(73 days)
The Syntec, Inc. True Light Endoilluminator with Pick is used to illuminate with visible spectrum light the intra ocular portion of the eye for improved visualization and manipulation during vitreo-retinal surgery.
The Endoilluminator with Pick is comprised of five basic components: the handpiece handle, the handpiece tube, the fiberoptic cable, the fiber optic cable sheath and the connector.
The provided text describes the Syntec, Inc. True Light Endoilluminator with Pick, a device cleared through the 510(k) pathway. This pathway relies on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than extensive clinical studies proving new safety and effectiveness. Therefore, the information requested about acceptance criteria, detailed performance metrics, sample sizes for testing and training, expert ground truth, adjudication methods, MRMC studies, and standalone performance studies is largely not applicable or not provided within this type of submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Intended Use: To illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to manipulate tissue, during vitreoretinal surgery. | The Syntec, Inc. True Light Endoilluminator with Pick is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to manipulate tissue during vitreoretinal surgery. (Matches intended use) |
| Material Biocompatibility: Compatible with body tissue and fluids. | Made of same materials as predicate device, meeting US Pharmacopoeia Class VI criteria. |
| Sterilization Method: Effective sterilization. | Sterilized using ethylene oxide gas, validated by the overkill method. |
| Light Output Intensity: Similar to predicate. | Same as predicate device. |
| Spot Size: Similar to predicate. | Same as predicate device. |
| Overall Design (Functional): Similar to predicate. | "Similar design." Only device differences are noted as cosmetic. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. The 510(k) submission for this device does not involve a "test set" in the sense of a clinical performance study with human subjects or a defined dataset. Substantial equivalence is demonstrated through comparison of technical characteristics and intended use to a legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided. Ground truth, in this context, refers to a consensus or gold standard used to evaluate a diagnostic or AI device's performance. Since this is a surgical illumination/manipulation tool cleared via substantial equivalence, such a "ground truth" and expert panel for a test set is not part of the submission described.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. An MRMC study is typically performed for diagnostic devices to assess the impact of AI assistance on human reader performance. This device is an illumination and manipulation tool, not a diagnostic AI system, and no such study is mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- No. This device is a physical surgical tool and does not employ an algorithm that would have a "standalone" performance.
7. The Type of Ground Truth Used:
-
Not applicable / Not provided in the traditional sense. The "ground truth" for this 510(k) submission relies on the established safety and effectiveness of the predicate devices:
- Grieshaber Disposable Standard Micro Lite Pipe with Pic (K875004)
- Gamp & Associates Disposable Fiberoptic Endoilluminator with Pick
The Syntec device demonstrates substantial equivalence by showing that its materials, design (functionally), intended use, and key performance characteristics (like light output) are the same or very similar to these legally marketed predicates.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. As this is not an AI/ML device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. (See point 8).
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.