(83 days)
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.
The HD EndoEYE - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy The HD Lhoon is "Thigh Dominal cavities which is basically identical to the predicate device, OES Laparo- Thoraco Videoscope, for the same application areas.
The major difference from the predicate device is only the NBI function added to the subject device.
When the CLV-180 and CV-180 or the OTV-S7Pro and CLV-S40Pro are combined with HD EndoEYE, both an endoscopic image by white light illumination and that by NBI illumination can be observed within the thoracic and abdominal cavities. The CV-180 identifies when an NBI-compatible scope is connected, by using the Scope ID function provided with the scopes.
The provided text is a 510(k) summary for the Olympus HD EndoEYE, a high-definition digital video laparoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria in the way a clinical trial report would.
Here's an analysis based only on the provided text, as if it were a direct answer to your request. However, it's crucial to understand that this 510(k) summary does not contain the detailed study information you've requested regarding acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies (MRMC or standalone proficiency studies).
The document primarily relies on a comparison of specifications to demonstrate substantial equivalence, implying that if the new device's technical characteristics are similar or improved without introducing new safety/effectiveness concerns compared to legally marketed devices, it meets regulatory requirements.
Based on the provided K090980 510(k) Summary for the HD EndoEYE:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the form of performance thresholds for a study. Instead, it compares the technical specifications of the subject device (HD EndoEYE) to its predicate devices. The "reported device performance" is essentially presented as its specifications, which are deemed acceptable because they are similar or superior to the legally marketed predicate devices without significant changes affecting safety or effectiveness.
| Specification | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (HD EndoEYE) |
|---|---|---|
| Field of View | 70° (OES), 90° (LTF-VH) | 80° |
| Depth of Field | 18-100 mm (OES), 15-100mm (LTF-VH) | 20 to 120 mm |
| Direction of View | 0°, 30° (OES), 0° (LTF-VH) | 0°, 30°, 45° |
| Outer Diameter of Distal End | 11 mm (OES), 10mm (LTF-VH) | 10 mm |
| Optical System | Color | Color |
| Working Length | 320mm (OES), 370mm (LTF-VH) | 250-390mm |
| NBI Function | Not provided (OES), Provided (LTF-VH) | Provided |
Study Proving Acceptance Criteria:
The "study" presented here is a comparison of specifications between the subject device and its predicate devices. The conclusion states: "When compared to the predicate devices, the HD EndoEYE does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that by being substantially equivalent or demonstrating comparable technical performance to already-approved devices, it meets the inherent "acceptance criteria" for regulatory clearance.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a test set sample size or any clinical data provenance (e.g., country of origin, retrospective/prospective study) in the context of device performance testing.
- The review is based on a comparison of technical specifications and an assessment of substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention experts being used to establish ground truth for a test set in the context of a performance study.
- The "ground truth" for this 510(k) submission is the functional equivalence and safety assessment against legally marketed devices.
4. Adjudication Method for the Test Set:
- Not applicable. No test set performance study with adjudication is described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is mentioned. The document does not describe any human reader studies, either comparing human readers with AI assistance or in general. The device is a laparoscopic imaging system, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is an imaging instrument (hardware), not a standalone algorithm. Its performance is assessed through its physical and optical specifications, not an algorithmic output.
7. Type of Ground Truth Used:
- For this 510(k) submission, the "ground truth" is primarily technical specifications and functional characteristics of already legally marketed predicate devices, against which the new device is compared to establish substantial equivalence. No clinical outcome or pathology data is presented for this purpose.
8. Sample Size for the Training Set:
- Not applicable. This document is for a medical device (laparoscope), not an AI algorithm requiring a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set or AI algorithm is discussed.
Summary of what is not found in the document regarding your request:
The provided 510(k) summary is a regulatory filing for substantial equivalence, not a detailed clinical or performance study report in the traditional sense described by your questions. It focuses on comparing the new device's technical characteristics and intended use to existing predicate devices. Therefore, specific details about acceptance criteria derived from a performance study, sample sizes for test/training sets, expert qualifications, ground truth establishment (other than general device specifications), or clinical study methodologies (like MRMC or standalone performance evaluations) are not present in this document.
§ 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.