(370 days)
The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:
- Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies .
- · Cotton osteotomy
This device is intended for use with ancillary fixation and is not intended for use in the spine.
The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in varying widths and thicknesses to accommodate a variety of small bone applications.
Materials:
PEEK Optima LT1 per ASTM F2026. Titanium alloy per ASTM F136.
Function:
Used for angular correction of gaps and bony voids of small bones in the ankle and foot.
The provided text describes a 510(k) submission for the "Adaptive Wedge" bone fixation device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical studies with acceptance criteria in the traditional sense of AI/software performance.
Therefore, the requested information elements related to AI and software performance, such as sample sizes for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types (pathology, outcomes data), are not applicable to this document as it pertains to a physical medical device.
The study presented here is a non-clinical study involving mechanical testing, not a clinical study on human subjects or an AI/software performance study.
Here's a breakdown of the applicable information:
1. Table of "Acceptance Criteria" and Reported Device Performance:
Since this is a substantial equivalence claim for a physical bone wedge, the "acceptance criteria" are implied by meeting the performance of the predicate devices. The performance is reported through mechanical tests.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Non-Clinical Test Summary) |
|---|---|
| Equivalent static compression strength to predicate devices | Passed static compression testing |
| Equivalent dynamic compression strength to predicate devices | Passed dynamic compression testing |
| Equivalent coefficient of friction to predicate devices | Passed determination of the coefficient of friction |
| Equivalent subsidence and debris generation during static and dynamic compression-shear testing to predicate devices | Passed determination of subsidence and debris generation during static and dynamic compression-shear testing |
| As safe and effective as predicate devices | The conclusions drawn from the comparison between the devices demonstrate that the Adaptive Wedge is as safe, as effective, and performs as well as, or better, than the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the document. The testing refers to mechanical properties of the device itself, not a test set of data.
- Data Provenance: Not applicable in the context of clinical or AI data. The "data" comes from engineering/benchtop mechanical testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. Ground truth, in the context of clinical or AI studies, refers to a definitive diagnosis or outcome. For a physical device, the "ground truth" for mechanical properties would be established through standardized engineering test methods and observed physical characteristics, not expert consensus on medical data.
4. Adjudication Method for the Test Set:
- None. Not applicable to mechanical testing of a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. No clinical studies, let alone MRMC studies, were performed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- No. This is a physical bone wedge, not an algorithm.
7. Type of Ground Truth Used:
- Mechanical Test Results against Predicate Performance. The "ground truth" for demonstrating substantial equivalence was the performance of predicate devices in specific mechanical tests. The Adaptive Wedge's performance in these same tests was then compared to show equivalence.
8. Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set was used.
Summary of Relevant Study Information from the Document:
- Study Type: Non-clinical (mechanical) testing.
- Purpose: To demonstrate substantial equivalence to predicate devices (BIOFOAM™ Bone Wedge, K073535 / K093950).
- Tests Performed:
- Static compression testing
- Dynamic compression testing
- Determination of the coefficient of friction
- Determination of subsidence and debris generation during static and dynamic compression-shear testing
- Conclusion: The tests indicated that the Adaptive Wedge is equivalent to the predicate devices in terms of mechanical safety and performance.
- Clinical Studies: None were performed.
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<110 662
MAR 1 2 2
510(k) Summa for the Adaptive Wedge
In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for the Adaptive Wedge
Date Prepared: March 2, 2011
| 1. Submitter: | Adaptive Specialty LLC |
|---|---|
| 25 NW 23rd PL, STE 6-347 | |
| Portland, OR 97210 | |
| (503) 320-1198 Tele | |
| (413) 618-8941Fax | |
| Contact Person: | J.D. Webb |
| The OrthoMedix Group, Inc. | |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| Telephone: 512-388-0199 |
-
- Trade name: Adaptive Wedge Common Name: Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Product Code: HRS Class II
- ന് Predicate or legally marketed devices which are substantially equivalent: BIOFOAM™ Bone Wedge (K073535 / K093950)
Description of the device: 4.
The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in varying widths and thicknesses to accommodate a variety of small bone applications.
Materials:
PEEK Optima LT1 per ASTM F2026. Titanium alloy per ASTM F136.
Function:
Used for angular correction of gaps and bony voids of small bones in the ankle and foot.
5. Substantial equivalence claimed to predicate devices
The Adaptive Wedge is substantially equivalent to the BIOFOAM™ Bone Wedges in terms of intended use, design, mechanical safety and performance.
6. Intended Use:
The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:
- opening wedge osteotomies of Hallux Valgus .
- · Evans lengthening osteotomies
- · Cotton osteotomy
This device is intended for use with ancillary fixation and is not intended for use in the spine.
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//066.2
se. 2/2
7. Non-clinical Test Summary:
The following tests were conducted:
- . Static compression testing
- . Dynamic compression testing
- . Determination of the coefficient of friction
- Determination of subsidence and debris generation during static and dynamic . compression-shear testing
The results of this testing indicate that the Adaptive Wedge is equivalent to predicate devices.
8. Clinical Test Summary
No clinical studies were performed
9. Conclusions Nonclinical and Clinical
The conclusions drawn from the comparison between the devices demonstrate that the Adaptive Wedge is as safe, as effective, and performs as well as, or better, than the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized representation of a human figure. The figure is composed of three abstract shapes, possibly representing the head, body, and legs, and is oriented towards the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
MAR 1 2 2012
Adaptive Specialty LLC % Mr. J.D. Webb The OrthoMedix Group, Inc 1001 Oakwood Blvd Round Rock, TX 78681
Re: K110662
Trade/Device Name: Adaptive Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS Dated: February 29th, 2012 Received: March 7th, 2012
Dear Mr. Webb:
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.
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Page 2 - Mr. J.D. Webb
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 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,
Per Doth
Mark N. Melkerson Dep Car Dis 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): K110662
Device Name: _ Adaptive Wedge
Indications for Use:
The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:
- Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies .
- · Cotton osteotomy
This device is intended for use with ancillary fixation and is 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110662
§ 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.