(15 days)
The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures.
The LO-50 Light Source is a fiber optic light source using a single solid state light emitting element to produce visible light required to illuminate surgical sites for indirect visualization during medical procedures. The LED produces white light by electroluminescence (as in a tungsten filament lamp) or fluorescence (as in a xenon lamp.) Both of the latter technologies use large amounts of electricity and generate significant heat in creating light. LED generates a greater light output as a percentage of energy input to the lamp. It uses Pulse Width Modulation to control the on/off time of the LED at full output to determine brightness. The LO-50 light source uses a small optical element to capture and direct the light to a port into which one of many common medical light guides may be fitted to conduct the light where needed. The unit consists of the aforementioned LED, cooling fan, light port, sheet metal covers, plastic front and rear covers, and front mounted power switch and dimming control. The unit is very similar in design, format, functionality and size to other light sources including the predicate device.
Here's a breakdown of the acceptance criteria and the study information for the LO-50 LED Light Source, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (LO-50 LED Light Source) |
|---|---|---|
| Safety Standards | UL60601-1 compliance | Conforms |
| CAN/CSA 22.2 No. 601.1 compliance | Conforms | |
| EN60601-1-2 (EMC Standard) compliance | Conforms | |
| Operational Equivalence | User interface and controls | Essentially equivalent to predicate device |
| Ease of connection of common light guides | Essentially equivalent to predicate device | |
| Light Quality | Brightness of emitted light (with reference light guide) | Essentially equivalent to predicate device (equivalent brightness) |
| Brightness and quality of illumination (with typical fiber optic headlight system and arthroscope) | Essentially equivalent to predicate device (equivalent brightness and quality of light) | |
| Safety During Use | Operating temperatures of light sources, accessible parts, and lighted instruments | Essentially equivalent to predicate device |
| Technological Equivalence | LED technology | Nearly identical to predicate device |
| Power supply | Nearly identical to predicate device | |
| User interface | Nearly identical to predicate device | |
| Connectivity | Nearly identical to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "non-clinically tested" and comparisons using "a reference light guide," "a typical fiber optic headlight system," and "arthroscope," implying a limited number of units or setups were used for testing.
- Data Provenance: The testing was conducted by the manufacturer, Fiberoptics Technology, Inc., likely at their facility in Pomfret, CT, USA. The data is retrospective in the sense that it's reported after the testing was completed for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided. The study was a non-clinical comparison focusing on objective performance metrics and safety standards rather than a clinical study requiring expert assessment of outcomes or interpretations.
4. Adjudication Method for the Test Set
- Not applicable. The study involved objective measurements and comparisons against a predicate device and established technical standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The document describes a non-clinical comparison to a predicate device, focusing on technical and safety equivalence, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in spirit. While not an "algorithm" in the typical sense of AI, the performance of the device itself (LO-50 LED Light Source) was evaluated standalone against the predicate device and established standards. There was no human-in-the-loop performance component or AI involved.
7. Type of Ground Truth Used
- The "ground truth" for this device's evaluation was primarily based on:
- Predicate device performance: The Sunoptics Technologies LLS-050 LED Light Source (K093792) served as the benchmark for "equivalent brightness and quality of light," "similar control and operation," and "interfaced correctly and effectively."
- Industry Safety and Performance Standards: UL60601-1, CAN/CSA 22.2 No. 601.1, and EN60601-1-2 provided objective thresholds for safety and electromagnetic compatibility.
- Objective Measurement: Direct measurements of brightness, temperature, and verification of user interface and connectivity.
8. Sample Size for the Training Set
- Not applicable. This device is a hardware light source, not a software algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML device requiring a training set.
§ 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.