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The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

The Orbit Subretinal Delivery System (SDS) is comprised of 3 primary component sets including the Subretinal Injection Device Set, the Tubing Set, and the Dosing Set. Each Orbit SDS Set contains sterile single-use only components. The Subretinal Injection Device set includes the magnetic pad, ophthalmic marker, and subretinal injection device (SID). The Tubing Set includes the components for priming the BSS line and pneumatic BSS control via a vitreoretinal surgical console. The Dosing Set includes the syringe for delivery of a precise dose of Balanced Salt Solution (BSS) or BSS PLUS® infusate.

I am sorry, but the provided text is a 510(k) summary for a medical device called the "Orbit Subretinal Delivery System." This document focuses on demonstrating substantial equivalence to a predicate device and outlines various performance tests conducted.

However, it does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set for an AI/ML model.
9. How the ground truth for the training set was established for an AI/ML model.

The document describes performance data related to biocompatibility, sterilization, packaging, shelf life, and simulated use for a physical medical delivery system, not an AI/ML algorithm.

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The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

The Orbit Subretinal Delivery System is designed for microinjection into the subretinal space. The Orbit Subretinal Delivery System is comprised of 2 kits: the Subretinal Access Kit and the Third Arm Kit. All Subretinal Access Kit components are supplied sterile and intended for single-use only and cannot be reused or resterilized. The Subretinal Access Kit contains the following device components: Subretinal Injection Cannula, Ophthalmic Marker, Syringes, and Tubing Set. The assembled Third Arm Kit functions as a "third arm" to stabilize the subretinal injection cannula and free the surgeon's hands during the procedure. The Third Arm Kit (supplied nonsterile) is reusable and must be cleaned and sterilized prior to each use. Together, the Subretinal Access Kit and the Third Arm Kit are to deliver the infusate (e.g., BSS. BSS® PLUS) to the subretinal space as described in the Instructions for Use.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Simulated use evaluation: Eight (8) procedures were conducted in a porcine model.
  • Specific sample sizes for other tests (e.g., biocompatibility, sterilization, packaging) are not detailed in the provided document. The document states "Testing demonstrated product performance met all prior established acceptance criteria," implying that adequate samples were used for these regulatory tests, but the numbers themselves are not specified.
• Data Provenance: The simulated use test was performed in a porcine model, indicating animal testing. The document does not specify the country of origin for the data, nor does it explicitly state whether it was retrospective or prospective. Given the nature of medical device validation testing, it would generally be prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document describes laboratory and animal model testing, not human clinical studies involving expert observers to establish ground truth in the way one might for diagnostic AI.
• For the simulated use evaluation, the procedures were performed in a porcine model. It is implied that qualified personnel (e.g., surgeons, researchers) carried out these procedures and observed the results (formation of subretinal blebs), but the number and specific qualifications of these individuals are not stated.

4. Adjudication Method for the Test Set

• The document describes engineering and simulated use testing, not a scenario where human observers would require an adjudication method for ground truth. Observations from the simulated use evaluation (formation of subretinal blebs) are presumably directly observable outcomes rather than requiring expert consensus. Therefore, an adjudication method in the context of expert consensus is not applicable/described.

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

• No, an MRMC comparative effectiveness study was not done. The Orbit Subretinal Delivery System is a physical medical device (a microinjection system), not an AI algorithm or a diagnostic tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a manual ophthalmic surgical instrument designed for human operators; it is not an algorithm, and therefore, standalone algorithmic performance is not relevant.

7. The Type of Ground Truth Used

• For the simulated use evaluation, the "ground truth" was the direct observation of the physical outcome: the successful formation of a subretinal bleb after injection into a porcine model.
• For other tests like biocompatibility, sterilization, and performance testing, the ground truth refers to established scientific and regulatory standards (e.g., ISO standards, FDA guidance, pre-established test criteria) that define acceptable performance.

8. The Sample Size for the Training Set

• Not applicable. The Orbit Subretinal Delivery System is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, this is not an AI model requiring a training set.

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