(134 days)
The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes Low Profile Neuro System consists of titanium plates, meshes, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.
Based on the provided documents, the Synthes Low Profile Neuro System is a medical device, and the information given pertains to its 510(k) premarket notification to the FDA. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study in the way a new drug or novel medical device might.
Therefore, many of the requested categories for a study proving device performance are not applicable in this context. The provided text describes a regulatory clearance process, not a clinical or performance study with detailed acceptance criteria and expert reviews.
Here's a breakdown of what can be extracted and what is not applicable:
- A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance / Outcome |
|---|---|
| Primary Acceptance Criteria | |
| Substantial Equivalence to Predicate Device | Documentation provided established substantial equivalence to other legally marketed devices. |
| Indications for Use | Intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. (This is taken from the "Indications for Use" statement, not a performance criterion, but a key regulatory approval aspect). |
| Device Description (Materials) | Plates & Meshes - Titanium; Screws - Titanium Alloy. (This is a factual description, not a performance metric). |
Explanation for "Reported Device Performance": In a 510(k) submission for a device like this, the "performance" is primarily demonstrated through substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. The document states "Documentation was provided which demonstrated the Synthes Low Profile Neuro System to be substantially equivalent to other legally marketed devices." It does not report quantitative performance metrics (e.g., tensile strength, fatigue life, or clinical success rates) against specific numerical acceptance criteria within these documents.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The provided submission documents do not describe a "test set" in the context of a clinical performance study. The substantial equivalence determination relies on comparisons to predicate devices and potentially bench testing data or existing clinical literature on similar devices, but not a specific clinical "test set" with a defined sample size as would be used in a randomized controlled trial.
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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):
- Not applicable. There is no mention of a "test set" or "ground truth" establishment by experts in the context of a performance study in these documents. The "experts" involved are likely the regulatory reviewers at the FDA and the engineers/scientists at Synthes who conducted the equivalence analysis and prepared the submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or independent adjudication method is described.
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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. This device (Synthes Low Profile Neuro System) is a hardware implant (plates, meshes, screws for cranio-facial procedures), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance metrics are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. See point 5. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Given that this is a 510(k) clearance based on substantial equivalence, the "ground truth" is established through the regulatory process comparing the device's design, materials, and intended use against already approved predicate devices. There's no clinical trial "ground truth" derived from patient outcomes or pathology described in these documents.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI or machine learning device requiring model training.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
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3. Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Matthew M. Hull(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes Low Profile Neuro System |
| Device Classification(s) | Class II, §872.4760 -- Plate, Fixation, BoneClass II, §882.5250 - Burr Hole CoverClass II, §872.4880 - Screw, Fixation, Intraosseous |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes LowProfile Neuro System to be substantially equivalent to other legallymarketed devices. |
| Device Description | The Synthes Low Profile Neuro System consists of titanium plates,meshes, and screws in a variety of shapes and sizes designed forvarious cranio-facial procedures. |
| Indications | The Synthes Low Profile Neuro System is intended for use in selectivetrauma of the midface and craniofacial skeleton; craniofacial surgery;reconstructive procedures; and selective orthognathic surgery of themaxilla and chin. |
| Material | Plates & Meshes - TitaniumScrews - Titanium Alloy |
CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 NOV
Mr. Matthew Hull Regulatory Affairs SYNTHES (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301-1222
Re: K022012
Trade/Device Name: Synthes Low Profile Neuro System Regulation Number: 872.4760, 872.4880 and 882.5250 Regulation Name: Bone Plate, Rotary Scaler and Burr Hole Cover Regulatory Class: II Product Code: JEY Dated: October 7, 2002 Received: October 15, 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 vour 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.
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Page 2 – Mr. Hull
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 594-4613. 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 yours,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.
510(k) Number (if known):
Device Name:
Indications for Use:
ia
Synthes Low Profile Neuro System
The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
(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
Susan Kunz
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number:
umber: k02012
CONFIDENTIAL Synthes(USA) Synthes Low Profile Neuro System 510(k)
1004
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.