(37 days)
The Synthes 1.0/1.2 mm Plusdrive Screws are intended for fracture fixation in hand surgery and neurosurgery.
The 1.0/1.2 mm Plusdrive Screws are either self-drilling or self-tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.
The provided document is a 510(k) summary for the Synthes 1.0/1.2 mm Plusdrive Screws. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/software device performance evaluation.
Therefore, the requested information categories related to AI/software device performance (such as sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, and expert qualifications for ground truth) are not applicable to this type of medical device submission.
Here's an attempt to answer the applicable parts based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, or physical/mechanical thresholds). Instead, the crucial "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing legally marketed predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The document states, "Documentation is provided which demonstrates that the Synthes 1.0/1.2mm Plusdrive Screws are substantially equivalent to other legally marketed devices." The FDA letter confirms the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
| Intended Use | The device is intended for "fracture fixation in hand surgery and neurosurgery." This matches the general intended use of similar bone fixation fasteners. |
| Device Description (features consistent with predicate) | The device is described as "either self-drilling or self-tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths." This description implies functional similarity to the predicate devices. |
| Classification (consistent with predicate) | Classified under 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener, which aligns with the predicate device's classification. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a physical medical device (screws), not an AI/software device. The concept of a "test set" with data provenance as understood in AI/ML performance studies does not apply here. The submission relies on comparative analysis with predicate devices and, likely, bench testing and material characterization data which are not detailed in this summary.
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. There is no "ground truth" to be established by experts for a test set in the context of an AI/ML study for this physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process as defined for AI/ML performance evaluation.
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. This device is not an AI-assisted diagnostic or clinical decision support tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a physical device's substantial equivalence is typically established through a comparison of technological characteristics, materials, mechanical properties, and intended use to existing legally marketed devices, rather than clinical "outcomes data" or "expert consensus" in the AI/ML sense.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A horizontal line runs beneath the word, emphasizing the brand name. The logo and text are clear and easily readable.
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:
OCT 7 - 2004
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| ----- | ---------------- | ------------- |
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes 1.0/1.2 mm Plusdrive Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener |
| Predicate Device: | KLS Martin 1.0mm Center-Drive Screw SystemSynthes Maxillofacial Titanium Micro Set |
| Device Description: | The 1.0/1.2 mm Plusdrive Screws are either self-drilling or self-tapping, have a flat head profile with rounded edges with acruciform recess, and are available in various lengths. |
| Intended Use: | The Synthes 1.0/1.2 mm Plusdrive screws are intended for fracturefixation in hand surgery and neurosurgery. |
| SubstantialEquivalence: | Documentation is provided which demonstrates that the Synthes1.0/1.2mm Plusdrive Screws are substantially equivalent to otherlegally marketed devices. |
| The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head facing left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301
Re: K042356
Trade/Device Name: Synthes (USA) 1.0/1.2 mm Plusdrive Screws Regulation Number: 21CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 27, 2004 Received: August 31, 2004
Dear Ms Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreativent of 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 I ou may, dierely missus 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 11 your de room 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 sct 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 -- Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) rremarket 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
Mark Millman
Celia 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
510(k) Number (if known):
Device Name:
Synthes (USA) 1.0/1.2 mm Plusdrive Screws
Indications for Use:
The Synthes 1.0/1.2 mm Plusdrive Screws are intended for fracture fixation in hand surgery and neurosurgery.
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K042356 |
N/A