(57 days)
Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.
The SIGN Compression Screw System consists of multiple components; self-tapping compression screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided nonsterile.
The provided document is a 510(k) summary for the SIGN Compression Screw System. It describes the device, its intended use, and a comparison to predicate devices, particularly the ASNIS III Cannulated Screw System (K000080).
Please Note: The document focuses on demonstrating substantial equivalence based on design, materials, and mechanical performance testing. It does not contain information about acceptance criteria for a diagnostic AI device, nor does it describe a study involving human readers, AI assistance, or the creation of ground truth for a diagnostic algorithm.
Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of device (a medical implant, not an AI or diagnostic tool) and a different type of regulatory submission (substantial equivalence for a physical medical device, not performance validation for an AI algorithm).
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided in the context of an AI device. This document describes mechanical testing for a medical implant. The "acceptance criteria" here are implicitly that the device performs equivalently or better than the predicate in terms of mechanical characteristics.
- Reported Device Performance (from "Performance Data (non-clinical)"):
- Axial stiffness
- Load to failure
- Cyclic fatigue
- Outcome: "The results support substantial equivalence and did not raise any issues on the safety or effectiveness of the device."
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. This document describes mechanical testing of a medical device, not an AI algorithm evaluated on a data set. Therefore, there is no "test set" in the context of diagnostic images or data, nor provenance information for such 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)
- Not applicable. This information is for an AI/diagnostic device. The "ground truth" for the mechanical testing would be the physical measurements of the screws themselves, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information is for an AI/diagnostic device.
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
- No. A MRMC study was not done. This study solely focused on the mechanical performance of the physical screws.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This information is for an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of an AI device. For the mechanical testing, the "ground truth" would be the objective physical measurements performed according to established test standards (e.g., ASTM F138).
8. The sample size for the training set
- Not applicable. This document describes mechanical testing of a physical device, not an AI algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is mentioned.
Summary regarding AI aspects:
The provided document is a 510(k) summary for a physical medical implant (SIGN Compression Screw System). It details the device's design, intended use, materials, and non-clinical mechanical performance testing to demonstrate substantial equivalence to predicate devices. It does not contain any information related to AI devices, diagnostic algorithms, or their acceptance criteria or study methodologies. Therefore, most of your questions, which are framed for AI/diagnostic devices, cannot be answered from this text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human face or profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
SIGN Fracture Care International Mr. Robert Schmitt Regulatory Affairs/Quality Assurance Manager 451 Hills Street, Suite B Richland, Washington 99354
Re: K153759
Trade/Device Name: SIGN Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 16, 2015 Received: December 30, 2015
Dear Mr. Schmitt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K153759
Device Name SIGN Compression Screw System
Indications for Use (Describe)
Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for SIGN Fracture Care International. The logo consists of two parts: a stylized figure of a person running in white against a green rectangle on the left, and the word "SIGN" in bold black letters on the right. Below "SIGN" are the words "FRACTURE CARE" in a smaller font size, followed by "INTERNATIONAL" in an even smaller font size.
510(k) Summary
| 510(k) Submitter: | SIGN Fracture Care International451 Hills Street, Suite BRichland, WA 99354 |
|---|---|
| Establishment #: | 3034525 |
| Contact Person: | Robert Schmitt, Regulatory Affairs / Quality Assurance ManagerPhone: 509-371-1107Fax: 509-371-1316E-Mail: Bob.Schmitt@signfracturecare.org |
| Date Prepared: | February 8, 2016 |
| Regulatory Class: | Class II |
| Panel: | Orthopedic |
| Trade Name: | SIGN Compression Screw System |
| Common Name: | Orthopedic Bone Screw |
| Classification Name: | 21CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Device Product Code: | HWC |
Predicate Device: The SIGN Compression Screw System is similar in design, function, and use to the following fixation devices.
Device Description
The SIGN Compression Screw System consists of multiple components; self-tapping compression screws, and a set of surgical instruments. Each implant component is made from Stainless Steel, per requirements in ASTM F138. All implants are single use and provided nonsterile.
Intended Use
Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.
The Indications for Use statement is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for SIGN Fracture Care International. The logo features a green rectangle on the left side with a white figure of a person running. To the right of the rectangle, the word "SIGN" is written in bold, black letters. Below "SIGN" are the words "FRACTURE CARE INTERNATIONAL" in smaller, gray letters.
effectiveness of the device relative to the predicate. Both the subject and predicate devices share the intended use of treating intracapsular femoral neck fractures.
Substantial Equivalence Comparison
The SIGN Compression Screw System is substantially equivalent to the predicate ASNIS III Cannulated Screw System (K000080), in design, performance, functions, and intended use.
The SIGN Hip Construct was included as a predicate because the instruments and implants were cleared under K083582.
Comparison of Technological Characteristics
The predicate and proposed devices have a similar intended use and basic fundamental scientific technology and share the following similarities.
- Similar indications for use
- Similar design features
- Incorporate the same or similar materials
- . Equivalent mechanical performance, based on intended use
The proposed SIGN Compression Screw System has an intended use largely similar to the predicate ASNIS III Cannulated Screw System (K000080). The technical features of the proposed device prompted non-clinical performance testing to ensure substantial equivalence.
Performance Data (non-clinical)
Mechanical testing was performed and three performance characteristics were evaluated:
Axial stiffness, load to failure, and cyclic fatigue. The results support substantial equivalence and did not raise any issues on the safety or effectiveness of the device.
Conclusion
The testing data and design information provided in this submission indicate that the proposed device is substantially equivalent, and performs as well or better than the predicates. This supports the conclusion that the SIGN Compression Screw is substantially equivalent to its predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.