(58 days)
The ParaLock Bone Plates and TUFFNEK™ Bone Screws of the ParaLock Plating System™ are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi- fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients. In addition, the TUFFNEK™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
The ParaLock Plating System™ and TUFFNEK™ screws are lower extremity fixation systems. ParaLock Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. TUFFNEK™ screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the TUFFNEK™ screws when the latter are used for fixation without the plates.
The provided text is a 510(k) Summary for a medical device (ParaLock Plating System™). It describes the device, its intended use, materials, and how it demonstrates substantial equivalence to predicate devices. However, this document describes a traditional medical device (bone plates and screws) and not a software/AI-driven device.
Therefore, most of the requested information regarding acceptance criteria and studies for AI/software performance is not applicable to this document. The concepts of "test set," "training set," "ground truth," "expert consensus," "MRMC studies," "human-in-the-loop performance," or "algorithm-only performance" are specific to the validation of AI/Software as a Medical Device (SaMD) and are not relevant to the mechanical testing of orthopedic implants described here.
The document does provide information relevant to the device's mechanical performance, which serves as its "acceptance criteria" for demonstrating substantial equivalence.
Here's the relevant information that can be extracted, framed within the context of traditional device acceptance:
Device Type: ParaLock Plating System™ (bone plates and screws, mechanical fixation)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards Investigated) | Reported Device Performance |
|---|---|
| ParaLock Plates: | ParaLock Plates: |
| Static bending (according to ASTM F382) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Dynamic bending (according to ASTM F382) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| TUFFNEK™ Screws: | TUFFNEK™ Screws: |
| Torsion (according to ASTM F543) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Insertion/removal (according to ASTM F543) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Pullout (according to ASTM F543) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Technological Characteristics Comparison: | Technological Characteristics Comparison: |
| Performance (as described above) | Same as predicate devices |
| Basic design (screws and plates in various shapes) | Same as predicate devices |
| Material (titanium and/or titanium alloys) | Same as predicate devices |
| Sizes (dimensions comparable to predicate systems) | Comparable to predicate devices |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was a mechanical testing study of "worst-case" configurations of the ParaLock Plates and TUFFNEK™ screws.
2. Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in terms of number of samples, but refers to "worst-case ParaLock Plates" and "worst-case TUFFNEK™ screws." For mechanical testing, this typically refers to a statistically significant number of test articles per configuration to demonstrate compliance with standards.
- Data Provenance: Not explicitly stated, but typically generated in a laboratory setting for medical device testing. No indication of country of origin of data or retrospective/prospective clinical data as it's a mechanical test report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For mechanical testing, "ground truth" is established by adherence to recognized testing standards (ASTM F382, ASTM F543) and the physical properties of the materials and designs, not by human expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments or AI model disagreements, not for objective mechanical test results.
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 device is a mechanical implant, not an AI/software device that would involve human "readers" or be used with AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For this type of device, the "ground truth" is defined by established mechanical testing standards (ASTM F382, ASTM F543) and the corresponding performance characteristics of predicate devices. The goal is to demonstrate that the new device's mechanical performance is equivalent to these benchmarks.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.
In summary, the provided document details the regulatory filing for a mechanical orthopedic implant, not an AI/software medical device. Therefore, the questions related to AI/software validation methodologies (e.g., test/training sets, ground truth establishment by experts, MRMC studies) are not pertinent to this specific submission.
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K140397 page 1 of 2
510(k) Summary
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| Date: | 14 February 2014 |
|---|---|
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Facsimile: (888) 728-1220 | |
| Contact Person: | Frank S. Bono, Chief Technology Officer |
| Trade Names: | ParaLock Plating System ™ |
| Device Classification | Class II |
| Regulations, ProductCodes, Classification& Common Names: | 888.3030, HRS, Single/multiple component metallic bone fixation appliances and accessories, bone plate system |
| 888.3040, HWC, Smooth or threaded metallic bone fixation fastener, bone screw | |
| 888.3030, HTN, Single/multiple component metallic bone fixation appliances and accessories, washer | |
| Device Description: | The ParaLock Plating System ™ and TUFFNEK ™ screws are lower extremity fixation systems. ParaLock Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. TUFFNEK ™ screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the TUFFNEK ™ screws when the latter are used for fixation without the plates. |
| Intended Use: | The ParaLock Bone Plates and TUFFNEK ™ Bone Screws of the ParaLock Plating System ™ are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi- fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients. In addition, the TUFFNEK ™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. |
| Materials: | The ParaLock and TUFFNEK ™ implants are manufactured from medical grade titanium (per ASTM F67) and titanium alloy (per ASTM F136). |
| Predicate Devices: | • The Normed Extremity Titanium Hand and Small Fragment System, the Normed Titanium Calcaneus Plating with Locking Screw System and the Normed Titanium Osteotomy Plating System (Osteomedics Inc - K011118, K022324 and K022325, respectively) |
| • The Wright Medical ORTHOLOC ™ 3Di Hallux System, The Wright Medical ORTHOLOC ™ 3Di Ankle Fusion Plating System and The Wright Medical ORTHOLOC ™ 3Di Midfoot/Flatfoot System (Wright Medical Technology, Inc. - K120359, K121425 and K121651, respectively) | |
| • CHARLOTTE ™ Snap-Off Screw (Wright Medical Technology, Inc. K043583, K050819) | |
| • M3-X Extremity Fixation (OsteoMed Corp., K924018) | |
| • The Arthrex Titanium Opening Wedge Osteotomy System, the Arthrex Small Fragment Plates and Screws, Low Profile Plate and Screw System, the Arthrex Low Profile Screws and The Arthrex Distal Extremity Plate System (Arthrex, Inc. - K032187, K040907, K052614, K103705 and K111253, respectively) |
APR 1 7 2014
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| • The Stryker® Foot Plating System (Howmedica Osteonics - K063875)• The Mini MaxLock Extreme® Plating System (OrthoHelix Surgical DesignsInc. - K101962, K120157 & K121437)• OsteoMed Foot Plating System ("FPS" OsteoMed LP - K091614) | |
|---|---|
| Performance Data: | Mechanical testing of the worst case ParaLock Plates included static anddynamic bending performed according to ASTM F382. Mechanical testing ofthe worst case TUFFNEK™ screws included torsion, insertion/removal andpullout performed according to ASTM F543. The mechanical test results andtheoretical comparisons demonstrated that the mechanical performance of theParaLock Plating System™ and TUFFNEK™ screws is substantiallyequivalent to the predicate devices. |
| TechnologicalCharacteristics: | The ParaLock Plating System™ and TUFFNEK™ screws possess the sametechnological characteristics as one or more of the predicate devices. Theseinclude: |
| • performance (as described above),• basic design (screws and plates in various shapes),• material (titanium and/or titanium alloys) and• sizes (dimensions are comparable to those offered by the predicatesystems). | |
| Therefore the fundamental scientific technology of the ParaLock PlatingSystem™ is the same as previously cleared devices. | |
| Conclusion: | The ParaLock Plating System™ and TUFFNEK™ screws possess the sameintended use and technological characteristics as the predicate devices.Therefore the ParaLock Plating System™ and TUFFNEK™ screws aresubstantially equivalent for its intended use. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Paragon 28, Inc. % Ms. Karen E. Warden, Ph.D. Representative/Consultant BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026-0566
Re: K140397
Trade/Device Name: ParaLock Plating 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, HWC, HTN Dated: March 3, 2014 Received: March 4, 2014
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
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Page 2 - Dr. Karen E. Warden
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm.
Sincerely vours.
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K140397 page 1 of 1
Indications for Use Statement
K140397 510(k) Number:
Device Name: ParaLock Plating System™
Indications for Use:
The ParaLock Bone Plates and TUFFNEK™ Bone Screws of the ParaLock Plating System™ are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.
In addition, the TUFFNEK™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use _ X OR (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
§ 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.