(68 days)
The Union Surgical, LLC Threaded Fixation Pins are intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.
The Union Surgical, LLC Taras Threaded Fixation Pins are threaded stainless steel Steinmann pins used for the repair of wrist fractures. The device incorporates a break-off shank. The device is optionally supplied with removal tools that permit pin extraction.
The provided text describes a 510(k) premarket notification for a medical device, the Taras Threaded Fixation Pin. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria and performance metrics typically seen in studies for novel, higher-risk devices or AI-powered diagnostics.
Therefore, the information requested in your prompt related to acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details is not present in the provided document.
Here’s a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics with thresholds. The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to a predicate device. This is achieved through:
- Comparison of technological characteristics.
- Comparison of mechanical performance.
- Compliance with recognized standards.
- Reported Device Performance:
Aspect Reported Performance/Basis of Equivalence Technological Characteristics Found to be substantially equivalent to the Zimmer Threaded Steinmann Pin through a 12-point comparison of features. Mechanical Performance Found to be substantially equivalent to the Zimmer Threaded Steinmann Pin through a 3-parameter comparison. Standards Compliance Complies with:
- ASTM F366 - 82 (Reapproved 2000), Standard Specification for Fixation Pins and Wires
- ASTM F138 - 97, Standard Specification for Wrought 18 Chromium-14Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- ASTM F899 - 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical |
| Material Safety | Implantable and tissue contact materials have a "long history of safe usage in medical devices." |
2. Sample sized used for the test set and the data provenance
- This information is not provided. The submission relies on technological and mechanical comparisons, and compliance with standards, rather than clinical test sets with data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to this type of marketing submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. Not applicable to this type of submission.
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 MRMC study was done. This device is a physical fixation pin, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a physical fixation pin, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The concept of "ground truth" from these categories is not applicable to this submission. The "truth" for this submission is whether the device is "substantially equivalent" to a predicate device based on its design, materials, and mechanical properties, and whether it complies with relevant engineering standards.
8. The sample size for the training set
- This information is not provided. A "training set" is not relevant for this type of medical device submission.
9. How the ground truth for the training set was established
- This information is not provided. Not relevant for this type of medical device submission.
In summary: The provided document is a 510(k) submission primarily demonstrating "substantial equivalence" of a physical medical device (Taras Threaded Fixation Pin) to a legally marketed predicate device (Zimmer Threaded Steinmann Pin). The evaluation relies on comparisons of technological characteristics, mechanical performance, and adherence to established engineering standards, rather than clinical studies with test sets, expert consensus, or performance metrics typical of diagnostic or AI-powered devices.
§ 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.