(106 days)
The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The 2.7mm LCP Ulna Osteotomy System consists of two plates, 6- hole and 8-hole which will be available in titanium alloy and stainless steel, to be offered sterile and non-sterile. This system also includes instrumentation which supports transverse and oblique osteotomy cuts as well as plate placement and fixation.
This document describes the 2.7mm LCP Ulna Osteotomy System and its substantial equivalence to predicate devices, rather than a study with acceptance criteria for a device's performance measured against a specific metric. The provided text is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to already legally marketed devices, primarily through design, material, and intended use comparisons, along with bench testing.
Therefore, many of the requested categories in the prompt are not applicable to the information contained in this 510(k) summary. I will address the applicable parts and indicate when information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for a specific clinical or diagnostic outcome as one might find for an AI/ML device or a diagnostic test. Instead, acceptance criteria for this type of submission are typically demonstrating that the device is as safe and effective as the predicate device(s). The "performance" is demonstrated through similarity in design, materials, intended use, and bench testing to confirm mechanical equivalence.
| Aspect of Equivalence/Performance | Acceptance Criteria (Implicit) | Reported Device Performance (as described in the summary) |
|---|---|---|
| Indications for Use | Same or similar indications for use as predicate devices. | "The proposed system has the same indications for use..." Indicated for "fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. For use in adults and adolescents (12-21 years) in which growth plates have fused or will not be crossed by screw fixation." (Matches predicate's scope). |
| Design | Similar in design to predicate devices. | "is similar in design..." Consists of two plates (6-hole and 8-hole) for ulna osteotomy, includes instrumentation for transverse and oblique osteotomy cuts, plate placement, and fixation. |
| Materials | Composed of the same or equivalent materials as predicate devices. | "is composed of the same materials." Available in titanium alloy and stainless steel (materials commonly used in bone fixation devices and likely matching predicates). |
| Fundamental Technology | Incorporates the same fundamental product technology as predicate devices. | "incorporates the same fundamental product technology..." (Implied to be internal bone fixation for the ulna using plates and screws). |
| Mechanical Strength/Integrity | Bending strength and mechanical properties comparable to predicate devices. (Often guided by relevant ASTM or ISO standards for orthopedic implants, though not stated here). | "static and dynamic bench testing was performed as well as calculations comparing the bending strength of the subject and predicate devices based on geometric analyses and material characteristics, defined in standard." (The summary does not provide specific numerical results or comparison values from this testing, only that it was performed to support substantial equivalence). |
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. The device is a bone fixation system, not an AI/ML or diagnostic device that uses a "test set" of patient data. The primary "testing" mentioned is bench testing (mechanical).
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 information is not applicable. There is no mention of "ground truth" established by experts in the context of a test set, as this is a mechanical fixation device, not a diagnostic or AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no "test set" of patient data requiring adjudication in this context.
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 information is not applicable. This is a physical medical device (bone plate and screws), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the typical sense. For mechanical devices, "ground truth" relates to material properties, design specifications, and performance under rigorous bench testing conditions, comparing against established engineering standards and predicate device performance.
8. The sample size for the training set
This information is not applicable. There is no "training set" for this type of medical device submission.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" or corresponding ground truth establishment in this context.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on Available Information):
The "study" proving the device meets the acceptance criteria, in the context of this 510(k) submission, is a demonstration of substantial equivalence to legally marketed predicate devices. This is achieved through:
- Comparative Analysis: The proposed 2.7mm LCP Ulna Osteotomy System was directly compared to predicate devices (K063049- Modular Mini Fragment LCP System and K073228 - DC Ulnar Shortening System).
- Design & Intended Use Parity: The submission asserts that the new system has the same indications for use, is similar in design, and incorporates the same fundamental product technology as the predicate devices.
- Material Equivalence: The device is composed of the same materials (titanium alloy and stainless steel) as the predicate systems, ensuring similar biocompatibility and mechanical properties.
- Bench Testing: To further support substantial equivalence in terms of mechanical performance, static and dynamic bench testing was performed. This testing, combined with calculations comparing the bending strength based on geometric analyses and material characteristics (defined in standard, likely ASTM or ISO standards for orthopedic implants), aimed to demonstrate that the new device's mechanical properties are comparable to or meet the requirements established by the predicate devices or relevant standards.
The success of this "study" is the FDA's determination that the device is substantially equivalent to the predicate devices, meaning it is as safe and effective. The 510(k) summary serves as the evidence for this determination, rather than providing detailed results of a clinical trial or performance study against specific acceptance metrics for AI/ML or diagnostic devices.
{0}------------------------------------------------
KII3364
ﺗ
.
ース
FEB 2 9 2012
510(k) Summary
・
| Sponsor: | Synthes (USA)Rebecca Blank1301 Goshen ParkwayWest Chester, PA 19380(610) 719-1268 |
|---|---|
| Device Name: | 2.7mm LCP Ulna Osteotomy System |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories, HRS |
| Class II, §888.3040 - Smooth or threaded metallic bone fixationfastener, HWC | |
| Predicate Device: | K063049- Modular Mini Fragment LCP SystemK001941- Synthes Modular Foot System (not in comparison table)K073228 - DC Ulnar Shortening System |
| Device Description: | The 2.7mm LCP Ulna Osteotomy System consists of two plates, 6-hole and 8-hole which will be available in titanium alloy andstainless steel, to be offered sterile and non-sterile. This system alsoincludes instrumentation which supports transverse and obliqueosteotomy cuts as well as plate placement and fixation. |
| Intended Use: | The 2.7mm LCP Ulna Osteotomy System is indicated for fixationof fractures, osteotomies, nonunions, replantations, and fusions ofsmall bones and small bone fragments, including osteopenic bonein the ulna. The 2.7mm LCP Ulna Osteotomy System is indicatedfor use in both adults and adolescents (12-21 years) in whichgrowth plates have fused or in which growth plates will not becrossed by screw fixation. |
| SubstantialEquivalence: | Information presented supports substantial equivalence of theSynthes 2.7mm LCP Ulna Osteotomy System to predicate devices.The proposed system has the same indications for use, is similar indesign, incorporates the same fundamental product technology andis composed of the same materials. |
| To additionally support substantial equivalence, static and dynamicbench testing was performed as well as calculations comparing thebending strength of the subject and predicate devices based ongeometric analyses and material characteristics, defined in standard |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Ms. Rebecca Blank 1301 Goshen Parkway West Chester, Pennsylvania 19380
FEB 2 9 2012
Re: K113364 Trade/Device Name: 2.7 LCP Ulna Osteotomy System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: February 7, 2012 Received: February 12, 2012
Dear Ms. Blank:
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 Part 801); medical device reporting (reporting of medical
{2}------------------------------------------------
Page 2 – Ms. Rebecca Blank
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Molkersen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K113364
Device Name: Synthes (USA) 2.7mm LCP Ulna Osteotomy System
Indications for Use:
The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
AND/OR Prescription Use X _ (Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII3364 510(k) Number.
§ 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.