(87 days)
Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or laceration) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant
Not Found
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided FDA 510(k) letter (K991238) for the "FCI Crawford Probe Intubation Sets," it is not possible to extract information about acceptance criteria or a study proving device performance in the way typically expected for an AI/software device.
This document is a substantially equivalent (SE) letter for a physical medical device (FCI Crawford Probe Intubation Sets), not a software or AI device. The FDA's 510(k) pathway for physical devices primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria as would be expected for a novel AI/software product.
Therefore, most of the requested information (like sensitivity, specificity, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present and not applicable to this type of regulatory submission.
However, I can extract the following limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not specify quantitative acceptance criteria for performance. The "acceptance" here is the FDA's determination of "substantial equivalence" to a predicate device.
- Reported Device Performance: The document does not report specific performance metrics (e.g., success rates, complication rates, sensitivity, specificity). The justification for market clearance is that the device is substantially equivalent to a previously approved device.
2. Sample sized used for the test set and the data provenance:
- Not applicable / Not provided. This 510(k) determination is based on a comparison to a predicate, not a clinical study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment, as typically understood for performance studies, is not part of this 510(k) submission type.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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:
- Not applicable / Not provided. This is a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. The "ground truth" for a 510(k) submission of a physical device is its functional similarity and intended use matching that of a predicate device.
8. The sample size for the training set:
- Not applicable / Not provided.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of Document Context:
The provided document is an FDA 510(k) clearance letter for a physical medical device called "FCI Crawford Probe Intubation Sets." The core of a 510(k) submission for such a device is to demonstrate substantial equivalence to a predicate device that is already legally marketed. This process typically involves comparisons of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., biocompatibility, sterility) to show that the new device is as safe and effective as the predicate. It does not generally involve extensive clinical performance studies with acceptance criteria, ground truth establishment, or human-AI interaction studies as would be seen for a software as a medical device (SaMD) or AI-powered diagnostic tool.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are left-aligned.
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
DEC 112008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anne Bohsack Vice President. General FCI Ophthalmics, Inc. P.O. Box 465 76 Prospect Street Marshfield Hills. MA 02051
Re: K991238
Trade/Device Name: FCI Crawford Probe Intubation Sets Regulatory Class: Unclassified Product Code: OKS Dated: April 6, 1999 Received: April 12, 1999
Dear Ms. Bohsack:
This letter corrects our substantially equivalent letter of July 8, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Egleston, ind
Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known):
Crawford Probe Device Name:
Indications For Use:
....
. .
.:
Epiphora in infants or adults, particularly in cases of
canalicular pathologies (stenosis, obstruction or lacerations)
dacryocysorhinostomy (conventional or laser)
imperforation of the nasolacrimal duct in an infant .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashlin Barliave
(Division Sign-Off)
of Ophthalmic Devices
k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
・・。
(Optional Format 1-2-96)
N/A