(78 days)
Stryker Arthroscopes are endoscopic devices into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).
Stryker Arthroscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during arthroscopic procedures. The devices are available in a variety of outer diameters and working lengths.
The arthroscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process the device for initial use, as well as to reprocess the device after each use. The devices are available in an evepiece and a C-Mount design. The evepiece arthroscopes connect to the camera system through a separate coupler; the C-Mount arthroscopes connect directly to the camera system through an integrated coupler.
Stryker's arthroscopes achieve their intended use by guiding light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display by a separate camera system. The arthroscopes' optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.
The provided document is a 510(k) Summary for the Stryker Arthroscopes. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies on AI algorithms or advanced performance metrics. As such, the document does not contain the information required to answer many of the questions asked, particularly those related to acceptance criteria, AI performance, ground truth, and sample sizes for AI studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a table of tests performed and their results, but it does not explicitly state the acceptance criteria for each test. It only indicates "PASS" for all tests.
| Test | Method | Reported Device Performance | Acceptance Criteria (Not provided) |
|---|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 60601-2-18 | PASS | Not explicitly stated |
| Packaging | ASTM D4169 | PASS | Not explicitly stated |
| Visual Inspection | ISO 8600-1 | PASS | Not explicitly stated |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 | PASS | Not explicitly stated |
| Cleaning and Disinfection | AAMI TIR 12, AAMI TIR 30, ISO 15883-5, ISO 15883-2 | PASS | Not explicitly stated |
| Sterilization | AAMI ST79, AAMI ST58, ISO 17665-1, ISO 14937 | PASS | Not explicitly stated |
| Performance - Bench (Needle Torque) | - | PASS | Not explicitly stated |
| Performance - Bench (Needle Torque - Dynamic Torque) | - | PASS | Not explicitly stated |
| Performance - Bench (Focus Ring Torque) | - | PASS | Not explicitly stated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes tests primarily related to the physical and functional aspects of the arthroscope (electrical safety, packaging, biocompatibility, cleaning, sterilization, mechanical performance), not data-driven performance studies typically associated with AI/software devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The device is an arthroscope, a physical optical instrument. The tests mentioned are for its physical and functional characteristics, not for diagnostic accuracy that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As explained above, the tests are primarily for physical and functional performance, not diagnostic accuracy requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The device is a traditional arthroscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of an algorithm or standalone performance in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The performance tests are for physical device characteristics, where "ground truth" would be defined by engineering specifications and standards, not clinical diagnostic outcomes.
8. The sample size for the training set
There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
There is no mention of a training set or its ground truth, as this is not an AI/machine learning device.
Summary based on available information:
The provided document is a 510(k) summary for a traditional medical device (Stryker Arthroscopes) and demonstrates substantial equivalence to a predicate device based on design, intended use, operating principles, technological characteristics, and safety features. The performance testing focuses on standard engineering, safety, and reprocessing validations rather than AI-specific performance criteria or clinical diagnostic accuracy studies. Therefore, most of the questions related to acceptance criteria for AI performance, ground truth, and sample sizes for AI studies cannot be answered from this document.
§ 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.