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The Choy Compression Frame is indicated as an accessory for axial compression of the lumbar spine in CT and MR diagnostic imaging.

The Choy Compression Frame consists of a fabric shoulder harness with straps and an MRI-compatible aluminum frame assembly with pneumatic pump. The pneumatic pump operates to apply a force to the patient and thus raise the patient's intradiscal pressure.

Here's an analysis of the provided text regarding the Choy Compression Frame, focusing on acceptance criteria and the study details:

Device: Choy Compression Frame
K Number: K070968

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that clinical testing demonstrated these two points, implying they were the key criteria for determining effectiveness and safety. There are no numerical thresholds or specific metrics provided for these criteria in the document.

Study Details

The provided document offers limited details regarding the specifics of the clinical study.

1. Sample Sized Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "clinical testing."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not specified. The document refers to "MR diagnoses" and "MR findings" but doesn't detail how the ground truth for these was established or by whom.

3. Adjudication Method for the Test Set:

• Not specified.

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

• No. The document describes the device's performance in terms of increasing sensitivity of MR diagnoses, but it does not present a comparative effectiveness study involving human readers with and without AI assistance (as this is a mechanical compression frame, not an AI device).

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable, as this is a medical device for physical compression, not a diagnostic algorithm or AI. The "performance data" refers to the device's functional impact on imaging.

6. Type of Ground Truth Used:

• The ground truth appears to be based on "presenting symptoms" matched with "MR findings." This suggests a clinical correlation approach, likely interpreted by medical professionals, although the exact method (e.g., expert consensus, comparison to a gold standard like surgical findings or pathology) is not detailed.

7. Sample Size for the Training Set:

• Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable, for the same reason as above.

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