(87 days)
Synthes Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.
Resorbable Cranial Clamps consist of two disks connected by a ratcheting shaft with an available optional spacer.
This document is a 510(k) summary for the Synthes Resorbable Cranial Clamps, submitted to the FDA in 2002. It primarily establishes substantial equivalence to predicate devices and describes the device's technical specifications and intended use.
Crucially, this document does not contain information about the acceptance criteria or a study that directly proves the device meets specific performance criteria using a quantitative approach commonly seen for AI/software-based medical devices. It's a regulatory clearance document for a physical medical device (resorbable cranial clamps), not an algorithm or diagnostic software.
Therefore, many of the requested categories related to algorithmic performance and clinical study design for such a device (like sample size for test sets, expert consensus, MRMC studies, standalone performance, training sets) are not applicable or not present in this type of document.
Here's an attempt to address the request based only on the provided text, recognizing its limitations for the specific questions posed:
1. A table of acceptance criteria and the reported device performance:
This document does not present specific acceptance criteria or quantitative performance data in the way one would for an AI/software device (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating substantial equivalence to existing legally marketed predicate devices, which implies that the new device performs similarly in terms of safety and effectiveness for its intended use.
| Acceptance Criteria (Implied by 510(k) Process for Physical Devices) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices (in terms of safety, effectiveness, technological characteristics, and intended use) | "Documentation was provided which demonstrated the Synthes Resorbable Cranial Clamp to be substantially equivalent to other legally marketed devices." |
| Indicated for covering burr holes and fixation of cranial bone flaps | "Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps." (Matches intended use of predicate devices) |
| Material properties (Poly(L/DL-lactide)) are comparable to predicate devices for its intended use and resorbability | "MATERIAL: Poly(L/DL-lactide)" (Implied appropriate for application and equivalent to predicate materials) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document. Substantial equivalence for a physical device like this is typically supported by engineering testing, biocompatibility data, and comparison of design features, not specifically a "test set" in the context of diagnostic accuracy.
- Data Provenance: Not specified. This would typically involve bench testing results or potentially pre-clinical animal studies, but the document does not detail these.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The concept of "ground truth" established by experts for a test set is not directly relevant to this type of device clearance. Instead, safety and effectiveness are evaluated based on material science, mechanical testing, and clinical rationale.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/not specified.
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:
- MRMC Study: No, this is not an AI-assisted diagnostic device. This is a physical medical implant. Therefore, MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable in the context of diagnostic accuracy. For a physical device, the "ground truth" relates to its physical and biological performance characteristics (e.g., mechanical strength, biocompatibility, degradation profile, ability to achieve its intended mechanical function) as assessed through engineering studies and comparison to established predicate devices.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
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'JUL 2 9 2002
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 ext. 7191Contact: Matthew M. Hull |
|---|---|
| DEVICE NAME: | Resorbable Cranial Clamps |
| CLASSIFICATION: | Class II, 21 CFR 882.5250: Burr Hole Cover and 882.5360: CranioplastyPlate Fastener. |
| PREDICATE DEVICE: | Documentation was provided which demonstrated the Synthes ResorbableCranial Clamp to be substantially equivalent to other legally marketeddevices. |
| DEVICE DESCRIPTION: | Resorbable Cranial Clamps consist of two disks connected by a ratchetingshaft with an available optional spacer. |
| INTENDED USE: | Resorbable Cranial Clamps are intended for covering burr holes and forfixation of cranial bone flaps. |
| MATERIAL: | Poly(L/DL-lactide) |
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K021408
Trade/Device Name: Synthes Resorbable Cranial Clamps Regulation Number: 882.5250 and 882.5360 Regulation Name: Burr Hole Cover and Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: GXR Dated: May 2, 2002 Received: May 3, 2002
Dear Mr. Hull:
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 application (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 such 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.
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Page 2 - Mr. Matthew M. Hull, RAC
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
R. Mark N. Millikan
elia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
510(k) Number (if known):
Device Name: Resorbable Cranial Clamps
Indications for Use:
Synthes Resorbable Cranial Clamps are intended for covering burr holes and for fixation of cranial bone flaps.
(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 NB
L. Mark N. Millman
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021408
Confidential
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).