(14 days)
Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton.
Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
Synthes Automated Tack Driver is designed for use with Synthes Resorbable Tacks. Resorbable Tacks provide fixation and aid in the alignment and stabilization of craniofacial bones when used in conjunction with Resorbable Fixation System plates and meshes. To facilitate tack insertion into a predrilled hole in bone, the Self-Retaining Tack Driver previously cleared has been modified for more controlled and repeatable insertion force. A compression spring has been added to the design, which upon release allows automatic tack insertion into a pre-drilled hole in bone.
This document is a 510(k) summary for the Synthes Automated Tack Driver, an accessory to the Synthes Resorbable Tack System. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving their fulfillment:
Analysis:
The provided text is a 510(k) summary and the accompanying FDA clearance letter. It is not a study report or a document that details performance testing with specific acceptance criteria and results.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective as a legally marketed device. While a 510(k) typically includes performance data to support this claim, the summary provided here only gives a high-level description of the device and its intended use. It does not contain the detailed information required to answer most of your questions about specific acceptance criteria and a study demonstrating compliance.
The critical sentence "A compression spring has been added to the design, which upon release allows automatic tack insertion into a pre-drilled hole in bone" suggests a modification from a manual to an automated process. This modification would likely necessitate performance testing (e.g., insertion force, repeatability, consistency) to ensure the automated driver performs as intended and is equivalent to the predicate. However, those test details are not present in this document.
Therefore, many of your requested items cannot be extracted from the provided text.
Here's what can be stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from the text. The document does not specify any quantitative acceptance criteria or reported performance metrics for the Synthes Automated Tack Driver (e.g., specific insertion force ranges, success rates, or repeatability measures).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from the text. The document does not mention any sample sizes for testing or details about data provenance.
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)
- Not applicable/Cannot be provided from the text. This type of information is relevant for studies involving diagnostic image interpretation or complex clinical assessments. The Synthes Automated Tack Driver is a mechanical surgical instrument; its performance would likely be assessed through engineering and mechanical testing, not by expert interpretation of clinical "ground truth" in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided from the text. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. This is unlikely to be relevant for the mechanical testing of a tack driver.
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
- Not applicable/Cannot be provided from the text. This is relevant for AI-powered diagnostic devices. The Synthes Automated Tack Driver is a mechanical surgical instrument and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Cannot be provided from the text. This question also pertains to AI/algorithm performance. The Synthes Automated Tack Driver is a physical device, and its "standalone" performance would typically refer to its mechanical function, not an algorithm's.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Cannot be provided from the text. As explained, the concept of "ground truth" as it applies to diagnostic or prognostic studies is not directly applicable to a mechanical surgical instrument. Performance would be measured against engineering specifications (e.g., force, precision, durability).
8. The sample size for the training set
- Not applicable/Cannot be provided from the text. This question relates to machine learning models. The Synthes Automated Tack Driver is a mechanical device, not an AI/ML system, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided from the text. As above, this pertains to AI/ML systems and is not relevant for this device.
Summary:
The provided 510(k) summary and FDA letter confirm the clearance of the Synthes Automated Tack Driver based on substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or the specifics of the study (including sample sizes, ground truth establishment, or expert involvement) that would have been conducted as part of the full 510(k) submission to demonstrate the device meets those criteria. Such details would typically be found in the comprehensive testing reports submitted to the FDA, not in the public 510(k) summary.
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MAY 1 6 2002
3. 510(k) Summary:
| Submitter | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Bonnie Smith(610) 647-9700 |
| Name of the Device | Synthes Automated Tack Driver(An accessory to Synthes Resorbable Tack System) |
| Predicate Device | Synthes Resorbable Tack System, Self-Retaining Tack Driver -K000560 |
| Device Description | Synthes Automated Tack Driver is designed for use with SynthesResorbable Tacks. Resorbable Tacks provide fixation and aid in thealignment and stabilization of craniofacial bones when used inconjunction with Resorbable Fixation System plates and meshes. Tofacilitate tack insertion into a predrilled hole in bone, the Self-Retaining Tack Driver previously cleared has been modified formore controlled and repeatable insertion force. A compressionspring has been added to the design, which upon release allowsautomatic tack insertion into a pre-drilled hole in bone. |
| Intended Use | Synthes Resorbable Tack System is intended for fractures of thecraniofacial skeleton including, but not limited to, comminutedfractures of the naso-ethmoidal and infraorbital areas, comminutedfractures of the frontal sinus wall, and midfacial fractures; andreconstructive procedures of the midface or craniofacial skeleton.Synthes Resorbable Tack System is not intended for use in themandible or other full load-bearing situations, for areas with activeinfection or for patient conditions including blood supply.limitations, insufficient quantity or quality of bone, or latent infections. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P. O. Box 1766 Paoli, Pennsylvania 19301
Re: K021382
Trade/Device Name: Synthes (USA) Automated Tack Driver Regulation Number: 872.4760 and 882.5330 Regulation Name: Bone Plate and Preformed Nonalterable Cranioplasty Plate Regulatory Class: II Product Code: JEY and GXN Dated: April 30, 2002 Received: May 2, 2002
Dear Ms. Smith:
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
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Page 2 - Ms. Smith
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.
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,
Patricia Cicerata Kfor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. Indications for Use
Special 510(k) Device Modification
INTENDED USE STATEMENT
510(k) Number (if known):
Device Name:
Indications
Synthes Automated Tack Driver (An accessory to Synthes Resorbable Tack System)
Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton.
Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
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Subject (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices XIXI3K
510(k) Number ________________________________________________________________________________________________________________________________________________________________
(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 |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
CONFIDENTIAL Synthes (USA) Special 510(k): Automated Tack Driver for Synthes Resorbable Tack System
§ 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.