(73 days)
The system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and large joint arthroscopic procedures.
The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the VS3-ETV device:
The provided text is a 510(k) summary for the VS3-ETV, which is a modified version of the predicate device, the VS3 Stereoscopic High Definition Vision System (K141002). This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for clinical outcomes.
Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this type of document because the submission strategy is based on comparing technological characteristics and non-clinical performance to a cleared predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially derived from the technological characteristics of the predicate device and the established recognized standards the device conforms to. The "reported device performance" are the stated characteristics of the proposed device, which are shown to be equivalent to the predicate.
| Feature/Parameter | Acceptance Criteria (from Predicate VS3, K141002) | Reported Device Performance (Proposed VS3-ETV) |
|---|---|---|
| Able to function with no camera | No | No |
| Working distance range | 8mm - 70mm | 8mm - 70mm |
| Field Of View | 70° - 95° | 70° - 95° |
| Direction of view | 0º - 70º | 0º - 70º |
| Horizontal resolution | >199 lpf | >199 lpf |
| Vertical resolution | >199 lpf | >199 lpf |
| Identification | Support functionality to permit the system to identify scope | Support functionality to permit the system to identify scope |
| Irrigation Sheath | Support an optional irrigation sheath with a standard Storz-style connector | Support an optional irrigation sheath with a standard Storz-style connector |
| Endoscope diameter | 4 - 5.5 mm | 4 - 5.5 mm |
| Endoscope length | 175 - 300 mm (±5 mm) | 175 - 300 mm (±5 mm) |
| Depth of field | 7 - 30mm and 15 - 60mm | 7 - 30mm and 15 - 60mm |
| Working Channels | No | Yes (Addition of 3 working channels is the key change) |
| Additional Standards Conformance: | IEC 60601-1-2 (EMC) | |
| IEC 60601-1 (Basic Safety) | ||
| IEC 60601-1-4 (Programmable Medical Systems) | Conforms to these standards (implied by statement "The subject device conforms to the following recognized standards") | |
| Reuse Validation | Demonstrated safe reuse of predicate device | Performed to demonstrate no changes compared to predicate |
| Cleaning & Disinfection Validation | Demonstrated effective predicate disinfection | Performed to demonstrate no changes compared to predicate |
| Autoclave & Sterilization Validation | Demonstrated effective predicate sterilization | Performed to demonstrate no changes compared to predicate |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission showing substantial equivalence, the "acceptance criteria" are not typically clinical performance metrics with target values (e.g., sensitivity, specificity). Instead, they are the demonstration that the modified device's technological characteristics and non-clinical performance (e.g., safety, sterilization) are either identical or equivalent to the predicate device, or that any differences do not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "performance testing" mentioned refers to non-clinical tests like reuse validation, cleaning, disinfection, and sterilization. The sample size for these non-clinical tests (e.g., number of instruments tested for sterilization cycles) is not provided.
- Data Provenance: Not applicable as it's not a clinical study on patient data. The non-clinical tests were likely conducted by the manufacturer, Visionsense Ltd., in Israel or a contract testing lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts/Qualifications: Not applicable. There is no mention of a human-read clinical test set or ground truth established by experts in this 510(k) summary. The performance data presented are physical/technical specifications and results from non-clinical validation tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
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
- MRMC Study / Effect Size: Not applicable. This device is an endoscope/vision system, not an AI diagnostic algorithm for image interpretation. There is no mention of AI assistance for human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a hardware device (endoscope system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: Not applicable in the traditional sense of a diagnostic device. For the technical performance characteristics, the "ground truth" would be established by direct measurement with calibrated instruments (e.g., optical resolution charts for horizontal/vertical resolution, rulers for working distance). For the non-clinical tests like sterilization, the ground truth is established by validated laboratory methods (e.g., biological indicators for sterility assurance).
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. (See #8)
Summary of Device and Study Focus:
The VS3-ETV is an endoscope system. The 510(k) submission focuses on demonstrating that the modified device (VS3-ETV, with added working channels) is substantially equivalent to a previously cleared predicate device (VS3, K141002). This means the primary "study" involved comparing the technical specifications and conducting non-clinical performance tests (reuse, cleaning, disinfection, sterilization) to show that the addition of working channels does not introduce new safety or effectiveness concerns compared to the predicate. The reference device K983365 (Aesculap Minop System) was used to establish precedence for the irrigation and working channels concept itself. There is no mention of clinical trials or studies involving patient data to establish new clinical performance criteria for this modification.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.