(80 days)
Elliquence endoscopes are indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.
The Endiscope is an optical and fiber optic based rigid endoscope available with working channels of 2.8 mm, 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy.
The Endiscope Cervical is an optical and fiber optic-based rigid endoscope available with a working channel of 2.2 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine.
Elliquence endoscopes may be attached to standard fiber optic light sources, commonly available video adapters and cameras such as Storz, Olympus and Wolf.
The devices are reusable, delivered in non-sterile conditions and available in various designs:
- Outer Diameters from 3.6 mm to 7.0 mm
- Diameter of working channel from 2.2 mm to 4.3 mm
- Working length from 95 mm to 208 mm
- Direction of view: 0%6° (Endiscope Cervical), 30° (Endiscope)
- Viewing angle 80° +/- 5°
The provided document is a 510(k) summary for the Elliquence Endiscope and Endiscope Cervical devices. It describes the device, its intended use, comparison to a predicate device, and non-clinical testing performed. However, it explicitly states, "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
Therefore, I cannot provide information about acceptance criteria or a study proving the device meets them in the context of clinical performance in human subjects from this document. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than performing a new clinical efficacy study with specific performance metrics.
I can, however, extract details about the non-clinical testing that was performed to demonstrate aspects of safety and effectiveness, which could be considered 'acceptance criteria' in a non-clinical sense.
Here's an analysis based on the document's content regarding non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Thermal Safety: According to IEC 60601-2-18, the device should not pose thermal hazards. | "Results show, that thermal hazards may be excluded if the devices are used according their indications." |
| Electrical Safety: According to IEC 60601-2-18, the device must meet electrical safety requirements. | "Results indicate electrical safety of the devices as required per respective standard." |
| Optical Performance: Continuous checks during final inspection for optical performance before release. | "Every device is checked for optical performance before final release." |
| Sterilization: Validation of specified sterilization cycle according to ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665, and EN ISO 17664. | "Safety and efficiency of the specified sterilization cycle referenced within the instructions for use has been validated under consideration of the requirements set out in ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665 and EN ISO 17664." |
| Biocompatibility: Acceptable levels of biocompatibility according to ISO 10993-1. | "Testing has been conducted with greatest challenge devices and provides evidence on acceptable levels of biocompatibility." |
2. Sample Size Used for the Test Set and Data Provenance
For non-clinical testing, the concept of a "test set" in the context of device performance in humans or AI algorithms does not directly apply here. These tests are laboratory-based and involve physical devices or materials.
- Sample size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many devices were tested for thermal safety). It generally refers to "the devices" or "greatest challenge devices."
- Data provenance: Not applicable in the sense of human subject data origin. These are laboratory test results.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth in this context typically refers to clinical diagnoses or outcomes. For non-clinical, laboratory-based testing, 'ground truth' is established by the specifications of the standards (e.g., IEC 60601-2-18, ISO 10993-1) themselves, and the expertise lies in the certified laboratories and personnel performing the tests according to those standards.
4. Adjudication Method
Not applicable for non-clinical, laboratory-based testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission explicitly states it did not rely on clinical performance data.
6. Standalone Algorithm Performance Study
Not applicable. This device is an endoscope, not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical tests: The "ground truth" is adherence to established international and national consensus standards (e.g., IEC 60601-2-18, ISO 10993-1, ANSI/AAMI ST81, ANSI/AAMI TIR12, EN ISO 17665, EN ISO 17664).
8. Sample Size for the Training Set
Not applicable. This device is an endoscope, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.