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The TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

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The provided text is a 510(k) premarket notification for a medical device called "TRACTION SYSTEM, DIGIT-TRAC 930." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study to establish safety and effectiveness from scratch.

Therefore, the document does not contain information about acceptance criteria, clinical studies with sample sizes, expert ground truth, or AI performance metrics as it would for a novel AI/software medical device.

Instead, the "study" proving the device meets acceptance criteria in this context refers to the comparison of the new device to predicate devices and adherence to electrical safety and electromagnetic compatibility (EMC) standards.

Here's the breakdown of the information that can be extracted or reasonably inferred based on the provided text:

1. A table of acceptance criteria and the reported device performance

The following points address the other requested information, noting that most are not applicable to this type of device submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this type of device. This is a hardware device (powered traction equipment), not a software/AI device that would typically have a "test set" of data in the sense of patient images or other clinical records. The "tests" mentioned are technical standards for electrical safety and EMC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth in the context of clinical data for AI/software is not relevant here. The "experts" involved would be electrical engineers and regulatory experts who performed and reviewed the technical standard testing (EN 60601-1 and EN 60601-1-2) and the comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no "test set" of clinical cases requiring adjudication in this submission.

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-powered device, and no MRMC study was conducted or required for this 510(k) clearance.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For this device, "ground truth" relates to compliance with engineering standards and demonstration of similar design and function to established devices. The "ground truth" for the electrical safety and EMC tests is the defined requirements of the EN 60601-1 and EN 60601-1-2 standards.

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no training set as would be used for machine learning.

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

• Not applicable. As there is no training set, this question is irrelevant.

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The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is unloading due to distraction and positioning.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a clearance letter from the FDA for a medical device called "Lordex Power Traction Unit," indicating that it has been deemed substantially equivalent to a predicate device.

The letter discusses:

• Trade Name: Lordex Power Traction Unit
• Regulation Number: 21 CFR 890.5900
• Regulation Name: Power traction equipment
• Regulatory Class: II
• Product Code: ITH
• Indications For Use: Relief from pain for patients suffering with low back pain, including pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs.

However, it does not include any of the following:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Information on experts used to establish ground truth or adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about a standalone algorithm performance study.
• The type of ground truth used in any study.
• Sample size for a training set or how its ground truth was established.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

Ask a specific question about this device