(107 days)
The Additive Orthopaedics 3D Printed Bone Segments 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 Additive Orthopaedics 3D Printed Bone Segments are intended for use with ancillary plating fixation.
The Additive Orthopaedics 3D Printed Bone Segments are not intended for use in the spine.
It is a patient specific device.
The Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a simple one piece device constructed individually for each patient using CT image data. It is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The segments are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). It is a patient specific device. The bone segments come in a variety of configurations that depend on the geometry of the application. The surgeon approves the design of the 3D Printed Bone Segments by comparing his/her design requirements to engineering drawings prior to the construction of the implant device.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information about acceptance criteria and studies (such as MRMC, standalone performance, ground truth, sample sizes for training/test sets, and expert qualifications) is not typically found in this type of document because it pertains to the evaluation of AI/ML algorithm performance.
Here's what can be extracted from the document regarding the device's evaluation, rephrased to align with the spirit of the request, focusing on how the device meets the regulatory requirements for "substantial equivalence":
Device Name: Additive Orthopaedics Patient Specific 3D Printed Bone Segments
510(k) Number: K180239
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device submission, there are no "acceptance criteria" in the traditional sense of performance metrics like AUC, sensitivity, or specificity. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device. The "performance" is shown through comparative testing against that predicate.
| Feature/Test | Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Indications for Use | Nearly identical to predicate device. | Verified to be nearly identical to predicate. |
| Material | Identical to predicate device (medical grade titanium alloy (Ti-6AL-4V Eli)). | Verified to be identical. |
| Manufacturing Process | Identical to predicate device (additive manufacturing). | Verified to be identical. |
| Dimensions & Geometry (patient-specific) | Within the range of sizes claimed for the predicate device, developed in a process equivalent to the reference device, and verified by the surgeon. | Demonstrated to meet these conditions. |
| Morphological Characterization | Comparable to predicate device. | Results demonstrated identity to the predicate device. |
| Mechanical Testing (friction, roughness, durability/abrasion, compressive fatigue) | Comparable to predicate device. | Results demonstrated identity to the predicate device. |
| Biocompatibility Testing | Comparable to predicate device. | Results demonstrated identity to the predicate device. |
Study Proving Device Meets Criteria (Substantial Equivalence Study):
The submission highlights a substantial equivalence study based on non-clinical evidence.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable and not provided in the document. The evaluation is based on demonstrating equivalence in materials, manufacturing, indications, and non-clinical performance characteristics (morphological, mechanical, biocompatibility) rather than a "test set" of patient data for an algorithm. The "data" here refers to test results from the device itself and the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. "Ground truth" in the context of an AI/ML device (e.g., expert consensus on medical images) is not relevant for this type of device submission. The verification of the patient-specific design is done by the surgeon.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" in the sense of evaluating diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to this 3D-printed bone segment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical, patient-specific implant, not a standalone algorithm.
7. The type of ground truth used:
The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to AI/ML diagnostic or prognostic devices is not relevant here. For device design, the "ground truth" for the patient-specific geometry is derived from the patient's CT image data and subsequently "verified by the surgeon."
8. The Sample Size for the Training Set:
Not applicable. There is no machine learning "training set" for this device. The device is custom-designed for each patient based on their CT scan data.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The patient-specific designs are generated using individual patient CT image data, and the final design is approved by the surgeon.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Additive Orthopaedics, LLC Gregory Kowalczyk President 83 Amelia Circle Little Silver. New Jersev 07739 May 16, 2018
Re: K180239
Trade/Device Name: Additive Orthopaedics Patient Specific 3D Printed Bone Segments 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: April 13, 2018 Received: April 16, 2018
Dear Gregory Kowalczyk:
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
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801); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director 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) K180239
Device Name
Additive Orthopaedics Patient Specific 3D Printed Bone Segments
Indications for Use (Describe)
The Additive Orthopaedics 3D Printed Bone Segments 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 Additive Orthopaedics 3D Printed Bone Segments are intended for use with ancillary
plating fixation. The Additive Orthopaedics 3D Printed Bone Segments are not intended for
use in the spine.
It is a patient specific device.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary (Per 21 CFR 807.92)
| General Company Information: | Additive Orthopaedics, LLC.Gregory KowalczykPresident83 Amelia CircleLittle Silver, NJ 07739Phone: (732) 882-6633greg@additiveortho.com | ||
|---|---|---|---|
| Date Prepared: | April 12, 2018 | ||
| General Device Information: | |||
| Proprietary Name: | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | ||
| System Classification: | Common Name: Bone Wedge SystemRegulation Name: Single/multiple component metallic bonefixation appliances and accessories;Product Code: HRS- Class II, HWC- Class IIClassification Name and Reference: 21 CFR 888.3030 | ||
| Predicate Devices: | |||
| Company | Product Name | 510K Number | |
| Primary: Additive Orthopaedics, LLC | Bone Wedge System | K153207 | |
| Reference: BioArchitects | Patient Specific Cranial Plate | K151692 | |
| Materialise N.V. | TruMatch CMF Titanium 3DPrinted Implant System | K170272 | |
| Materialise N.V. | Mimics | K073468 |
Description
The Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a simple one piece device constructed individually for each patient using CT image data. It is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The
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segments are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). It is a patient specific device. The bone segments come in a variety of configurations that depend on the geometry of the application. The surgeon approves the design of the 3D Printed Bone Segments by comparing his/her design requirements to engineering drawings prior to the construction of the implant device.
Intended Use (Indications)
The Additive Orthopaedics 3D Printed Bone Segments 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 Additive Orthopaedics 3D Printed Bone Segments are intended for use with ancillary plating fixation.
The Additive Orthopaedics 3D Printed Bone Segments are not intended for use in the spine.
It is a patient specific device.
(a) (6) Technological Characteristics Comparison
The Additive Orthopaedics Patient Specific Bone Segments and the legally marketed predicate device have nearly identical indications, identical materials and identical manufacturing processes. The dimensions and geometry of the subject device, however, are patient-specific. The dimensions and geometry of the Additive Orthopaedics Patient Specific Bone Segments fall within the range of sizes already claimed for the predicate device, are developed in a process equivalent to the reference device, and are verified by the surgeon.
(b) (1) Substantial Equivalence- Non-Clinical Evidence
Morphological characterization, mechanical testing (including, friction, roughness, durability/abrasion, and compressive fatigue) as well as biocompatibility testing were performed on the predicate device and compared to the Additive Orthopaedics Patient Specific Bone Segments. The results of these comparison activities demonstrate that the Additive Orthopaedics Patient Specific Bone Segments are identical to the predicate device identified.
(b) (3) Conclusion- Substantial Equivalence
The Additive Orthopaedics Patient Specific Bone Segments possess the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology. The design characteristics of the subject system do not raise any new types of questions of safety and effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
§ 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.