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The Acumed Ankle Syndesmosis Repair System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma.

The Acumed Ankle Syndesmosis Repair System contains a fibula button, a tibia button and a high strength fiber suture assembled onto a driver, and is provided in a sterile kit as two options, one with and one without a drill. The system also offers optional washers in a separate sterile kit. The driver and drill are part of the sterile kits and are not available individually.

The metal implants including the buttons and washers are manufactured from Titanium Alloy (Ti 6AL-4V ELI per ASTM F136) and the suture is manufactured from ultra-high-molecular-weight polyethylene (UHMWPE).

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets these criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device (Acumed Ankle Syndesmosis Repair System).

While it mentions that non-clinical bench testing was conducted to demonstrate substantial equivalence to a predicate device, it does not provide:

• A table of acceptance criteria and reported device performance. It only states that static and dynamic fatigue testing was conducted and that the system performs "statistically equivalent" to the predicate. No specific performance metrics or acceptance thresholds are given.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• If an MRMC comparative effectiveness study was done or its effect size.
• If a standalone performance (algorithm only) was done.
• The type of ground truth used. (This device is a hardware implant, not an AI/software device, so the concept of ground truth in the context of expert consensus or pathology is not applicable here).
• Sample size for the training set. (Again, not applicable for a hardware device unless referring to development iterations, which are not detailed).
• How ground truth for the training set was established. (Not applicable).

The document mentions that "Clinical testing was not required to support substantial equivalence," which further indicates that the detailed study information you are asking for, especially related to human readers or ground truth derived from clinical data, would not be present in this submission type.

In summary, the provided text details the regulatory clearance of a physical medical device based on substantial equivalence to a predicate device through non-clinical bench testing, not an AI/software-based diagnosis or image analysis system that would typically involve the detailed study characteristics you've requested.

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The Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.

The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under K160069. It is a stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and instrumentation required for the fixation of fibula fractures and osteotomies.

The provided text describes the Arthrex FibuLock Nail, its predicate device, and the basis for its 510(k) clearance. However, it does not contain information related to acceptance criteria, human reader studies (MRMC), standalone algorithm performance, or ground truth establishment for a study proving device performance in the context of AI/ML.

The "Performance Data" section briefly mentions "Worst-Case Cross-Section Comparison" and "Axial pullout and torsion comparison testing," which are mechanical performance tests typical for orthopedic implants, not studies involving AI or human readers for diagnostic tasks.

Therefore, many of the requested details, particularly those pertaining to AI/ML device evaluation, cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Test Set Sample Size: Not applicable. This document describes mechanical testing for an orthopedic implant, not a study with a "test set" of patient data for diagnostic or predictive purposes.
• Data Provenance: Not applicable. The "data" refers to mechanical test results, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert diagnosis, pathology) is not relevant for the mechanical testing described.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. This document does not mention any MRMC studies or human reader performance.

6. If a standalone (algorithm only) performance study was done:

• No. This document describes a physical medical device (an intramedullary nail), not an algorithm or AI system.

7. The type of ground truth used:

• Not applicable. The relevant "ground truth" for this device would be its mechanical properties meeting engineering specifications, which is assessed through direct mechanical testing, not expert consensus or histopathology.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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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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