(28 days)
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrates substantial equivalence to the Taras Threaded Fixation Pin (K032532). This involves a comparison of technological characteristics and mechanical performance. | "The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pins that are legally marketed and distributed by Union Surgical, LLC. This has been demonstrated through a 13-point technological comparison of features and a 3-parameter comparison of mechanical performance." |
| Material Standards | Compliance with ASTM F138 - 97: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). Compliance with ASTM F899 - 95: Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical. | The device "complies with the following standards... ASTM F138 - 97" and "ASTM F899 - 95". The materials "have a long history of safe usage in medical devices." |
| Device Design/Function Standards | Compliance with ASTM F366 - 82 (Reapproved 2000): Standard Specification for Fixation Pins and Wires. | The device "complies with the following standards... ASTM F366 - 82 (Reapproved 2000)". The device is a "threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures," similar to the predicate. |
| Safety and Effectiveness | The device is safe and effective and performs as well as, or better than, the predicate device. | "Since the Union Surgical, LLC T-Pin® meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as, or better than, the predicate device." "The T-Pin® will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use." The FDA's 510(k) clearance confirms this determination. |
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.
-
A table of acceptance criteria and the reported device performance: (See table above)
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.
§ 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.