(80 days)
These devices are indicated for use in arthroscopic procedures to provide visualization during endoscopic diagnosis and treatment of joints such as the knee, shoulder, hip, ankle, foot, elbow.
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).
This document is a 510(k) summary for the "ULTRA" Telescopes, an arthroscope manufactured by Olympus Winter & Ibe GmbH. The document outlines the device's identification, predicate device, description, indications for use, comparison of technological characteristics, and performance data.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the standards and types of performance tests conducted. The "reported device performance" is a general statement of compliance rather than specific quantitative results.
| Acceptance Criteria Category | Specific Acceptance Criteria (based on standards applied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO-10993 (Part 1, 5, 12) for biological safety, cytotoxicity, and chemical analysis. | "Biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 'Use of International Standard ISO-10993...'" and "The testing included the following tests: Biological Safety..., Cytotoxicity..., Chemical Analysis..." - Implied compliance. |
| Electrical Safety | Compliance with AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010. | "Electrical Safety was tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010..." - Implied compliance. |
| Electromagnetic Compatibility (EMC) | Not applicable, as the device is not electrically powered. | "Electromagnetic compatibility (EMC) is not applicable. The devices are not electrically powered and are just used with light from a light source." - Demonstrated non-applicability. |
| Thermal Safety | Compliance with IEC 60601-2-18:2009. | "Tested according to IEC 60601-2-18:2009..." - Implied compliance. |
| Optical Performance | Standards: ISO 8600-1:2013, ISO 8600-3:1997 + AM1(2003), ISO 8600-4:2014, ISO 8600-5:2005, ISO 8600-6:2005. Implicitly, the device should provide adequate visualization for arthroscopic procedures. | "Conducted tests cover optical... performance testing..." - Implied compliance with the standards listed. The Field of View (FOV) of subject devices is wider (Ø Factor 1.2), and maximum working length is minimally longer than the predicate. |
| Mechanical Performance | Implicitly, the device should withstand intended use, reprocessing, and shipping. Standards: ISO 8600-1 for general requirements. | "Conducted tests cover... mechanical performance testing, shipping tests, tests related to the expected service life..." - Implied compliance. |
| Illumination System | Implicitly, the device should adequately transmit light from an external source. | "Conducted tests cover... testing of the illumination system." - Implied compliance. |
| Design Validation/ Usability | Compliance with IEC 60601-1-6:2013. Implicitly, the device should be safe and effective for its intended use by users. | "Additionally, design validation/usability tests were conducted." - Implied compliance. |
| Risk Management | Compliance with ISO 14971:2007. Implicitly, risks must be acceptable. | "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007." - Implied compliance. |
| Reprocessing | Compliance with ISO 17665-1:2006 (Sterilization). Implicitly, the device must withstand and be effectively reprocessed as stated in the Instructions for Use. | "The 'ULTRA' Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use." (Supported by "ISO 17665-1:2006"). - Implied compliance. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the performance tests. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but these studies are typically conducted internally by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the type of device (arthroscope) and the nature of the tests conducted. The tests are primarily engineering and material performance assessments (biocompatibility, electrical, thermal, optical, mechanical) against established international standards, not diagnostic performance studies requiring expert interpretation of images or data.
4. Adjudication method for the test set
This section is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers, which is not the case for these safety and performance bench tests.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI or interpretation by multiple human readers, which is not the function of an arthroscope. The device ("ULTRA" Telescopes) is an imaging tool for direct visualization during surgery, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (algorithm only) was not done. This concept applies to AI algorithms, which are not part of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests in this submission are the specifications and limits defined by the referenced international standards. For example, the ground truth for biocompatibility is that the device should not elicit a toxic response as measured by ISO 10993 tests. For electrical safety, the ground truth is compliance with the safety limits defined in AAMI/ANSI ES 60601-1.
8. The sample size for the training set
This is not applicable. The "ULTRA" Telescopes are a mechanical optical device, not an AI-powered system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.