(123 days)
The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
The Bicortical Fixation Screw & Washer Nut System consists of screws in various diameters and lengths that mate with a washer nut to achieve bicortical fixation.
The provided text describes a medical device, the "Bicortical Fixation Screw & Washer Nut System," and its clearance by the FDA. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and nonclinical (mechanical) testing. It explicitly states, "Clinical data are not needed to support the safety and effectiveness of the subject device."
Therefore, I cannot provide the requested information regarding AI/ML-related acceptance criteria, clinical study details, sample sizes, ground truth establishment, or expert involvement. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices, which this medical device (a bone screw system) is not.
Here's what I can extract based on the type of study described, even though it's not a clinical AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a table with reported performance. Instead, it relies on demonstrating substantial equivalence through nonclinical mechanical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent or superior to predicate devices (Synthes Cortex Screws) | "Side-by-side performance testing demonstrates the substantial equivalence of the Bicortical Fixation Screw & Washer Nut System to the Synthes Cortex Screws." Performance was characterized through: |
| - Torsion testing: Performed on the worst-case Bicortical Fixation Screw & Washer Nut. - Static pullout testing: Performed in bone analog material on the worst-case Bicortical Fixation Screw & Washer Nut. | |
| Material Biocompatibility: Conforms to established standards for permanent implants | "The subject and predicate devices are manufactured from titanium alloy conforming to ASTM F136. This is a material with a long history of biocompatibility and use in previously cleared permanent implants." |
| Design/Function Equivalence: No new issues of safety or effectiveness introduced | "The mechanical testing demonstrates that this minor difference in technology [how compression is achieved] introduces no new issues of safety or effectiveness." Functionally, both aim to achieve compression of fracture fragments. "The Bicortical Fixation Screw & Washer Nut System is substantially equivalent...with respect to its indications for use, material, design, and function." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated numerically. The testing was performed on "test units representative of finished devices." This typically implies a limited number of samples for mechanical testing, not a large patient cohort.
- Data Provenance: The testing was "nonclinical," meaning it was conducted in a lab environment on bone analog material, not on human patients. The country of origin for the testing data is not specified but would likely be the USA where First Ray LLC is located. The study was essentially prospective in terms of the specific devices being manufactured and tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. There was no clinical ground truth established by experts for this nonclinical mechanical testing. The "ground truth" for mechanical testing is derived from established engineering principles and material science standards.
4. Adjudication method for the test set
- This question is not applicable. There was no expert "adjudication" in the sense of clinical review or diagnosis. Mechanical testing results are typically analyzed against predefined engineering specifications.
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 MRMC clinical study was performed, as the device is a bone fixation system and not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's evaluation was mechanical performance data gathered through specific engineering tests (torsion and static pullout) in a bone analog environment, compared against the known performance characteristics of the predicate device (Synthes Cortex Screws). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- This question is not applicable. There was no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- This question is not applicable. There was no "training set" or corresponding ground truth for an AI/ML context.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2016
First Ray LLC Mr. Robert Hov Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K153638
Trade/Device Name: Bicortical Fixation Screw & Washer Nut System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: December 17, 2015 Received: December 18, 2015
Dear Mr. Hoy:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
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) K153638
Device Name
Bicortical Fixation Screw and Washer Nut System
Indications for Use (Describe)
The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the 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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510(k) Summary
| Device Trade Name: | Bicortical Fixation Screw & Washer Nut System |
|---|---|
| Manufacturer: | First Ray LLC124 South 600 West, Suite 100Logan, UT 84321 |
| Contact: | Mr. Robert HoyDirector of ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@surgicalfrontiers.com |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798 |
| Date Prepared: | April 14, 2016 |
| Common Name: | Screw, Fixation, BoneWasher, Bolt Nut |
| Classification: | 21 CFR 888.3040, 21 CFR 888.3030 |
| Class: | II |
| Product Codes: | HWC, HTN |
Indications for Use:
The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
Device Description:
The Bicortical Fixation Screw & Washer Nut System consists of screws in various diameters and lengths that mate with a washer nut to achieve bicortical fixation.
Predicate Devices:
The Synthes Cortex Screws (K112583) and CrossRoads Screw System (K152072) serve as the predicate devices.
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Predicate Comparison:
Indications
The subject and predicate devices are indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. There are no differences in the indications between the subject and predicate devices.
Technological Characteristics
The subject and predicate devices are manufactured from titanium alloy conforming to ASTM F136. This is a material with a long history of biocompatibility and use in previously cleared permanent implants.
Both the subject and predicate constructs are designed to achieve compression of the fracture fragments. In the case of the Bicortical Fixation Screw & Washer Nut, the screw crosses the fracture line, engages with the Washer Nut at the far cortex, and achieves compression of the fracture. In the case of the predicate device, the screw crosses the fracture line, engages with the far cortex, and achieves compression of the fracture. The mechanical testing demonstrates that this minor difference in technology introduces no new issues of safety or effectiveness.
Nonclinical Testing
All necessary testing has been performed for the worst-case Bicortical Fixation Screw & Washer Nut to assure substantial equivalence to its predicates and demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.
The device performance was characterized through torsion and static pullout testing in bone analog material. Clinical data are not needed to support the safety and effectiveness of the subject device.
Conclusion
Side-by-side performance testing demonstrates the substantial equivalence of the Bicortical Fixation Screw & Washer Nut System to the Synthes Cortex Screws. The Bicortical Fixation Screw & Washer Nut System is substantially equivalent to the Synthes Cortex Screws (K112583) and CrossRoads Screw System (K152072) with respect to its indications for use, material, design, and function.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.