(98 days)
The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.
LED Light Source (LLS-050 LED Illuminator)
The provided text is a 510(k) summary for the Sunoptic Technologies® LED Light Source (LLS-050 LED Illuminator). This document establishes the substantial equivalence of the LLS-050 to a legally marketed predicate device (Stryker L9000 LED Light Source, K082813).
The information requested pertains to the acceptance criteria and the study that proves a device meets those criteria. However, the provided 510(k) summary does not contain details of specific performance acceptance criteria or a study designed to directly prove the device meets these criteria in the context of clinical accuracy or diagnostic performance.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness." It also mentions that the device will conform to voluntary safety and performance standards (UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2), Medical EMC Stds. EN 60601-1-2).
Therefore, I cannot populate the requested table and sections with specific details about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test/training sets, expert qualifications, or ground truth methods, because such information is not present in the provided 510(k) summary. This type of detail is typically found in clinical study reports or validation documents, which are not part of this 510(k) summary.
Based on the provided document, here is what can be inferred or stated as "not applicable" given the nature of a substantial equivalence submission for an LED light source:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to Predicate Device (Stryker L9000 LED Light Source, K082813) | "The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness." |
| Conformance to Medical Safety Standards | Conforms to UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2) |
| Conformance to Medical EMC Standards | Conforms to EN 60601-1-2 |
| Device Functionality | Used to illuminate the site of surgery during minimally invasive surgical procedures (arthroscopy, laparoscopy, endoscopy). Light transmitted via fiber optic cable and scope. |
| (Specific quantitative performance metrics like light output, color temperature stability, etc., are not detailed in this summary.) | Not Detailed in provided summary |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable, as this is a substantial equivalence submission for a light source, not a diagnostic device requiring a clinical test set for performance metrics like sensitivity/specificity. The evaluation focuses on engineering and safety comparisons.
- Data Provenance: Not applicable for a clinical test set. The submission is based on engineering design, performance specifications, and safety standard adherence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth establishment for a diagnostic test is not relevant for an LED light source substantial equivalence submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, which is not the function of an LED light source.
- Effect size of human reader improvement: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device is a hardware component (light source), not an algorithm or AI system.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a diagnostic or algorithmic "ground truth." The "truth" in this context revolves around engineering specifications, safety standards compliance, and functional performance as an illuminator, which are evaluated against a predicate device.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
§ 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.