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The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the occular implant to the prosthetic eye.

Titanium nitride coated stainless steel screw, ATTRACTOR SCREW, is designed to be placed into the MEDPOR implant, so that the head of the screw is placed at the anterior appx of the implant as it site in the orbit. The flat head of the screw is flush with the surface of the implant and is covered with the verlying tissue. Magnets of appropriate material, shape, and size to be imbedded into the posterior of the prosthetic eye. The magnets are designed small enough to remain enlinely within the posterior of the prostinents and and any and a belgives onlike the sgrowing force between the imaterial (typically accylic) of the prosthelic eye, and powerful enough to provide a coupling force between th

The provided text describes a 510(k) premarket notification for the MEDPOR Attractor Magnetic Coupling System. It includes information about the device, its indications for use, and a study conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:

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

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. The "Technological Characteristics" section and the study results imply that improved motility and effective coupling were the desired outcomes for the device to be considered beneficial. The statistical significance values (P<0.0001, P=0.02) serve as the "reported device performance" against the implied criterion of improved motility.

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

• Sample Size: The study was conducted on one anophthalmic patient.
• Data Provenance: Not explicitly stated, but given the manufacturer (Porex Surgical, Inc., Newnan, GA) and the FDA submission, it's highly probable the data is from the USA. The study appears to be prospective as it involved an intervention (placement of magnets) and subsequent measurement.

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)

The document does not mention the use of experts to establish a "ground truth" for the motility measurements. The measurements were quantitative and objective (lateral excursion motility).

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

Not applicable. The study involved objective measurements of motility, not subjective assessments requiring adjudication.

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 device is a medical implant system, not an AI or diagnostic imaging device that involves human readers interpreting cases.

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

Not applicable. This device is a physical medical device.

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

The "ground truth" for the effectiveness of the device was measured prosthesis motility (lateral excursion). This is a direct, objective physiological measurement.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning algorithm requiring a training set.

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

Not applicable. This device is not an AI or machine learning algorithm requiring a training set.

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