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The AccuTread™ Shoe is intended for use as a limb load monitoring device to monitor limited weight bearing during rehabilitation of patients with insults to their lower extremities.

The AccuTread™ Shoe is a shoe-like enclosure, worn by patients having insults to their lower extremities. The device is intended for use to achieve benefits such as:

• protection of the affected extremity during the healing process, .
• . ease of mind during initial ambulation, and
• documentation of compliance or non-compliance to a prescribed weight ● bearing program.
  These benefits derive from the patient's ability to know that he/she is not exceeding the correct amount of weight applied to the affected extremity as prescribed by their physician. The complete device consists of the following components:
• Shoe Body .
• Sensor Unit
• Transmitter .
• . Receiver

Here's a breakdown of the acceptance criteria and study information for the AccuTread™ Shoe, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain a formal "acceptance criteria" section with specific quantitative targets and results from a clinical study in the way a clinical trial report would. Instead, it highlights the device's technical specifications and how they compare to the predicate, with inherent performance claims embedded in the specifications, particularly in the "Precision" and "Load Sensitivity" sections.

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

This information is not provided in the given 510(k) summary. 510(k) submissions for devices like this, particularly in 1996 for a Class II device, often relied on bench testing and comparisons to predicate devices rather than extensive clinical studies with human participants. The document primarily describes the device's design and compares its features to the predicate.

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 in the given 510(k) summary. Ground truth establishment with experts is typically part of a clinical validation study, which is not detailed here.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary. Adjudication methods are relevant to studies involving human interpretation or performance evaluation, which is not the focus of this document.

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

This information is not applicable/provided in the given 510(k) summary, as it describes a mechanical limb load monitor, not an AI-powered diagnostic imaging device that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/provided in the given 510(k) summary. The AccuTread™ Shoe is a physical device that provides feedback to a human user, not a standalone algorithm. Its performance is inherent in its measurement and alert capabilities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a device like the AccuTread™ Shoe, the "ground truth" would typically refer to the actual applied weight measured by a highly accurate (e.g., laboratory-grade) force sensor against which the device's readings are compared. This is implied by the "Precision" specification. The document speaks to its technical performance and comparison to a predicate, not clinical outcomes in the sense of pathology or long-term patient data.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. The AccuTread™ Shoe is a physical measurement and alert device, not a machine learning model that would require a "training set" in the conventional sense. Its calibration process is likely based on engineering principles and bench testing.

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

This information is not provided and is not applicable as the device is not an AI/ML model requiring a training set in the conventional sense. The "ground truth" for its calibration and precision would be established through physical force measurements on test equipment.

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