(97 days)
The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).
Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.
Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.
Scope: A rigid fiber optic scope designed for one-time use.
Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.
Procedural Kits: Supplementary items to assist in the surgical procedure.
The provided text states, "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted to prove the device meets acceptance criteria specific to its diagnostic or operational performance related to medical outcomes.
Instead, the device's substantial equivalence and performance are based on compliance with electrical safety and general medical equipment standards.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with Can/CSA C22.2 No 601.1-M90 | The InnerVue™ Diagnostic Scope System complies with this standard. |
| Compliance with CSA 601.1 Supplement 1:1994 | The InnerVue™ Diagnostic Scope System complies with this standard. |
| Compliance with CSA 601.1 Amendment 2:1998 | The InnerVue™ Diagnostic Scope System complies with this standard. |
| Compliance with CAN/CSA C22.2 No. 60601-2-18-01 | The InnerVue™ Diagnostic Scope System complies with this standard. |
| Compliance with UL Std No 60601-1 (1st Edition) | The InnerVue™ Diagnostic Scope System complies with this standard. |
| Compliance with IEC 60601-2-18 (1996) 2nd Edition | The InnerVue™ Diagnostic Scope System complies with this standard. |
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. No clinical testing with a test set was conducted for substantial equivalence. The performance assessment was based on compliance with electrical and safety standards, not clinical data or patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical testing was performed, so no experts were used to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical testing was performed.
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. No MRMC study was mentioned or conducted, as the device is not an AI-assisted diagnostic tool and no clinical testing was performed for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance was assessed as this is a medical device for visualization and illumination, not an AI or algorithm-based diagnostic tool. The performance was assessed against safety and electrical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth in a clinical sense was not established as no clinical testing was performed. The "ground truth" for compliance was the requirements outlined in the specified electrical and medical device safety standards.
8. The sample size for the training set
Not applicable. No training set was used as this device does not involve machine learning or AI that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.