(86 days)
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
· Cotton (opening wedge) osteotomies of the medial cuneiform
· Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra Titanium Bone Wedges are not intended for use in the spine.
The Integra® Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure, and are offered in a variety of sizes and shapes to correct various skeletal deformities in the foot. The Integra® Titanium Bone Wedges are intended to be used with ancillary plating fixation.
The provided context refers to a 510(k) Pre-market Notification for a medical device called the "Integra® Titanium Bone Wedge." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria like those used for AI/ML-driven diagnostic devices.
Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as typically applied to AI/ML diagnostic tools, is not applicable to this device.
The "study" conducted for this medical device is focused on mechanical and biocompatibility testing to demonstrate that it is safe and performs comparably to a legally marketed predicate device.
Here's an analysis based on the provided text, addressing the relevant points and explaining why others are not applicable:
1. A table of acceptance criteria and the reported device performance
Not Applicable in the context of an AI/ML diagnostic device with performance metrics like sensitivity/specificity.
For the Integra® Titanium Bone Wedge, the "acceptance criteria" are not reported as specific numerical thresholds like those for AI performance. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (BIOFOAM™ Bone Wedge, K093950) through:
- Similar design features, materials, and intended use.
- Successful completion of specific mechanical and biocompatibility tests.
The reported device performance is summarized as:
"The results of these verification activities demonstrate that the Integra Titanium Bone Wedges are safe for the intended use, and are substantially equivalent to the predicate device identified."
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 in the context of an AI/ML diagnostic device.
For this mechanical device:
- Sample Size: The document does not specify the exact number of Integra® Titanium Bone Wedges used for each mechanical or biocompatibility test. It simply states that "Mechanical testing, including expulsion, abrasion, static compression, and compressive fatigue, as well as biocompatibility testing were performed."
- Data Provenance: The data would originate from laboratory testing of the physical devices, not clinical data from patients. Therefore, country of origin or retrospective/prospective nature of data are irrelevant.
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. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a mechanical bone wedge, "ground truth" is established by engineering standards and validated laboratory test methodologies. There are no "experts establishing ground truth for a test set" in the sense of medical diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods are used in scenarios where multiple experts might disagree on the "ground truth" for a diagnostic label. This is not relevant to mechanical or biocompatibility testing.
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. MRMC studies are specific to evaluating diagnostic devices, typically AI-assisted imaging tools, and their impact on human reader performance. This device is a surgically implanted bone wedge, not a diagnostic tool, and therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This refers to AI algorithm performance. The Integra® Titanium Bone Wedge is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable in the AI/ML sense.
For this device, "ground truth" equates to:
- Engineering Standards: Established benchmarks for mechanical strength, fatigue, and material properties.
- Biocompatibility Standards: Regulations and tests (e.g., ISO 10993 series) to ensure the material is safe for implantation and does not elicit adverse biological responses.
These are determined by established scientific and regulatory guidelines, not clinical expert consensus on diagnostic labels.
8. The sample size for the training set
Not Applicable. There is no "training set" for a mechanical device in the AI/ML sense. The device itself is manufactured, and then samples are taken for testing.
9. How the ground truth for the training set was established
Not Applicable. (As above, no training set in this context).
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510(K) SUMMARY
Integra® Titanium Bone Wedge
Submitter's name and address:
Ascension Orthopedics 8700 Cameron Road Austin, TX 78754 USA
Contact person and telephone number:
Kyla Kara Associate, Regulatory Affairs Telephone: 609.936.6926 Facsimile: 609.275.9445
AUG 07 2013
Date Summary was prepared:
May 9, 2013
Name of the device:
| Proprietary Name: | Integra® Titanium Bone Wedge |
|---|---|
| Common Name: | Bone Wedge |
| Classification Name: | Plate, Fixation, Bone (21CFR §888.3030, Product Code HRS)Screw, Fixation, Bone (21CFR §888.3040, Product Code HWC) |
| Classification Panel: | Orthopedic |
Substantial Equivalence:
The Integra® Titanium Bone Wedge is substantially equivalent in function and intended use to the predicate device detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K093950 | HRS; HWC | BIOFOAM™ BoneWedge | Wright MedicalTechnology, Inc. |
Device Description:
The Integra® Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure, and are offered in a variety of sizes and shapes to correct various skeletal deformities in the foot. The Integra® Titanium Bone Wedges are intended to be used with ancillary plating fixation.
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Indications for Use:
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- · Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra® Titanium Bone Wedges are not intended for use in the spine.
Substantial Equivalence Comparison:
Components of the Integra Titanium Bone Wedge are similar in design and materials to the predicate device, BIOFOAM™ Bone Wedge (K093950).
Testing and Test Results:
Mechanical testing, including expulsion, abrasion, static compression, and compressive fatigue, as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Integra Titanium Bone Wedges are safe for the intended use, and are substantially equivalent to the predicate device identified.
Conclusion:
The design features, material, and intended use of the Integra® Titanium Bone Wedges are substantially equivalent to the predicate device. BIOFOAM™ Bone Wedge (K093950). The safety and effectiveness of the Integra® Titanium Bone Wedge is adequately supported by the substantial equivalence information, materials information, and performance data provided within this Premarket Notification submission.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The image is likely a header or title for a document or website related to the Department of Health & Human Services.
Public Ficalth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2013
Ascension Orthopedies Ms. Kyla Kara Associate, Regulatory Affairs 8700 Cameron Road Austin, Texas 78754
Re: K131360
Trade/Device Name: Integra® Titanium Bone Wedge 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: July 19, 2013 Received: July 22, 2013
Dear Ms. Kara:
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 cither 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 complics 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
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Page 2 – Ms. Kyla Kara
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.
Erin I. Keith
For
Mark N. Melkerson IDirector Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131360
Integra® Titanium Bone Wedge Device Name:
Indications For Use:
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
· Cotton (opening wedge) osteotomies of the medial cuneiform
· Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra Titanium Bone Wedges are not intended for use in the spine.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 1 of l
vii
Page 51 of 265
§ 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.