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The external fixation system is a device intended to be used in treatment of bone conditions including limb lengthening, osteotomies, the arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

The external fixation system includes various size components to accommodate various anatomies and injuries. The clamps enable the frame to be coupled to bone by securing the rods and Schanz Screws for the intended use. Components designed for this system are the medium clamp to accept the 8.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length and 5.0mm diameter x 150mm to 200mm lengths), and the large clamp to accept the 11.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length, 5.0mm diameter x 150mm length to 200mm lengths, and 6.0mm diameter x 225mm to 300mm lengths).

The provided 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance: No performance criteria or results are mentioned.
• Sample size used for the test set and data provenance: No test set is described.
• Number of experts used to establish ground truth and their qualifications: Not applicable as no ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone performance study: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No training set is described.
• How the ground truth for the training set was established: Not applicable.

The document states that substantial equivalence is based on the device having the "same intended use, materials, and same technological characteristics as the predicate devices." It explicitly mentions:

"The external fixation system is substantially equivalent to the Technological Characteristics predicate devices with respect to the design, function, and Comparison: material."

And concludes:

"There are no significant differences between the external fixation system and the other devices as listed in the Substantially Equivalent Devices. The external fixation system and the predicate devices have similar design attributes, material, and intended use thus is considered substantially equivalent."

This type of 510(k) submission relies on demonstrating similarity to already legally marketed devices rather than presenting new performance data against specific acceptance criteria.

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Citieffe External Fixator ST.A.R. 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: - Fracture dislocation with ligaments instability; - Comminuted intra-articular fractures; l - Post traumatic reconstruction for joint stiffness. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

Citieffe External Fixator ST.A.R. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device (ST.A.R. 90 F4 External Fixator) and outlines its intended use. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval and indications for use, not performance studies or acceptance criteria.

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The intended use of the external fixation device is the same as that expressed in the predicate device 510k.

The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.

Here's an analysis of the provided text regarding acceptance criteria and study information for the Avanta Orthopaedics External Fixator.

Important Note: The provided document is a 510(k) summary for a medical device (external fixator). 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies in the way an AI/ML device or a novel therapeutic might. Therefore, many of the requested fields related to AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies) will not be applicable to this traditional device submission.

Acceptance Criteria and Device Performance for Avanta Orthopaedics External Fixator

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a substantial equivalence determination based on a comparison to a predicate device, not a specific study proving performance against pre-defined acceptance criteria in a clinical trial sense. The "study" here is essentially the 510(k) submission itself, which argues that the Avanta Orthopaedics External Fixator is as safe and effective as the legally marketed predicate device (EBI/Orthofix K831576).

The key findings from the comparison table (provided in the document) are:

• The Avanta device and the predicate device have similar design characteristics and intended use.
• The primary difference noted is the pin length range, which is 50-90 mm for Avanta compared to 80-160 mm for EBI/Orthofix. Despite this difference, the FDA determined the device to be substantially equivalent, implying that this difference does not raise new questions of safety or effectiveness for the intended use.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a "test set" of data in the context of an AI/ML device. The "test set" in this case would be the Avanta Orthopaedics External Fixator itself, compared against the predicate device's established performance and characteristics. The "provenance" is the device's design and manufacturing specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on medical images) is not relevant for this type of 510(k) submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process as described for AI/ML validation was performed.

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 a traditional medical device, not an AI/ML-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an AI/ML algorithm, which is not what this device is.

7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device (EBI/Orthofix K831576), which has been legally marketed in interstate commerce prior to May 28, 1976, or has been reclassified. This is based on the history of that predicate device's use and regulatory clearances.

8. The Sample Size for the Training Set
Not applicable. No "training set" in the context of AI/ML algorithms was used.

9. How the Ground Truth for the Training Set was Established
Not applicable. No "training set" was used.

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