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The Inflatable Positioning Cushion device is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion device allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

The Inflatable Positioning Cushion is designed to be used on a standard nuclear imaging table with cradle dimensions of 80" long by 14" wide, such as the SPECT Table manufactured by Medical Imaging Electronics. The Inflatable Positioning Cushion is comprised of a Head Section and Abdominal Section, containing foam cushions and inflatable cushions, and a Lower Body Section of foam cushions. The cushions are secured to the nuclear imaging table with Velcro straps and inflatable straps that wrap underneath the table. The blower for the inflatable cushions is in a separate enclosure that can hang at the end of the nuclear imaging table or sit on the floor.

This is a 510(k) summary for a medical device and therefore does not contain the detailed study information typically found in a standalone clinical study report. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than proving performance against specific acceptance criteria through a dedicated study.

However, based on the provided text, we can infer some information and identify what is missing.

Inferred Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices. The device's performance is described in terms of its intended use and features, positioning it as functionally equivalent to the predicates.

Missing Information (Commonly found in detailed study reports):

The provided text does not contain the following detailed study information typically associated with a robust performance evaluation against specific acceptance criteria for AI/diagnostic devices:

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

   • Missing. There is no specific test set or data mentioned for the subject device. The clearance is based on substantial equivalence to existing devices.

2. 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):

   • Missing. This type of evaluation is not relevant for a physical positioning device.

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

   • Missing. Not relevant for this type of device.

4. 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:

   • Missing. This is a physical support device, not an AI or diagnostic imaging device that involves human readers interpreting results.

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

   • Missing. Not applicable; this is not an algorithm.

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

   • Missing. The "ground truth" for this device would be its ability to physically position a patient comfortably and correctly for scintimammography, and to do so without interfering with image acquisition (e.g., radiolucency). This is evaluated through engineering specifications, material properties, and comparison to predicates, rather than clinical ground truth for a diagnostic outcome.

7. The sample size for the training set:

   • Missing. This is not an AI/machine learning device that requires a training set.

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

   • Missing. Not applicable.

Crucial Point: This 510(k) submission is for an "Inflatable Positioning Cushion," a relatively low-risk physical accessory. The FDA's 510(k) process for such devices relies heavily on demonstrating substantial equivalence to predicate devices already on the market, rather than requiring extensive clinical trials with specific performance endpoints like those for new diagnostic or therapeutic technologies. The "study" mentioned for the predicate device (Scintimammography Prone Breast Cushion) was a clinical study on the technique of scintimammography itself and the efficacy of that predicate cushion in the detection of breast cancer, not a study specifically on the acceptance criteria of the new inflatable cushion alone. Therefore, the information you're looking for regarding concrete performance metrics and detailed study designs is not typically part of such a 510(k) substantial equivalence submission for this type of device.

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