(86 days)
The Stryker 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 source through an optical cable and a scope.
The Stryker 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 source through an optical cable and a scope.
The provided text describes a 510(k) submission for the Stryker LED Light Source (L9000). A 510(k) submission establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested details such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not available in the provided document. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with specific metrics as one would find for a novel device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide specific performance acceptance criteria or quantitative performance results from a study. It states the device "will conform to the voluntary standards listed in section 5.1" (which is not provided) and that "The technological differences... do not raise new questions of safety or effectiveness." This implies equivalence in performance rather than meeting new, specific metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available: This type of information is related to a clinical performance study, which is not detailed in this 510(k) summary. The submission primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting a new, independent clinical assessment with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available: Ground truth establishment by experts is typically part of a clinical validation study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available: Adjudication methods are relevant for studies involving human interpretation and ground truth establishment, which are not detailed in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: No MRMC study is mentioned. This device is a light source, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The Stryker LED Light Source is a physical illuminator, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available: As no clinical study results are presented with a "test set," no ground truth type is mentioned. The primary "ground truth" for a 510(k) is the performance of the legally marketed predicate device.
8. The sample size for the training set
- Not Applicable/Not Available: "Training set" is a term relevant to machine learning or AI models, which this device is not. No equivalent concept applies to a light source in this context.
9. How the ground truth for the training set was established
- Not Applicable/Not Available: As above, this concept doesn't apply to this device.
Summary of available information:
The provided document describes a 510(k) submission for the Stryker LED Light Source (L9000). The key to its acceptance is demonstrating substantial equivalence to a predicate device, the Stryker Quantum 5000 Light Source (K961971).
- Intended Use: To illuminate the site of surgery during minimally invasive surgical procedures (arthroscopy, laparoscopy, endoscopy).
- Regulatory Basis: The device is deemed substantially equivalent to the predicate device, meaning "The technological differences between the LED Light Source (L9000) and the Stryker Quantum 5000 Light Source do not raise new questions of safety or effectiveness."
- Acceptance Criteria (Implied): Conformance to voluntary safety and performance standards (not explicitly listed in the provided text but mentioned as "section 5.1"). The primary "acceptance criterion" for a 510(k) is meeting the standard for substantial equivalence to a legally marketed predicate device.
- Study Proving Acceptance: The "study" is the submission itself, which compares the new device to the predicate device in terms of technology, intended use, and safety/effectiveness data available for the predicate. No new clinical performance study with specific device metrics is detailed. The FDA review determined that the information provided (including presumably technical comparisons and adherence to standards) was sufficient to demonstrate substantial equivalence.
§ 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.