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The Union Surqical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

The Union Surgical. LLC T-Pin® is a threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures. The device incorporates a break-off shank. The device is ontionally supplied with removal tools that permit pin extraction and a sterilization tray.

The Union Surgical, LLC T-Pin® is a cannulated fixation screw intended for the repair of specific wrist fractures. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as might be found for a novel diagnostic or AI-driven device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The T-Pin®'s acceptance criteria are framed around its substantial equivalence to a legally marketed predicate device and compliance with relevant ASTM standards. These are not performance metrics in the sense of accuracy, sensitivity, or specificity often associated with diagnostic or AI devices, but rather design, material, and mechanical property standards for surgical implants.

Detailed Study Information (Based on the Provided Text):

The provided document describes a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full-scale clinical or performance study with the types of metrics requested for AI or diagnostic devices. Therefore, many of the requested details for a "study" are not applicable or explicitly stated in this context.

1. A table of acceptance criteria and the reported device performance: (See table above)

2. Sample size used for the test set and the data provenance:

   • Not Applicable in this context. For a 510(k) for a fixation pin, a "test set" in the sense of patient data is not used for proving substantial equivalence in the way it would be for an AI algorithm. The "testing" refers to mechanical and material characterization against established standards and comparison to the predicate device's specifications. The document does not specify details of any in vitro mechanical testing beyond stating that a "3-parameter comparison of mechanical performance" was done, and it doesn't mention the specifics of that comparison or sample sizes for such tests.
   • Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. Ground truth in the context of expert review of patient cases is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and comparison to a predicate device, which is evaluated by regulatory bodies and engineers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods are used to establish consensus among experts for ground truth in clinical data; this is not relevant for a device cleared through substantial equivalence based on technical specifications and material standards.

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. An MRMC comparative effectiveness study is not mentioned and would not be relevant for a bone fixation pin. This device is 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 is a physical medical device (a surgical pin), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this submission revolves around compliance with established engineering and material standards (e.g., ASTM F366, F138, F899) and demonstrated equivalence in technological characteristics and mechanical performance to a legally marketed predicate device (Taras Threaded Fixation Pin K032532). Physical and material properties are the "truth" being assessed.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" as 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.

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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.

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