(176 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 endoscopy and endoscopic surgery within the thoracic and abdominal cavities.
The HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs which is basically identical to the predicate devices, LTF-V, for the same application areas. The major difference from the predicate device is only the NBI function added to the subject device. The new endoscope is basically identical to the predicate device shown in above Table in intended use, and similar in specifications, performance without NBI observation.
This 510(k) submission describes the Olympus HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH, a device substantially equivalent to the predicate device OES Laparo-Thoraco Videoscope Type V (K955403). The primary difference is the addition of an NBI (Narrow Band Imaging) function.
This is a medical device submission and does not typically include clinical study data in the way an AI/ML software device would for performance metrics. The information provided focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria with clinical studies. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable or cannot be extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
No specific performance acceptance criteria or quantitative performance metrics are provided in the document. The submission focuses on demonstrating substantial equivalence in specifications and intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Identical to predicate device (endoscopy and endoscopic surgery within thoracic and abdominal cavities including female reproductive organs). |
| Technological Characteristics | Field of View: 90° (Predicate: 70°) |
| Direction of View: 0° (Identical) | |
| Optical System: Color (Identical) | |
| Angulation: UP: 100°, DOWN: 100°, RIGHT: 100°, LEFT: 100° (Predicate: 90° in all directions) | |
| Working Length: 370mm (Predicate: 330mm) | |
| Instrument Channel Inner Diameter: NA (Identical) | |
| NBI Function: Provided (Predicate: Not provided) | |
| Safety and Effectiveness | No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission focused on substantial equivalence based on device specifications and intended use, not a clinical study 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
Not applicable. Ground truth establishment with experts is not detailed for this type of submission.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is not an AI/ML device, and no MRMC studies are described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
Not applicable in the context of clinical "ground truth" for diagnostic performance. The "ground truth" here refers to the validated specifications and safety/effectiveness of the predicate device against which the subject device is compared.
8. The sample size for the training set
Not applicable. This is not an AI/ML device subject to training data.
9. How the ground truth for the training set was established
Not applicable.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.