(66 days)
Trephine made for single use and for the extraction of the cornea.
A single use ophthalmic device designed to extract the cornea.
The Gayheart™ Corncal Excision Device (K022843) is an ophthalmic trephine, a single-use device designed for corneal extraction. Its acceptance criteria and performance were assessed through non-clinical tests demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | Measurements of the Gayheart™ Corneal Excision Device (trephines) were substantially equivalent to the measurements of the predicate devices (Katena, Storz, Rhein, Stephens Ophthalmic Trephines). |
| Sharpness | Sharpness tests (number of cuts and initial cutting sharpness) showed that Stephens trephines perform as well as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set. The tests involved "measurements of the trephines" and "sharpness tests" on the Gayheart™ Corneal Excision Device and a comparison to predicate devices, implying a sufficient number of devices were tested to draw a comparison. The data provenance is not explicitly stated but is implicitly from an internal test by Stephens Instruments as part of their 510(k) submission. This is considered retrospective data from the manufacturer's testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No direct mention of experts or their qualifications for establishing ground truth is provided. The performance tests (dimensional equivalency and sharpness) appear to be objective measurements, likely conducted in a lab setting by technical personnel rather than clinical experts.
4. Adjudication Method for the Test Set
No adjudication method is described. The tests were objective measurements (dimensions, sharpness), not subjective interpretations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is a Class I ophthalmic trephine, and the submission does not mention any clinical studies or human reader involvement in its evaluation for this 510(k).
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Gayheart™ Corneal Excision Device is a physical surgical instrument, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims was based on:
- Objective Measurements: Directly measured dimensions, number of cuts, and initial cutting sharpness of the devices.
- Comparison to Predicate Devices: The performance was assessed against established predicate devices, implying that the performance of these legally marketed devices served as the benchmark or "ground truth" for acceptable performance for this type of device.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical surgical instrument and does not involve any artificial intelligence or machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.