(90 days)
The Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimod Silicone Carving Block allows the surgeon to carve a finished device for his own custom uso.
Silicone Carving Blocks
Here's an analysis of the provided text regarding the acceptance criteria and study, focusing on the absence of such information:
The provided document is an FDA 510(k) clearance letter for a "Silicone Carving Block." This letter is an acknowledgment of substantial equivalence to a predicate device, which allows the product to be marketed. It is not a document that details acceptance criteria for performance or a study demonstrating device performance against such criteria.
Therefore, the requested information elements cannot be extracted from this specific document.
To directly answer your request based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not present in the document.
- Reported Device Performance: Not present in the document.
2. Sample size used for the test set and the data provenance:
- This information is not provided because no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided because no ground truth establishment for a performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided because no performance study is described.
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:
- This device is a "Silicone Carving Block," which is a physical material used in surgery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with AI assistance is not applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable, as no performance study requiring ground truth is described.
8. The sample size for the training set:
- Not applicable, as no training set for an algorithm is relevant to this device.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an algorithm is relevant to this device.
Explanation:
A 510(k) clearance letter typically confirms that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness. This process usually involves comparing the new device's specifications, materials, and (if applicable) basic performance characteristics to a predicate, but does not necessarily require de novo clinical studies with acceptance criteria for device performance as would be detailed in a separate clinical study report. The intent of this letter is to permit marketing based on equivalence, not to publish an detailed performance study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. E. J. Smith ·Consultant Silimed, L.C. C/O Smith Associates P.O. Box 4341 Crofton. Maryland 21114
FEB 2 4 1998
Re: K974480 Trade Name: Silicone Carving Block Regulatory Class: II Product Code: MIB Dated: November 26, 1997 Received: November 26, 1997
Dear Mr. Smith:
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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
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Page 2 - Mr. Smith
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.
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,
Celid 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 (lf known):K974480
Device Name: Silimed Silicone Carving Blocks
Classification Panel: MIB
Indications for Use:
The Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimod Silicone Carving Block allows the surgeon to carve a finished device for his own custom uso.
Foderal (U.S.A.) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurronge of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
biolles
(Division Sign-Ofm
Division of General Restorative Devices
510(k) Number_ KG74480
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.