(132 days)
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.
| Acceptance Criteria (Characteristic) | Predicate Device Performance (Benchmark) | ProCare Plus Vitrectomy System Performance (Reported and Proven) |
|---|---|---|
| Intended Use | Anterior/Posterior Ophthalmic Surgery | Anterior/Posterior Ophthalmic Surgery |
| Vitrectomy: | ||
| Type | Guillotine | Guillotine |
| Drive Mechanism | Pneumatic | Pneumatic |
| Maximum Cut Rate | 2000 cuts/minute (Vitman), 1200 cuts/min (YPR 2001, Intrector) | 3000 cuts/minute (Exceeds predicate devices) |
| Irrigation/Aspiration: | ||
| Aspiration Type | Venturi (Vitman, YPR 2001), Syringe (Intrector) | Electrical (On-board vacuum pump) - claimed substantially equivalent |
| Linear Control | Yes | Yes |
| Maximum Vacuum | 400 mmHg (Vitman, YPR 2001) | 400 mmHg |
| Fiber Optic Light Source: | ||
| Dual/Single Output | Dual (Vitman), Single (YPR 2001) | Single |
| Lamp Type | Halogen | HB LED - claimed substantially equivalent, reduces heat & blue light toxicity |
| Air Infusion: | ||
| Maximum Pressure | 95 mmHg | 95 mmHg |
| Multifunction Footswitch | Yes | Yes |
| Power: | ||
| AC Power | Yes | Yes |
| Battery | Yes (Vitman, Intrector), No (YPR 2001) | Yes (Li-Ion, 8 hours backup) - claimed substantially equivalent, more capacity |
| Safety Standards | Compliance with relevant IEC, ISO, EN standards | Passed all safety tests for demonstrated compliance with: IEC 60601-1, IEC 60601-1-2, EN ISO 15004-2, ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 11607-1, IEC 62471 |
| In-House Performance Testing | N/A (Internal benchmarks) | Passed internal tests: Main AC Electrical System, Internal DC Electrical System, Pneumatic Cutting System, Pneumatic Air Exchange System, Vacuum System, Lightsource, Battery Performance Testing, Pneumatic Handpiece Testing, Ergonomics/Portable System Testing, Medical Air Gas Cylinders & Regulators, Foot Control, Pneumatic Handpiece HSP Burst Testing |
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.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.