(245 days)
The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).
Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.
This 510(k) summary describes a medical device, the Ultimate Vit Enhancer (UVE), which is a vitrectomy device. The submission focuses on substantial equivalence to a predicate device and outlines performance testing rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML-driven devices.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. Instead, it broadly states that "functional requirements and specifications have been met." The performance data described are related to the mechanical and physical attributes of the device.
| Performance Aspect | Reported Device Performance |
|---|---|
| Heat generation | "Testing was conducted to measure heat generation in the vitreous cutter operated at a range of cut rates." |
| "Requirements as outlined in the testing were met." | |
| Cutter integrity | "Cutter integrity, including evaluation of the potential for metal flaking, was tested during extended exercising of the vitreous cutter at a range of cut rates." |
| "Requirements as outlined in the testing were met." | |
| Fluid dynamics | "Fluid dynamics were evaluated by measuring displacement of a marker in vitreous at a range of cut rates." |
| "Requirements as outlined in the testing were met." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of patient data or clinical samples. The testing described appears to be laboratory-based bench testing on the device itself and potentially on simulated vitreous material (for fluid dynamics). No patient data is mentioned, thus no country of origin or retrospective/prospective nature can be determined.
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)
Not applicable. The testing described is for a mechanical device's physical performance, not for interpreting medical images or making diagnoses that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication is mentioned or implied for the type of bench testing performed.
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. This device is a mechanical vitrectomy instrument, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a standalone hardware console used in conjunction with a standard vitrectomy machine and a specific vitreous cutter. It is not an algorithm, and its performance is not evaluated in terms of "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned (heat generation, cutter integrity, fluid dynamics), the "ground truth" would be the direct measurements obtained from the physical testing itself against pre-defined engineering specifications and requirements. This is not medical ground truth established by experts or pathology.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system and does not involve a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML system and does not involve a training set or its associated ground truth establishment.
§ 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.