(85 days)
The Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws. The System includes 26 fixation plates and 66 screws, which include all different sizes. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136.
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws used for fractures, fusions, and osteotomies in the hand, wrist, foot, and ankle. The provided documentation primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and performance metrics in the typical sense of a clinical trial or AI algorithm validation.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Darco Locking Bone Plate System (K061808) and OrthoHelix MaxLock Small Bone System (K050868)) | Confirmed through Finite Element Analysis, mechanical testing, and hand calculations. |
| Meets specified requirements for intended use. | Confirmed through Finite Element Analysis, mechanical testing, and hand calculations. |
| Biocompatibility (materials) | All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136, a standard material for implants. |
Explanation: In the context of a 510(k) submission for this type of medical device (fixation plates and screws), the "acceptance criteria" are not typically expressed as specific performance metrics like sensitivity/specificity for a diagnostic device. Instead, the primary acceptance criterion for FDA clearance is demonstrating "substantial equivalence" to a legally marketed predicate device. This involves showing that the device is as safe and effective as the predicate device, often through engineering analyses and mechanical testing, rather than clinical trials with human subjects.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials undergoing engineering analysis and testing. This is not a study involving patient data.
- Data Provenance: The data provenance is from engineering analyses and mechanical tests performed on the device components (plates and screws). This is not retrospective or prospective clinical data from human subjects or countries of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. This submission relies on engineering and material science principles. The "ground truth" for the performance of the device is established by standardized material properties (ASTM F-136) and validated engineering methods (Finite Element Analysis, mechanical testing, hand calculations), rather than expert medical consensus on individual cases.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no "adjudication method" in the sense of reconciling disagreements among experts for a test set of clinical cases. The results of the engineering analyses and mechanical tests are objective and measurable against established engineering standards and predicate device performance.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical implant (hardware), not a diagnostic tool or an AI-assisted system for human interpretation. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study for an algorithm was not done. This device is a physical surgical implant and does not involve any algorithms or artificial intelligence.
7. The type of ground truth used
- Type of Ground Truth: The ground truth used is primarily based on engineering standards, material properties, and comparative mechanical performance against predicate devices' specifications. This includes:
- Standardized material specifications (ASTM F-136 for Ti-6Al-4V ELI titanium).
- Results from Finite Element Analysis (FEA) which provides theoretical mechanical performance data based on established physics and material science.
- Results from physical mechanical testing (e.g., fatigue, static strength) against established benchmarks or predicate device performance.
- Hand calculations, likely referring to standard engineering calculations to assess structural integrity.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no concept of a "training set" in the context of this device submission, as it does not involve machine learning or AI. The design and validation processes are based on engineering principles and material science.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by demonstrating its equivalence to predicate devices through robust engineering analysis and mechanical testing, ensuring it meets safety and effectiveness standards without the need for a training data set.
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K073624 * 1/2
OrthoHelix Surgical Designs, Inc.
Modular Foot System
510(k) Premarket Notification
MAR 2 0 2008
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 1815 W. Market Akron, Ohio 44313 Phone: (330) 869-9582 Fax: (330) 869-9583
Contact Person: Derek Lewis Director of Engineering
Date Prepared: 12/17/07
Name of Device
Modular Foot System
Common or Usual Name
Fixation Plates and Screws
Classification Name
Plate, Fixation, Bone
Predicate Devices
Darco Locking Bone Plate System (K061808) OrthoHelix MaxLock Small Bone System (K050868)
Intended Use
The Modular Foot System is indicated for fractures, fusions and osteotomies of the hand, wrist, foot and ankle in pediatric and adult patients.
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X073604 = 0/0
OrthoHelix Surgical Designs, Inc.
510(k) Premarket Notification
Modular Foot System
Device Description
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws. The System includes 26 fixation plates and 66 screws, which include all different sizes. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136.
Performance Data
Finite Element Analysis, mechanical testing and hand calculations all confirm that the implants within the Modular Foot System are substantially equivalent to its predicate devices, and that it meets the specified requirements for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and a ribbon flowing from its beak. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthohelix Surgical Designs, Inc. % Mr. Derek Lewis 1815 W. Market Akron, OH 44313
MAR 2 0 2008
K073624 Re: Trade/Device Name: Modular Foot System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 6, 2008 Received: March 6, 2008
Dear Mr. Lewis:
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 such 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); 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.
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Page 2 - Mr. Lewis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marti M Millen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): TBD
Device Name: Modular Foot System
Indications for Use:
The Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of
Division of General, Restorative, and Neurological Devices
K073624 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.