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The ProCare Plus™ Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries.

The PROCARE PLUS™ Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures:
Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis
Removal of lens fragments after cataract surgery;
Remove vitreous traction under the retina producing localized or complete retinal detachment;
Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;
Treatment of vitreous loss during cataract surgery;
Clean vitreous strands from the cataract wound;
Provide internal illumination for vitreous surgery;
Provide air pressure for maintaining intraocular pressure for retinal surgery.

The VCD HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumaticallydriven vitrectomy module.

The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries. The ProCare Plus™ Vitrectomy System is an AC powered device with an internal Li-Ion battery that provides backup power in the event that AC power is interrupted. The system is primarily run from one multifunction footswitch which gives the surgeon control over all of the surgical functions. The ProCare Plus Vitrectomy system provides many of the functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, illumination, and fluid-air exchange.

Here's a breakdown of the acceptance criteria and study information for the ProCare Plus Vitrectomy System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the ProCare Plus Vitrectomy System as being substantially equivalent to predicate devices. The acceptance criteria are primarily defined by meeting recognized standards and demonstrating equivalence in operational and technological characteristics. The "reported device performance" columns below generally reflect how the ProCare Plus compares or meets these established characteristics.

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

The document does not explicitly mention a "test set" in the context of clinical trials or AI/algorithm performance. The evaluation described is primarily a non-clinical comparative study against predicate devices and adherence to recognized standards. Therefore, information regarding sample size, data provenance, ground truth experts, and adjudication methods for a "test set" as typically understood in AI/imaging studies is not applicable to this submission.

The "test set" here refers to the actual physical device prototypes and components that underwent testing against the listed standards and in-house protocols. The provenance of this would be the manufacturing site of VisionCare Devices, Inc.

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

Not applicable, as this is a device substantial equivalence submission, not an AI/algorithm performance study requiring expert ground truth for image interpretation or similar. The "ground truth" for the device's performance is established by objective measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies or human-in-the-loop AI evaluations involving subjective assessments or disagreements among experts. The evaluation of this device is based on objective, standardized testing.

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 submission is for a medical device (vitrectomy system) and does not involve AI or human "readers" in the context of image interpretation or diagnosis. It's a hardware system for surgical procedures.

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

Not applicable. This is not an algorithm or AI product.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and performance benchmarks derived from predicate devices.
• Recognized international and national standards (e.g., IEC, ISO, EN) for medical device safety, electromagnetic compatibility, light hazard protection, sterilization, and packaging.
• Internal validation protocols (e.g., P1-112411 to FP1-113411) with their own predefined pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that utilizes a "training set."

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

Not applicable.

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