(292 days)
The SMF Ti Alloy Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
The screws are available in 1.5 mm and 2.0 mm diameters, and feature self-drilling, selftapping tips and a square drive recess. The screws are available in 4 mm - 8 mm lengths in 1 mm increments and are manufactured from a titanium alloy.
The provided text is a 510(k) summary for the Synthes SMF Ti Alloy Bone Screws. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices based on mechanical testing. However, this document does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the way you've outlined for clinical performance studies of AI/diagnostic devices.
The 510(k) process for this type of device (bone screws) focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of technological characteristics. It does not typically involve clinical studies with human subjects in the same way that an AI diagnostic tool would.
Here's why your requested information cannot be fully extracted from this document, and what parts can be addressed:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states, "It is our opinion that the SMF Ti Alloy Bone Screws are substantially equivalent to the predicate devices based on mechanical testing." This implies that the acceptance criteria are met if the new device's mechanical properties are comparable to or exceed those of the predicate devices. Specific quantitative criteria (e.g., tensile strength, fatigue life) are not provided in this summary, but would have been part of the full 510(k) submission.
- Reported Device Performance: The summary only states that the equivalence is based on "mechanical testing." No specific performance metrics or their results are reported in this summary.
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 applicable and therefore not present in this 510(k) summary. "Test set" in the context of mechanical testing refers to the number of screws tested, not patient data. The document does not mention any human or clinical data.
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 is not applicable to a mechanical testing study. Ground truth in this context would relate to the accuracy of the mechanical testing equipment and methods, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable to a mechanical testing study.
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 is not applicable. This is a medical device (bone screw), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. This is a medical device (bone screw), not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical testing, the "ground truth" would be established by the measurement standards and physical properties of the materials and devices as determined by laboratory instruments and protocols. It's not clinical "ground truth."
8. The sample size for the training set
- This is not applicable as there is no "training set" in the context of mechanical testing for substantial equivalence for this device.
9. How the ground truth for the training set was established
- This is not applicable as there is no "training set."
Summary Table based on available (and extrapolated) information:
| Criterion Category | Specific Criterion (Implied) | Reported Device Performance (Implied) | Notes |
|---|---|---|---|
| Substantial Equivalence | Mechanical properties (e.g., strength, durability, biocompatibility) are comparable to predicate devices. | "substantially equivalent to the predicate devices based on mechanical testing." | The 510(k) summary asserts that equivalence was demonstrated through mechanical testing. The specific quantitative acceptance criteria (e.g., maximum load, fatigue cycles, torque strength) are not detailed in this summary but would have been part of the full submission comparing the new screws to the Synthes 1.0 mm, 1.3 mm, 2.0 mm, and 2.4 mm bone screws. |
| Material Composition | Manufactured from titanium alloy. | "[Screws] are manufactured from a titanium alloy." | Explicitly stated. |
| Physical Dimensions | Available in 1.5 mm and 2.0 mm diameters; 4 mm - 8 mm lengths. | "[Screws] are available in 1.5 mm and 2.0 mm diameters... 4 mm - 8 mm lengths." | Explicitly stated. |
| Features | Self-drilling, self-tapping tips, square drive recess. | "[Screws] feature self-drilling, self-tapping tips and a square drive recess." | Explicitly stated. |
| Sterility | Provided non-sterile, requires moist heat sterilization prior to use. | "The screws will be provided to the user non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended." | Explicitly stated. |
| Intended Use | For craniofacial and mandibular trauma and reconstruction. | "intended for craniofacial and mandibular trauma and reconstruction." | Explicitly stated. |
In conclusion: This document serves as a 510(k) summary for a medical device (bone screws) seeking market clearance based on substantial equivalence through mechanical testing. It does not involve the type of clinical performance study, use of AI, or human reader assessments that your questions are geared towards. Therefore, most of the specific details you requested regarding sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not present or applicable to this particular submission.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. The logo and the word are both in black, contrasting with the white background. There is a registered trademark symbol to the right of the word.
JUN 24 1997
Attachment I: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact: Angela Silvestri (610) 647-9700 June 1997
The SMF Ti Alloy Bone Screws are compared to Synthes 1.0 mm, 1.3 mm, 2.0 mm and 2.4 mm bone screws , and are intended for craniofacial and mandibular trauma and reconstruction.
The screws are available in 1.5 mm and 2.0 mm diameters, and feature self-drilling, selftapping tips and a square drive recess. The screws are available in 4 mm - 8 mm lengths in 1 mm increments and are manufactured from a titanium alloy.
The screws will be provided to the user non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
It is our opinion that the SMF Ti Alloy Bone Screws are substantially equivalent to the predicate devices based on mechanical testing.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela Silvestri Manager, Requlatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
JUN 2 4 1997
Re: K963546 Trade Name: SMF Titanium (TI) Alloy Bone Screws Regulatory Class: II Product Code: DZL Dated: April 21, 1997 Received: April 21, 1997
Dear Ms. Silvestri:
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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements 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
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Page 2 - Ms. Silvestri
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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,
K. Alvitrust
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
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K963546 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):
SMF Ti Alloy Bone Screws______________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
(
The SMF Ti Alloy Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
(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 Dental, Infection Control,and General Hospital Devices | |||
| 510(k) Number | K963346 | ||
| Prescription Use(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use ______ |
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.