(126 days)
The D.O.R.C. Harmony Total Vitrectomy System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment (vitrectomy).
The D.O.R.C. Harmony Total Vitrectomy System is an integrated system for posterior segment eye surgery. It provides the majority of functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, phacofragmentation, illumination, diathermy, air system and viscous fluid injection/extraction. The system is operated from one multifunction footswitch which gives the surgeon control over all of the surgical functions. The D.O.R.C. Harmony Total Vitrectomy System which includes the system, multifunction footswitch, trolley, automatic infusion pole and various sterile and non-sterile accessories provides the majority of functions needed to complete a posterior segment vitrectomy. The system is ac powered and also requires a source of medical grade compressed air to provide for some of the system functions.
The provided text is a 510(k) premarket notification for the D.O.R.C. Harmony Total Vitrectomy System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic or AI-powered medical device.
Therefore, many of the requested elements (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission.
The "study" in this context is the comparison of technological characteristics of the D.O.R.C. Harmony Total Vitrectomy System to its predicate devices. The acceptance criteria are implicit in the FDA's "substantial equivalence" determination, meaning the new device must be as safe and effective as a legally marketed predicate device.
Here's an breakdown based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, there isn't a formally stated "acceptance criteria" in terms of specific performance metrics with PASS/FAIL thresholds for a novel diagnostic. Instead, the acceptance criteria are satisfied by demonstrating that the new device's technological characteristics are substantially equivalent to legally marketed predicate devices. The "reported device performance" is essentially the listed specifications of the D.O.R.C. Harmony Total Vitrectomy System, as compared to the predicate devices.
| Feature/Specification | Acceptance Criteria (Implicit: Comparable to Predicate) | D.O.R.C. Harmony Total Performance | Predicate Devices (Range/Example) |
|---|---|---|---|
| Intended Use | Posterior segment ophthalmic surgery | Posterior segment ophthalmic surgery | Same |
| Vitrectomy Type | Guillotine cutter (or equivalent) | Guillotine cutter | Guillotine or radial reciprocating |
| Vitrectomy Drive Mechanism | Pneumatic or electric | Pneumatic or electric | Pneumatic |
| Maximum Cut Rate | Comparable to predicate devices | 800 cuts/minute | 750 - 2500 cuts/minute (predicates show a range) |
| Aspiration Type | Venturi (or equivalent) | Venturi | Venturi |
| Linear Control | Present | YES | YES |
| Maximum Vacuum | Comparable to predicate devices | 500 mm Hg | 500 - 600 mm Hg |
| Phacofragmentation | Present (if predicate has it) | YES | YES |
| Phaco Frequency | Comparable to predicate devices | 40 kHz | 28.5 kHz - 40 kHz |
| Diathermy | Present (if predicate has it) | YES | YES |
| Diathermy Frequency | Comparable to predicate devices | 13.56 MHz | 600 kHz (one predicate) |
| Diathermy Max Power | Comparable to predicate devices | 12 watts | 7.5 - 10 watts |
| Fiber Optic Light Source | Present (if predicate has it) | YES | YES |
| Light Output | Dual/Single | Dual | Dual |
| Lamp Type | Halogen (or equivalent) | Halogen | Unknown for predicates |
| Lamp Wattage | Comparable to predicate devices | 150 watts | Unknown for predicates |
| Air Infusion | Present (if predicate has it) | YES | YES |
| Air Infusion Max Pressure | Comparable to predicate devices | 95 mm Hg | 99 - 120 mm Hg |
| Viscous Fluid Injection | Present (if predicate has it) | YES | NO (for Storz, MID Labs, Scieran) |
| Viscous Fluid Injection Viscosities | 1000 or 5000 cs | 1000 or 5000 cs | 1000 or 5000 cs (Alcon) |
| Viscous Fluid Extraction | Present (if predicate has it) | YES | NO (for Storz, MID Labs, Scieran) |
| Multifunction Footswitch | Present | YES | YES |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a comparison of device specifications to predicate devices, not a study involving patient data or a "test set" in the context of diagnostic accuracy. The provenance of the data is the device's own specifications and publicly available information about predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No "ground truth" derived from expert assessment of a test set is mentioned or required for this type of submission. The "ground truth" is the demonstrated functionality and specifications of the device itself and its predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication process is described for a test set.
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 is not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a surgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is the functional specifications and intended use of the D.O.R.C. Harmony Total Vitrectomy System and its predicate devices. Substantial equivalence is established by demonstrating that these characteristics are similar enough to ensure equivalent safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is a hardware surgical system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.