(126 days)
Synthes CSC is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
The CSC is contraindicated in the following situations: in patients with a skull thickness less than 4 mm; or when the gap surrounding the bone flap is greater than 2 mm.
The CSC is MRI Compatible.
Synthes Cranial Spring Clip (CSC) is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The CSC has a T-profile, which consists of two semi-circular tabs, and two projections that are bent into springs to lodge in the diploe of the cranial bone surrounding the osteotomy. The two tabs are 0.2 mm thick and rest on the superior surfaces of the cranial flap and the surrounding cranial bone. The CSC has a low profile, is 11.5 mm in length, 9.0 mm in width, and is 4.2 mm in height (0.2 mm above the cranial surface). 1.5 mm Ti Alloy Bone Screws will be inserted laterally through the CSC and into the diploe. The CSC is for single use only.
This document is a 510(k) summary for the Synthes (USA) Cranial Spring Clip (CSC), a medical device intended to reattach cranial bone flaps. This type of document does not typically contain the detailed acceptance criteria or results of a study proving the device meets specific performance metrics in the way an AI/ML device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be answered directly from the provided text. I will provide information based on what is available and indicate where the information is not present.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. A 510(k) notification focuses on substantial equivalence to a predicate device, rather than explicit performance acceptance criteria and results from a clinical study as would be typical for an AI/ML device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. The document does not describe a test set or data provenance in the context of device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present. This summary does not mention a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present.
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 information is not present. The device is a physical medical implant, not an AI/ML algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. The device is a physical medical implant, not an AI/ML algorithm, so "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not present. As it's a physical device, the concept of "ground truth" for algorithmic performance isn't applicable in this context. The safety and effectiveness are typically demonstrated through mechanical testing, biocompatibility, and clinical experience with similar predicate devices.
8. The sample size for the training set
This information is not present. This device is not an AI/ML algorithm, so there is no "training set."
9. How the ground truth for the training set was established
This information is not present. This device is not an AI/ML algorithm, so there is no "training set" or ground truth for it.
Summary based on the provided document:
The provided document is a 510(k) summary for a physical medical device (Synthes Cranial Spring Clip). Its purpose is to demonstrate "substantial equivalence" to a predicate device (Synthes Midfacial System, K953806), rather than providing detailed performance metrics from a de novo clinical study with acceptance criteria. As such, the information typically requested for AI/ML device studies (test sets, training sets, ground truth establishment, expert adjudication, MRMC studies) is not found in this type of submission.
The document describes the device's physical characteristics, intended use, and contraindications. It states that the device is "MRI compatible." The FDA's review confirms substantial equivalence, allowing the device to be marketed, subject to general controls and good manufacturing practice regulations.
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Summary of Safety and Effectiveness Information [510(k) Summary]
MAR | 6 1998
2974206
| SUBMITTER | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Sheri L. Musgnung |
|---|---|
| COMMON OR USUALNAME | Plate, Cranioplasty, Preformed, Alterable; Fastener, Plate, Cranioplasty |
| DEVICECLASSIFICATION | Class II, 21 CFR 882.5320 and 882.5360 |
| PREDICATE DEVICE | Synthes Midfacial System (K953806) |
| DESCRIPTION | Synthes Cranial Spring Clip (CSC) is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The CSC has a T-profile, which consists of two semi-circular tabs, and two projections that are bent into springs to lodge in the diploe of the cranial bone surrounding the osteotomy. The two tabs are 0.2 mm thick and rest on the superior surfaces of the cranial flap and the surrounding cranial bone. The CSC has a low profile, is 11.5 mm in length, 9.0 mm in width, and is 4.2 mm in height (0.2 mm above the cranial surface). 1.5 mm Ti Alloy Bone Screws will be inserted laterally through the CSC and into the diploe. The CSC is for single use only. |
| INTENDED USE | Synthes CSC is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. |
The CSC is contraindicated in the following situations: in patients
with a skull thickness less than 4 mm; or when the gap surrounding
the bone flap is greater than 2 mm.
The CSC is MRI compatible.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1998
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes USA 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K974206 Synthes (USA) Cranial Spring Clip Regulatory Class: II Product Codes: GWO and HBW Dated: February 13, 1998 Received: February 17, 1998
Dear Ms. Musgnung:
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 The general controls provisions of the Act 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 Requlations, 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 Requlation (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 In addition, FDA may publish further announcements action. 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.
Image /page/1/Picture/9 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread.
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Page 2 - Ms. Sheri L. Musgnung
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) 594-4659. 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement:
K974206 510(k) Number (if known):
Synthes (USA) Cranial Spring Clip (CSC) Device Name: ...
Indications For Use:
Synthes CSC is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
The CSC is contraindicated in the following situations: in patients with a skull thickness less than 4 mm; or when the gap surrounding the bone flap is greater than 2 mm.
The CSC is MRI Compatible.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
signature
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K974206
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).