(77 days)
The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.
This looks like a 510(k) premarket notification for a medical device: "KSEA Perforated Bioabsorbable Interference Screw MegaFix™". This type of document is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Crucially, 510(k) summaries for devices like this one (bioabsorbable screws for orthopedic fixation) typically do NOT include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the way that an AI/software device would. The assessment for these types of devices focuses on material biocompatibility, mechanical properties, and equivalence to existing devices.
Therefore, many of the requested categories are not applicable to the provided text.
Here's a breakdown of what can and cannot be found in the provided text:
1. Table of acceptance criteria and the reported device performance
- Not applicable/Not found. This 510(k) summary does not contain a table of acceptance criteria or reported device performance in the context of diagnostic accuracy, which is what these questions typically refer to for AI/software devices. The acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through comparison of design, materials, and intended use, and sometimes supported by mechanical testing and biocompatibility data (though not detailed here).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable/Not found. There is no mention of a "test set" in the context of evaluating diagnostic performance or an AI algorithm. The device is a physical implant.
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/Not found. Ground truth establishment by experts is not relevant for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not found. No test set or adjudication method is described.
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/Not found. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not found. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not found. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this device would be its physical and chemical properties and its performance in a mechanical or biocompatibility test, which are not detailed in this summary.
8. The sample size for the training set
- Not applicable/Not found. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable/Not found. No training set ground truth to establish.
Summary regarding the provided document:
The provided text is a 510(k) summary for a physical medical device (Perforated Bioabsorbable Interference Screw). Its clearance is based on "Substantial Equivalence" to legally marketed predicate devices, not on performance against specific diagnostic acceptance criteria related to an algorithm or AI. Therefore, most of the questions stemming from an AI/software device context are not applicable to this document. The document confirms the device's indications for use and states that it is substantially equivalent to predicate devices because its basic features and intended use are similar, and minor differences raise no new issues of safety and effectiveness.
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K030848 pg 191
JUN - 2, 2003 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100 |
|---|---|
| Contact: | Paul S. LeeSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Perforated Bioabsorbable Interference Screw |
| Trade Name: (optional)KSEA Perforated Bioabsorbable Interference Screw MegaFix™ |
Indication: The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
Device Description: The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.
Substantial Equivalence: The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor differences between the KSEA Perforated Bioabsorbable Interference Screw and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device.
Signed:
YYY
Paul S. Lee Senior Regulatory Affairs Specialist
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's focus on health, human services, and well-being. The caduceus is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is simple, using a black and white color scheme.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2003
Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230
Re: K030848
Trade/Device Name: KSEA Perforated Bioabsorbable Interference Screw MegaFix™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 17, 2003 Received: March 17, 2003
Dear Mr. Lee:
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
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Page 2 - Mr. Paul S. Lee
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), 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) you may obtain. 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.
Sincerely yours,
Mark N. Millenson
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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Image /page/3/Picture/0 description: The image is a dark, grainy photograph of a banner or sign. On the right side of the image, there is a logo that says "STORZ Karl Storz Endoscopy". The rest of the image is dark and grainy, with some vertical lines on the left side.
K 03 0848
510(k) Number (if known): Not yet assigned
Device Name: KSEA Perforated Bioabsorbable Interference Screw MegaFix™
I idications for Use: The KSEA Perforated Bioabsorbable Interference Screw, MegaFix" i ; intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ---------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | Yes |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | No |
for Muh N. Milkenor
(Division Sign-Off)
드 바 등 등 문 및 문 로 바 높 공 뉴 뉴 로 바 로 드 뉴 버 트 트 님 용 트 브 스 트 바
(Optional Format 1-2-96)
Division of General, Restorative
and Neurological Devices
510(k) Number K030848
003
N/A