(294 days)
To provide single-use components to be used in conjunction with a facility's existing compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used in accordance with the equipment manufacturer's instructions, performed by a certified clinician in a clinical setting, as follows:
- (1) Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
- (2) Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures;
- (3) Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures:
- (4) Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures;
- (5) Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
- (6) Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.
Ophthalmic surgical kits/packs containing components used for irrigation/aspiration, anterior and posterior vitrectomies, phacoemulsification, and or administration of fluids.
The provided document describes a 510(k) premarket notification for ophthalmic surgical kits/packs, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or human-in-the-loop performance) is not applicable or cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.
Here's what can be extracted, adapting to the context of a traditional medical device submission for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense for this submission. The "acceptance criteria" here is implicitly demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the device's technological characteristics and intended use being similar to existing (predicate) devices.
| Acceptance Criteria Category | Description (as inferred from the document) | Reported Device Performance / Assessment |
|---|---|---|
| Technological Characteristics | No substantive changes in materials, basic components, or manufacturing/sterilization methods compared to predicates. | "There are no substantive changes in materials, basic components (the majority of which have their own 510(k)'s, or method of manufacture or sterilization between these devices and their predicates." |
| Biocompatibility | Components must be biocompatible (cytotoxicity, hemolysis). | "The packs' components have been tested by an independent lab for biocompatability (cyctotoxicity, hemolysis) with no problems noted." |
| Function and Use | Intended function and use must be similar to predicate and pre-amendment devices. | "The function and use of these packs and their components are no different than that of the predicates, as well as other similar devices, packs as well as individual components, marketed since pre-amendment." |
| Safety and Effectiveness | Device is as safe and effective as substantially equivalent predicate devices. | The FDA's letter of "substantial equivalence" determination implies this criterion was met. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of evaluating an AI/ML algorithm's performance on cases. The "testing" mentioned is for biocompatibility of components.
- Sample size for biocompatibility testing: Not specified, but stated to be done by an independent lab.
- Data provenance: Not applicable for performance evaluation of an AI/ML device. Biocompatibility testing results come from laboratory tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
Not applicable. This submission doesn't involve establishing "ground truth" through expert review of medical images or data for an AI algorithm.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" or diagnostic performance evaluation described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a traditional medical device submission for ophthalmic surgical kits/packs, not an AI/ML device. MRMC studies are used to evaluate human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
No. This is a traditional medical device.
7. The Type of Ground Truth Used
Not applicable. There's no diagnostic or prognostic output from these surgical kits that would require "ground truth" for performance evaluation in the AI/ML context. The closest concept might be conformance to manufacturing specifications or sterility, but that's not what "ground truth" typically refers to in AI/ML performance evaluation.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML algorithm or training set.
§ 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.