(26 days)
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
This Special 510(k) submission is intended to address modifications to the predicate Stryker Locking Inserts. The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.
The provided text describes a Special 510(k) submission for a line extension of 3mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter the intended use or fundamental scientific technology. Therefore, the "study" conducted is a demonstration of comparable mechanical and functional properties to predicate devices, rather than a clinical study involving human subjects or AI performance.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the modified device in terms of specific performance thresholds (e.g., minimum tensile strength, fatigue life). Instead, the performance is evaluated in comparison to predicate devices. The implicit acceptance criterion is that the modified device demonstrates comparable mechanical and functional properties to the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Comparable mechanical and functional properties to predicate devices | "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® System to the predicate device K050512, K060514, K060798, and K061012." (Specific test results are not detailed 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)
The document does not specify the sample size used for the mechanical and functional testing. It also does not provide details on data provenance (e.g., country of origin) or whether it was retrospective or prospective, as it pertains to engineering bench testing rather than clinical study 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 question is not applicable to this type of submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices, particularly those involving image analysis or clinical assessments. This submission is for a medical implant (bone plates and screws), and the evaluation is based on engineering principles and mechanical testing, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in clinical ground truth establishment. For mechanical testing, the results are typically quantitative and objective, and do not involve human adjudication in the same way.
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 such study was done. MRMC studies are used to evaluate diagnostic systems, especially those assisted by AI, by comparing the performance of multiple human readers on multiple cases. This submission is for a mechanical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done for the same reasons as above. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed, "ground truth" in the clinical sense is not directly applicable. The "ground truth" for the assessment of this device is based on established engineering standards and direct physical measurements from mechanical and functional testing. The comparable performance to predicate devices serves as the benchmark.
8. The sample size for the training set
This question is not applicable. Training sets are used for machine learning models (AI). This device is a mechanical implant and does not involve any AI components or machine learning.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for an AI model.
In summary:
This 510(k) submission is for a modification to a mechanical implant. The "study" involved mechanical and functional bench testing to demonstrate the modified device's performance is comparable to its predicate devices. Details regarding specific test parameters, sample sizes for testing, or objective acceptance criteria are not provided in this summary, but the overarching conclusion is that comparable performance was demonstrated. The concepts of expert ground truth, adjudication, MRMC studies, or AI algorithm performance are not relevant to this type of device and submission.
{0}------------------------------------------------
KO92419
AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts
Special 510(k)
510(k) Summary of Safety and Effectiveness: AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
For Information contact:
Date Summary Prepared:
Device Identification Proprietary Name:
Common Name: Classification Name and Reference:
Device Product Code:
SEP - 1 2009
Howmedica Osteonics Corp 325 Corporate Drive Mahwah. NJ 07430
Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate. Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116
August 31, 2009
AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030 Smooth or Threaded metallic bone fixation fastener, 21 CFR $888.3040 87 HRS: Plate, Fixation, Bone
87 HWC: Screw, Fixation, Bone
Description:
This Special 510(k) submission is intended to address modifications to the predicate Stryker Locking Inserts.
The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.
Intended Use:
The AxSOS® Locked Plating System Line Extension of 3mm Locking Insert modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.
2092419 Page 1/2
{1}------------------------------------------------
Indications for Use:
The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intented for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
Statement of Technological Comparison:
The subject and predicate devices are made from Stainless Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® System to the predicate device K050512, K060514, K060798, and K061012.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430
SEP - 1 2009
Re: K092419
Trade/Device Name: AxSOS® Locked Plating System (Line Extension of 3mm Locking Inserts) Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II
Product Code: HRS, HWC
Dated: August 4, 2009
Received: August 6, 2009
Dear Ms. Matarese:
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
{3}------------------------------------------------
Page 2 - Ms. Melissa A. Matarese
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Barbara Buchm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): KO92419
Device Name: AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts
Indications For Use:
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
Prescription Use X ·
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Smitta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092419
§ 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.