(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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with their arms raised, or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Mr. George Albulescu President Medifix. Inc. 8727 Narragansett Morton Grove, Illinois 60053
Re: K992474 Trade Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 23, 1999 Received: July 26, 1999
Dear Mr. Albulescu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. George Albulescu
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known): Device Name: Arthroscope / MEDIFIX Inc. Page 1 of 1
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992474 |
| Prescription Use (Per 21 CFR 801.1091 | ✓ |
| OR | |
| Over-The-Counter Use ______ | |
| (Optional Format 1-2-96) |
§ 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.