(684 days)
The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.
The J-Screw is a two part bone screw for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities. The unique design of the device allows it to fixate or fuse small bones with infinitely adjustable fusing compression, in a fixed yet flexed position.
The provided document is a 510(k) Pre-Market Notification for a medical device called the "J-Screw," a bone fixation fastener. This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a clinical study report with detailed acceptance criteria and performance data for an AI/ML powered device.
Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device meeting acceptance criteria in the context of AI/ML performance metrics cannot be found in this document.
However, I can extract information related to the performance data that was gathered for the J-Screw as outlined in the "Performance Data" section of the 510(k) Summary (Page 4). This data relates to the mechanical properties of the screw, not an AI/ML algorithm's performance.
Here's an attempt to answer based on the available information, noting the significant conceptual difference between the requested AI/ML context and the provided mechanical device document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format typically seen for algorithm performance. Instead, it lists the types of mechanical performance data that were gathered and implies that these met the standards for substantial equivalence to predicate devices. There are no numerical acceptance thresholds or reported performance values provided for these tests in this summary.
| Acceptance Criteria Category (Implied by Test Type) | Reported Device Performance (Not Quantified in this Summary) |
|---|---|
| Insertion Torque | Data gathered as outlined by ASTM F543-13 |
| Removal Torque | Data gathered as outlined by ASTM F543-13 |
| Torsional Yield Strength | Data gathered as outlined by ASTM F543-13 |
| Maximum Torque | Data gathered as outlined by ASTM F543-13 |
| Breaking Angle | Data gathered as outlined by ASTM F543-13 |
| Axial Pullout Strength | Data gathered as outlined by ASTM F543-13 |
| Static Cantilever Bending Force | Data submitted with test outline |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical tests. The data provenance is not mentioned, as these are likely mechanical "bench" tests rather than clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical bone screw, not an AI/ML algorithm requiring expert interpretation for ground truth. The "ground truth" for mechanical properties would be the physical measurement itself.
4. Adjudication method for the test set
Not applicable for mechanical performance 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. The J-Screw is a physical bone fixation device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used
For the mechanical tests, the ground truth would be the direct measurement of physical properties (e.g., torque, strength, angle) as determined by standardized test methods (ASTM F543-13).
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
In summary, the provided document describes a medical device (a bone screw) that is subject to mechanical testing to demonstrate substantial equivalence to existing devices, not an AI/ML powered device. Therefore, most of the requested information, which is relevant to AI/ML device evaluation, cannot be found or fabricated from this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
Competitive Engineering, Incorporated David M. Davis Engineering Manager 3371 East Hemisphere Loop Tucson, Arizona 85706
Re: K130019 Trade/Device Name: J-Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 24, 2014 Received: September 30, 2014
Dear Mr. Davis:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. David M. Davis
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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
K130019 page 1 of 1
J-Screw Intended Use:
The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.
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)
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6. 510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the J-Screw is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | Competitive Engineering, Inc. |
|---|---|
| Address: | 3371 E. Hemisphere LoopTucson, AZ 85706 |
| Contact Person: | David M. Davis |
| Telephone: | 520-746-0270 X-106 |
| Fax: | 520-746-0481 |
| Preparation Date: | November 13, 2014 |
| Device Trade Name: | J-Screw |
| Common Name: | Compression screw |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HWC |
| Regulatory Class;Legally MarketedPredicates: | StayFuse (K990804)FlexFusion Fixation implant (K110445)Nextra Ti Hammertoe Correction System (K122031)Arthrex K-Wire (K052736) |
| Device Description: | The J-Screw is a two part bone screw for use inosteotomy, reconstruction, arthrodesis, joint fusion,fracture repair, and fracture fixation of small bones of theupper and lower extremities. The unique design of thedevice allows it to fixate or fuse small bones withinfinitely adjustable fusing compression, in a fixed yetflexed position. |
| Intended Use: | The J-Screw is indicated for use in osteotomy,reconstruction, arthrodesis, joint fusion, fracture repair,and fracture fixation of small bones of the upper andlower extremities. |
| Performance Data: | Performance data gathered for insertion and removaltorque, torsional yield strength, maximum torque,breaking angle, as well as axial pullout strength wasgathered as outlined by ASTM F543-13 with qualifiedprocesses and material. Performance data gathered forstatic cantilever bending force submitted with testoutline. |
| Conclusion: | The J-Screw possesses the same technologiccharacteristics of the predicate devices. Thesecharacteristics include the intended use, basic threadeddesign, material, size as specified by medicalprofessionals, and fundamental technology. The J-Screwis substantially equivalent to the predicate bone fixationdevices. |
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510(k) Summary of Safety and Effectiveness for the J-Screw continued:
§ 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.