Search Results

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.

Ask a specific question about this device

The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.

The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.

I apologize, but the provided text from the 510(k) summary (K982931) for the "Threaded Fixation Pin" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

This 510(k) summary is a declaration of substantial equivalence to predicate devices, focusing on the device's intended use and design similarities, rather than detailed performance study results.

Therefore, I cannot populate the requested table or answer the specific questions about studies and data provenance based on this document. The document primarily acts as an FDA clearance letter and an "Indications for Use" statement.

Ask a specific question about this device

Not Found

Threaded Fixation Pin

The provided text is a 510(k) summary for a medical device (Threaded Fixation Pin) from 1996. This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a study report detailing performance data against acceptance criteria.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving a device meets them in the way requested by your prompt.

Here's why and what's missing:

• Acceptance Criteria & Reported Device Performance (1): The document doesn't define any specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, displacement limits) nor does it report any numerical performance results for the Threaded Fixation Pin. It only states its intended use and material.
• Sample Size (Test Set) & Data Provenance (2): There is no mention of a test set, sample sizes, or data provenance as no performance study is described.
• Number/Qualifications of Experts (3): No experts are mentioned in the context of establishing ground truth for a test set.
• Adjudication Method (4): Not applicable as no ground truth establishment process is described.
• MRMC Comparative Effectiveness Study (5): This type of study is not mentioned or implied. The document focuses on material and intended use equivalence.
• Standalone Performance (6): No standalone performance data is presented.
• Type of Ground Truth (7): Not applicable as no ground truth is established for device performance.
• Sample Size (Training Set) (8): No training set is mentioned as no learning algorithm or AI is involved.
• Ground Truth (Training Set) (9): Not applicable.

In summary, the provided text is an equivalence claim for a rudimentary medical device from 1996 and does not contain the kind of detailed study information (especially concerning AI/algorithm performance) that your prompt is looking for.

Ask a specific question about this device