(48 days)
The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.
The Monster Screw System™ is comprised of bone screws and washers. The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mm diameters (in 0.5 mm increments) having overall lengths from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are offered having a variety of features with respect to head, thread, tip, cannulation and material. Size-matched washers are also available.
This document is a 510(k) summary for the Paragon 28 Monster Screw System™. It describes the device and its intended use, but it does not contain the kind of detailed performance study data you're asking for regarding acceptance criteria, sample sizes, ground truth (which is typically for diagnostic devices), or comparative effectiveness studies.
This submission is for a bone fixation fastener, which is a hardware device, not a diagnostic AI/ML device. Therefore, the questions about "acceptance criteria and study that proves the device meets the acceptance criteria" are typically addressed through mechanical testing and equivalence to predicate devices, rather than clinical performance metrics, ground truth established by experts, or AI-specific study designs like MRMC or standalone performance.
However, I can extract the information that is present and note where the requested information is not applicable or not provided in this type of document.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" in terms of clinical performance metrics, as would be common for diagnostic devices. Instead, the performance is demonstrated through theoretical comparisons to predicate devices for mechanical equivalence.
| Criterion Type | Acceptance Criteria (Not explicitly stated in clinical performance terms, but implied for mechanical equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantially equivalent to predicate devices (implied standard for 510(k) clearance) | "Theoretical comparisons demonstrated the Monster Screw System™ mechanical performance to be substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a mechanical device. The "test set" here refers to theoretical comparisons and bench testing, not a clinical study with a patient sample size.
- Data Provenance: Not applicable. The "theoretical comparisons" would be based on engineering principles and potentially prior testing data of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This is not a diagnostic device where "ground truth" would be established by experts interpreting images or clinical outcomes. The equivalence is based on engineering and material science.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no adjudication needed for mechanical equivalence testing as described here.
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. This is a hardware bone fixation device, not an AI-powered diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device; there is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As noted, "ground truth" as typically defined for diagnostic performance is not relevant for this type of device submission. The "truth" is established through engineering specifications and mechanical testing to demonstrate equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or "ground truth" in this context.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Paragon 28 % Karen Warden, Ph.D. Backroads Consulting, Inc P.O. Box 566 Chesterland, Ohio 44026-0566
Re: K151418 Trade/Device Name: Monster Screw 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: June 16, 2015 Received: June 17, 2015
Dear Dr. Warden:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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" (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.
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 Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Monster Screw System™
Indications for Use (Describe)
The Monster Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 8 – 510(k) Summary
| Date: | 26 May 2015 |
|---|---|
| Sponsor: | Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Facsimile: (888) 728-1220 |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Trade Names: | Monster Screw System™ |
| Device Classification | Class II |
| Classification Name: | Smooth or threaded metallic bone fixation fastener, Single/multiplecomponent metallic bone fixation appliances and accessories |
| Regulation: | 888.3040, 888.3030 |
| Device Product Code: | HWC, HTN |
| Submission Purpose: | This submission addresses modified dimensions of the cleared 2.0Monster Screw components. |
| Device Description: | The Monster Screw System™ is comprised of bone screws and washers.The Monster Screw is a threaded bone screw offered in 2.0mm to 9.5mmdiameters (in 0.5 mm increments) having overall lengths from 8mm (forsmaller diameters) thru 200mm (for larger diameters). The screws areoffered having a variety of features with respect to head, thread, tip,cannulation and material. Size-matched washers are also available. |
| Intended Use: | The Monster Screw System™ is indicated for use in bone reconstruction,osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair andfracture fixation, appropriate for the size of the device. |
| Materials: | The Monster Screw System™ implants are manufactured from medicalgrade titanium alloy (per ASTM F136) and stainless steel alloy (perASTM F2229). |
| Predicate Devices: | Primary: Paragon 28 (K124027)Reference:Vilex Inc (K973309, K991151, K991197 and K014154)OsteoMed Corp. (K924018) |
| Performance Data: | Theoretical comparisons demonstrated the Monster Screw System™mechanical performance to be substantially equivalent to the predicatedevices. |
| TechnologicalCharacteristics: | The Monster Screw System™ possesses the same technologicalcharacteristics as one or more of the predicate devices. These include:performance (as described above), basic design (threaded fastener), material (titanium and/or stainless steel alloys) and sizes (dimensions are comparable to those offered by thepredicate systems). Therefore the fundamental scientific technology of the Monster ScrewSystem™ is the same as previously cleared devices. |
| Conclusion: | The Monster Screw System™ possesses the same intended use andtechnological characteristics as the predicate devices. Therefore theMonster Screw System™ is substantially equivalent for its intended use. |
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§ 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.