(189 days)
Histofreezer is indicated for use in the treatment of the following: Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana
Not Found
This document is an FDA 510(k) clearance letter for the Histofreezer® Verruca Plana, a cryosurgical device. As such, it does not contain the detailed information about acceptance criteria, study design, and performance metrics typically found in a clinical study report or a premarket approval (PMA) application.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence determination means that the FDA has agreed, based on the sponsor's submission (which would have included comparative performance data), that the new device is as safe and effective as a device already on the market. However, the letter itself does not provide the specifics of those studies.
Therefore, I cannot provide the requested information from the given text. The document is a regulatory approval, not a scientific study report.
To answer your request, if this were a hypothetical scenario where this document provided performance data relevant to AI/ML device approval, here's how I would approach it, highlighting why the current document is insufficient:
Based on the provided text, I cannot extract the specific acceptance criteria, study design, or performance metrics in the format requested. The document is a 510(k) clearance letter, which states that the device, Histofreezer® Verruca Plana, has been found "substantially equivalent" to a predicate device. It does not contain the detailed study results, acceptance criteria, or experimental setup typically required to answer the questions about device performance and validation.
Here's a breakdown of why each point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present. A 510(k) submission would include performance data demonstrating equivalence to a predicate, but the clearance letter itself doesn't report these details.
- Sample size used for the test set and the data provenance: Not mentioned in the clearance letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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: This device (Histofreezer) is a cryosurgical tool, not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study for AI assistance is not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, the provided FDA 510(k) clearance letter serves as a regulatory approval document and does not contain the detailed technical and clinical study information required to answer your specific questions regarding acceptance criteria and performance data. Such information would typically be found in the 510(k) submission itself, which is not provided here.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
R. Sam Niedbala, Ph.D., BCFE .Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799
OCT 21 1997
Re: K971392 Trade Name: Histofreezer® Verruca Plana Regulatory Class: II Product Code: GEH Dated: September 15, 1997 Received: September 16, 1997
Dear Dr. Niedbala:
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 requirements , 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 - R. Sam Niedbala, Ph.D., BCFE
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,
Aisellfo
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Histofreezer® Verruca Plana _____________________________________________________________________________________________________________________________________
Indications For Use: Histofreezer is indicated for use in the treatment of the following:
Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
colly
(Division) Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
c:\fda\indica.doc
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.