(59 days)
Operative and Diagnostic Arthroscopy for visual imaging and light transmission to the operative area.
The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for an "Arthroscope" manufactured by Medifix, Inc. This letter confirms that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document is a regulatory approval letter based on substantial equivalence, not a study report detailing acceptance criteria and performance data for the device itself. It confirms that the device is similar enough to previously approved devices that it doesn't require a new, extensive clinical trial.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for the Arthroscope.
The prompt's questions are designed for a document describing a clinical study or a performance validation report, which this 510(k) clearance letter is not.
To answer your questions, if this were indeed a study report, the typical information would be as follows:
- Table of Acceptance Criteria and Reported Device Performance: This would typically be a table showing specific metrics (e.g., sensitivity, specificity, accuracy, precision for diagnostic devices, or specific physical performance measures for instruments) and the required threshold for acceptance versus the actual measured performance of the device in a study.
- Sample Size Used for the Test Set and Data Provenance: This would detail how many cases or patients were included in the evaluation set, the demographics, and where the data originated (e.g., retrospective analysis of a hospital database from the USA, prospective collection from a multi-center trial in Europe).
- Number of Experts Used to Establish the Ground Truth and Qualifications: This would specify how many human experts (e.g., 3 board-certified radiologists, 5 orthopedic surgeons) independently reviewed the test cases and their experience level.
- Adjudication Method: How disagreements among experts were resolved (e.g., a "2+1" rule where if two experts agree, that's the truth, and a third expert adjudicates if there's a split; or a "3+1" rule with a super-expert, or a simple majority vote).
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This would describe if human readers evaluated cases both with and without the AI assistance, and the statistical measure of improvement (e.g., AUC increase, sensitivity improvement).
- Standalone Performance: This refers to the algorithm's performance without any human intervention.
- Type of Ground Truth Used: The definitive truth used to evaluate the device. For example:
- Expert Consensus: The agreed-upon diagnosis or finding by a panel of experts.
- Pathology: Histopathological reports from biopsies or surgical resections.
- Outcomes Data: Long-term follow-up of patients to confirm a disease or condition.
- Radiological Follow-up: Subsequent imaging studies confirming findings.
- Sample Size for the Training Set: The number of cases or data points used to develop and train the device's algorithms or models.
- How the Ground Truth for the Training Set was Established: Similar to point 7, but specifically for the data used during the development phase.
Since the provided document is a 510(k) letter, none of this specific study-related information is available within the text.
§ 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.