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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. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder. The Tensyn™ 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.

This document is a 510(k) premarket notification for the Tensyn™ Band, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in an AI/ML device submission.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for Class II devices like the Tensyn™ Band. The "Performance Data" section briefly describes the types of tests performed but does not provide specific acceptance criteria or detailed results.

Therefore, I cannot provide the requested information from the provided text. The document states:

• Performance Data: "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices."

This indicates that mechanical and physical performance tests were conducted to show the new device performs similarly to existing, legally marketed predicate devices, rather than meeting specific pre-defined quantitative acceptance criteria in the context of an AI/ML study.

To directly answer your numbered points based only on the provided text, I must state that the relevant information is not present or applicable in the context of an AI/ML device study:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states testing was performed to assure substantial equivalence, but no specific performance metrics or acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance: Not provided. The performance data refers to mechanical testing, not a clinical test set with human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical fixation device, not an AI/ML diagnostic tool requiring expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. For a mechanical device, "ground truth" would be engineering specifications and validated test methods.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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The Tensyn™ Band is intended to provide fixation during the healing process following a isolated syndesmotic trauma, such as fixation of syndesmosis disruptions).

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

The Tensyn™ Band is a medical device intended for fixation of syndesmosis disruptions during the healing process following isolated syndesmotic trauma. The device's performance was evaluated through various mechanical tests to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for each mechanical test. The data provenance is not explicitly stated in terms of country of origin but is implicitly from Dallen Medical, Inc. The nature of the testing (mechanical tests on the device itself) means it is not retrospective or prospective in the clinical sense, but rather laboratory-based testing on the device prototypes.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for this device's performance is established through mechanical engineering principles and laboratory testing, not expert clinical consensus or interpretation of medical images.

4. Adjudication Method for the Test Set:

Not applicable. As the device evaluation is based on mechanical testing, there is no need for expert adjudication of results in the traditional sense. The results are quantitative measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The Tensyn™ Band is a surgical implant, and its performance is evaluated through mechanical testing.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a mechanical implant and does not involve an algorithm. The performance is the inherent mechanical properties of the device itself.

7. Type of Ground Truth Used:

The ground truth used is based on mechanical engineering principles and physical measurements from laboratory testing. The device's performance is compared against the known performance characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation focuses on the physical properties and mechanical behavior of the device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of medical device.

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