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The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable abdominal retractor consisting of two flexible plastic rings connected by a sleeve of soft, high yield strength, clear plastic film. The internal ring has a circular cross-section (o-ring) and the external ring has a cruciform cross-section (quad-ring). The inner diameter of the internal o-ring limits the radius of abdominal retraction. The diameter of the external quad-ring is the same as the diameter of the internal o-ring and the sleeve. When completely unwound, the height of the cylinder is 10.6 inches. When the quad ring is rolled down, the sleeve is wrapped around the circumference of the ring reducing the height of the sleeve by 1.5 inches per rotation. Because the sleeve film is radially unyielding, the reduction in height causes the radial retraction of the incision site.

The provided text describes a 510(k) summary for the Apple Medical OB/Mobius® Elastic Retractor. This is a medical device submission, not an AI/ML device, and therefore the information typically requested in an acceptance criteria and study description for AI/ML devices (like sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not applicable or present in this document.

The "Testing" section only states: "The Apple Medical OB/Mobius Elastic Retractor has been clinically evaluated for the cesarean section indication and shown to be substantially equivalent to the predicate mechanical abdominal retractors."

Given the information in the document, here's what can be extracted:

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

The document does not explicitly list acceptance criteria in a quantitative or qualitative manner typical for performance metrics. Instead, the basis for approval is "substantial equivalence" to predicate devices. The performance is indirectly described by its intended use and successful clinical evaluation to achieve substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified, other than "clinically evaluated." It does not mention country of origin or whether it was retrospective or prospective.

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 as the device is a physical retractor, not an AI/ML diagnostic tool requiring expert ground truth establishment in the same way. The "clinical evaluation" would likely involve surgeons and medical staff, but specific numbers and qualifications for ground truth are not detailed.

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

• Not applicable/Not specified for this type of device and 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 a physical surgical retractor, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a manual surgical instrument, always used with human involvement.

7. The type of ground truth used:

• Not explicitly defined in terms of "ground truth" as it would be for an AI model. The "clinical evaluation" would have assessed the device's performance against clinical outcomes and the performance of existing predicate devices.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical device.

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