(240 days)
The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument.
The Storz device is intended to be used as an accessory to the Storz Microvit ® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manibulation of the instrument. The D7116 does not affect the functioning of the cutter.
The provided text describes a 510(k) premarket notification for a medical device accessory from 1996. This submission is for an accessory (a grip extension) for an existing vitrectomy cutter.
For a device like this, the "acceptance criteria" and "study" described in your prompt (which relate to performance metrics like sensitivity, specificity, or improvement with AI) are not applicable. This is because:
- The device is an accessory: Its primary purpose is to improve ergonomics or handling, not to perform a diagnostic or therapeutic function itself that would require clinical performance metrics.
- The device description explicitly states it "does not affect the functioning of the cutter." This is a key point for an accessory – it maintains the safety and effectiveness of the primary device it attaches to.
- The regulatory submission is a 510(k): This pathway demonstrates substantial equivalence to a legally marketed predicate device. The focus is on comparing features and intended use, not necessarily presenting new clinical performance data in the way a novel diagnostic or AI device would.
- The time period (1996): AI-driven medical devices and the associated performance criteria and study designs you've listed (MRMC, standalone algorithm performance, detailed ground truth establishment for AI training sets) were not part of medical device regulation or technology at that time.
Instead of performance criteria, the submission focuses on substantial equivalence to a predicate device. The "Device Comparison Chart" serves as the "study" proving this substantial equivalence, showing that the accessory does not introduce new questions of safety or effectiveness compared to the existing device it extends.
Here's how to address your questions given this context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Comparison for Equivalence) |
|---|---|
| Rear Aspect Annular Grip Present? | Met: Yes (for both predicate and D7116 extended probe) |
| Indication for Use Consistent? | Met: Vitrectomy, Surgeon's Preferred Technique (for both) |
| Alterations to Probe Required? | Met: No (for both) |
| Overall Goal: Does not affect cutter function and is substantially equivalent to a legally marketed predicate device. | Met: The chart demonstrates equivalence in the key characteristics assessed, and the description explicitly states "The D7116 does not affect the functioning of the cutter." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This type of data (test set size, provenance) is relevant for clinical performance studies, not for demonstrating substantial equivalence of a simple accessory that does not alter the primary device's function. The "sample" here refers to the device characteristics compared, not patient data.
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. No "ground truth" in the sense of clinical truth (e.g., disease presence) was established or required for this accessory. The "truth" in this context is whether the characteristics of the accessory (grip, indication, impact on probe) align with the predicate device. This would have been determined by engineering assessment and regulatory review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication was used.
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 is not relevant for an accessory from 1996, especially one that states it "does not affect the functioning of the cutter."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the clinical sense. The "ground truth" for this submission is the documented characteristics and intended use of the legally marketed predicate device (Storz MVS-3201 Vitrectomy Probe Pack), against which the new accessory (D7116 Vitrectomy Probe With Extension) was compared for substantial equivalence.
8. The sample size for the training set
- Not Applicable. No training set was used or required for this type of device submission.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.