(81 days)
The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrlst (carpal tunnel syndrome), temporal-mandibular joint, ankle and elbow.
The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user.
The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.
The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
The provided document is a 510(k) summary for a medical device (asap arthroscope). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this type of regulatory submission for a simple arthroscope does not typically contain detailed studies with acceptance criteria, reported performance metrics, or information related to AI/algorithm performance, multi-reader multi-case studies, or specific ground truth establishment methods as you've requested.
The document's purpose is to demonstrate that the new arthroscope is "substantially equivalent" to already legally marketed devices, primarily by showing similar design, materials, indications for use, and compliance with relevant standards. It focuses on safety and effectiveness through equivalence, rather than new performance claims that would necessitate rigorous quantitative studies of diagnostic accuracy.
Therefore, most of the information you've requested cannot be extracted from this document based on the nature of the device (a reusable arthroscope, not an AI-powered diagnostic tool).
Here's an attempt to answer what can be inferred or directly stated, and where the information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the acceptance criteria are met if the asap arthroscope is "substantially equivalent" to the predicate device (AMO Arthroscope K962330) in terms of specifications, intended use, materials, and compliance with voluntary standards.
- Reported Device Performance: The document states that the "specifications and intended use of the asap arthroscope are the same to those of the claimed predicate devices. There are no significant differences between the asap arthroscope and the claimed predicates in design or conditions of intended use." It also mentions successful validation of the ability to repeatedly sterilize the device.
| Acceptance Criteria Category | Specific Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (asap Arthroscope) |
|---|---|---|
| Design | No significant differences from predicate device | "No significant differences" |
| Materials | Same specifications as predicate device to ensure biocompatibility; conforms to applicable ISO standards | "Constructed of materials of the same specifications" to ensure biocompatibility; "conforms to applicable ISO standards" |
| Intended Use | Same as predicate device | "Same to those of the claimed predicate devices" |
| Specifications (General) | Same as predicate device | "Same to those of the claimed predicate devices" |
| Sterilization | Ability to be repeatedly and adequately sterilized validated | "Ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." |
| Safety | Compliance with voluntary standards (IEC 60601-2-18, DIN 58105, DIN 17442, DIN 980) | "Complies with applicable portions of voluntary standards IEC 60601-2-18, DIN 58105, part 1 and 2, DIN 17442 (medical steel), as well as applicable portions of DIN 980" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided: This type of information (sample size, data provenance for specific tests) is not typically detailed in a 510(k) for a basic arthroscope. The review is based on bench testing, material equivalence, and standard compliance, not clinical diagnostic performance studies on patient data.
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)
- Information Not Provided: Ground truth as described (e.g., for diagnostic accuracy) is not relevant or applicable to this device and its 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Provided: Adjudication methods are not relevant for the type of evaluation performed for this device.
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
- Information Not Provided & Not Applicable: This is a rigid arthroscope, not an AI-powered diagnostic device. MRMC studies or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Provided & Not Applicable: This is a rigid arthroscope, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information Not Provided & Not Applicable (in the requested context): The "ground truth" for this device relates to engineering specifications, material properties, and functionality, verified through bench testing and compliance with standards, rather than clinical diagnostic outcomes or expert consensus on medical images/data.
8. The sample size for the training set
- Information Not Provided & Not Applicable: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Information Not Provided & Not Applicable: As above, no training set. The "ground truth" for the device's properties is established by engineering principles, material science, and regulatory standards.
§ 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.