis for Acceptance: Substantial equivalence to predicate devices (TriMed small fragment clamp and buttress pin, Smith and Nephew Kirschner wires and Steinman pins, Zimmer Kirschner wires and Steinman pins). The FDA granted 510(k) clearance based on this demonstration of substantial equivalence, as stated in the letter dated June 6, 2001. This means the FDA determined the device is as safe and effective as devices already on the market without requiring new clinical trials that would generate performance metrics or refer to "test sets" or "ground truth" in the manner requested.
§ 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.