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Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn "M Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.

The provided text, K133858, describes a 510(k) submission for the Tensyn™ Band, a medical device for syndesmosis fixation. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested elements for acceptance criteria and study details for an AI/diagnostic device are not available in the provided text. The submission primarily relies on demonstrating similar technical characteristics and performance through mechanical testing compared to existing predicate devices.

However, I can extract the information that is present and indicate where information is not provided.

Acceptance Criteria and Study for Tensyn™ Band (K133858)

The submission for the Tensyn™ Band focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing, rather than establishing specific diagnostic acceptance criteria or conducting a clinical study with human readers, as would be typical for an AI or diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

• Rotational loading performance
• Cyclic loading performance
• Ultimate load
• Load at 3mm
• Shear test performance | "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices." (Specific numerical performance metrics are not provided in the summary.) |
  | Similar Technical Characteristics:
• Physical characteristics
• Design
• Materials | "The Tensyn™ Band has similar physical and technical characteristics to the predicate devices since all devices achieve fixation through a suture between two metal fasteners." |
  | Intended Use:
• Fixation of syndesmosis disruptions in ankle fractures. | "Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware." |

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

• Sample Size: Not specified. The studies mentioned are mechanical performance tests on the device itself, not a test set of patient data.
• Data Provenance: Not applicable in the context of mechanical testing. The testing would have been conducted in a laboratory setting by Dallen Medical, Inc.

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

• This is not applicable. The "ground truth" for mechanical testing is based on established engineering standards and measurements, not expert clinical interpretation.

4. Adjudication method for the test set

• This is not applicable. Mechanical testing results are objective measurements against predefined 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 was not conducted. This is not an AI or diagnostic device as described in the submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm performance study was not done. This is not an AI device.

7. The type of ground truth used

• The "ground truth" for this device, in the context of demonstrating substantial equivalence, is based on established mechanical engineering test standards and performance of predicate devices. The aim is to show that the Tensyn™ Band performs mechanically in a comparable manner to legally marketed devices for the same intended use.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the sense of machine learning. The design and manufacturing would be based on engineering principles and material science.

9. How the ground truth for the training set was established

• Not applicable. This device does not involve a "training set" for an algorithm.

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