(265 days)
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.
The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.
The provided document is a 510(k) summary for the SIGN Hip Construct (SHC). It describes a medical device, specifically a metallic bone fixation appliance, and its submission for regulatory clearance.
This document describes mechanical testing for the device, not a study involving human subjects or AI. Therefore, most of the requested information (related to AI, human readers, experts, ground truth methodologies, etc.) is not applicable.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sufficient strength for static loading modes | Demonstrated sufficient strength |
| Sufficient strength for dynamic compressive loading modes | Demonstrated sufficient strength |
| Sufficient strength for torsional loading modes | Demonstrated sufficient strength |
| Resistance to subsidence | Demonstrated resistance to subsidence |
| Resistance to expulsion | Demonstrated resistance to expulsion |
The document states: "Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results 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
The document does not specify the sample size used for the mechanical testing. It also does not provide details on "data provenance" as this typically refers to patient data, which is not relevant for this type of mechanical engineering study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a mechanical engineering study, not a study requiring expert consensus for ground truth on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a mechanical engineering study, not a study requiring adjudication of expert interpretations.
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, an MRMC study was not done. The device is a physical orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this mechanical study would be established engineering standards and specifications for orthopedic implants (e.g., ASTM standards for material strength, fatigue testing protocols). The reported results indicate that the device met these intrinsic engineering performance metrics.
8. The sample size for the training set
Not applicable. This was a mechanical engineering study; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
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AUG 2 6 2009
510(k) Summary of Safety and Effectiveness SIGN Hip Construct (SHC)
| Contact Information | Classification Name: | Appliance, Fixation, Nail/PlateCombination, Multiple Components |
|---|---|---|
| Doug Donnelly | Common Name: | Hip Fixation System |
| 451 Hills Street, Suite B | Proprietary Name: | SIGN Fin Nail |
| Richland, WA 99354 | Regulatory Class: | Class II, OR, 21 CFR §888.3030 |
| Phone: (509) 371-1107 | Product Codes: | KTT, HSB, HRS |
| Fax: (509) 371-1316 | ||
| signcom@sign-post.org |
Substantial Equivalence Information
The SIGN Hip Construct (SHC) is similar to the following predicate devices:
- SIGN Fin Nail (K043200) .
- Holland Femoral Nail System (K983641) .
- Synthes Locking Stabilization Plate (K052677) �
- Howmedica Omega 3 Trochanteric Stabilization Plate (K081278) ●
- Howmedica T2 Recon Nail (K051624) ●
- Synthes CerviFix (K030377) ●
All of the devices listed above are similar in both their intended use and the basic concept by which they are used. The safety and effectiveness of the SHC is also based on a long history of use of this type of device in the marketplace.
Device Description
The SIGN Hip Construct (SHC) is composed of a Fin Nail Flat (Intramedullary Nail, a Rod Plate, a Rod Connector, an Interlocking Screw, two Compression Screws, a Unicortical Screw and a set of surgical instruments. Each implant component is made from stainless steel, per requirements in ASTM F138.
Indications for Use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.
Performance Data
Mechanical testing was performed on the SHC implant and the results demonstrated sufficient strength for static and dynamic compressive and torsional loading modes and resistance to subsidence and expulsion. The results did not raise any issues on the safety or effectiveness of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Surgical Implant Generation Network (SIGN), Inc. % Mr. Doug Donnelly Manager, Regulatory Affairs 451 Hills Street, Suite B Richland, WA 99354
AUG 2 6 2009
Re: K083582
Trade/Device Name: SIGN Hip Construct (SHC) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HSB, HRS Dated: July 29, 2009 Received: August 4, 2009
Dear Mr. Donnelly:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. Doug Donnelly
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely, yours,
Boban Buchm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083582
Device Name: SIGN Hip Construct (SHC)
Indications For Use: .
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue This does not include femoral neck fractures and may management . include subtrochanteric fractures.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sanita Lo mxm
(Division Sign Off)
(Division Sign-Of Division of Surgical, Orthope and Restorative Devices
510(k) Number K083582
Page 1 of
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.