(66 days)
The HammerToe Compression System is indicated for use in the stabilization and inter-digital reconstruction of the phalanges of the foot, appropriate for the size of the device.
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerToe Compression System.
The HammerToe Compression System includes two intramedullary bone screws and a strut, which is provided pre-assembled with the proximal screw. Implantable K-wires are also provided in the system. The implants are provided in multiple diameters and lengths to accommodate variations in patient anatomy.
The provided text describes a medical device, the "HammerToe Compression System," and its 510(k) clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical study report.
Instead, the document details physical performance testing of the device to assure substantial equivalence to a predicate device. This type of testing evaluates the mechanical properties of the device itself rather than its performance in detecting or diagnosing a condition, which is what the prompt implies with terms like "accuracy metrics" and "ground truth."
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, reported device performance (in terms of accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or MRMC studies, as this information is not present in the provided text.
Based on the information available, I can only provide the following:
1. A table of acceptance criteria and the reported device performance
The document describes performance testing but does not explicitly state acceptance criteria or provide numerical performance against them for evaluation like sensitivity, specificity, or accuracy. It mentions tests for:
- Static and dynamic bending
- Pullout force
- Insertion/removal torque
- Torque to failure
The conclusion states: "Performance testing demonstrates the substantial equivalence of the HammerToe Compression System to the HammerTube® System." This implies successful completion of these mechanical tests against established benchmarks or comparative performance to the predicate device, but the specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance
The document does not mention the sample size for a "test set" in the context of diagnostic performance. It refers to "representative HammerToe Compression System components" for physical performance testing, implying a hardware test, not a data-driven clinical test. No data provenance (country of origin, retrospective/prospective) is applicable here as it's not a clinical study of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not present in the document. The "ground truth" for this device's evaluation is primarily its mechanical integrity and performance, not a diagnostic outcome requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present.
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
This information is not applicable and not present. The device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical performance testing described, the "ground truth" would be established engineering standards, material specifications, and comparative performance against the predicate device. These are inherent physical properties and test outcomes, not clinical ground truth derived from patients or experts.
8. The sample size for the training set
This information is not applicable and not present. There is no training set mentioned, as this is not a machine learning device.
9. How the ground truth for the training set was established
This information is not applicable and not present.
Summary of what the document does provide regarding device evaluation:
The document describes engineering tests performed on the HammerToe Compression System to demonstrate its "substantial equivalence" to a predicate device (HammerTube® System K171715). These tests focus on the mechanical properties and physical integrity of the implantable components. The intent is to show that the device performs as intended and does not raise new questions of safety and effectiveness compared to the already cleared predicate.
The material of the screws and strut is Titanium Alloy, and K-Wires are Stainless Steel. The system is designed for stabilization and inter-digital reconstruction of the phalanges of the foot.
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January 25, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E., STE 280 Englewood, Colorado 80112
Re: K183228
Trade/Device Name: HammerToe Compression System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: November 14, 2018 Received: November 20, 2018
Dear Mr. Lintula:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2019.01.25, and the time is 11:03:16 -05'00'.
FOR Mark N. 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
510(k) Number (if known) K183228
Device Name HammerToe Compression System
Indications for Use (Describe)
The HammerToe Compression System is indicated for use in the stabilization and inter-digital reconstruction of the phalanges of the foot, appropriate for the size of the device.
The implantable K-wires are indicated for use in the stabilization of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the joint. Additionally, the implantable K-wires are indicated as guide pins for instruments and implants in the HammerToe Compression System.
| 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
| Date: | November 14th, 2018 |
|---|---|
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Fax: (888) 728-1220 | |
| Sponsor contact: | Eric Lintula, Director of Regulatory Affairs |
| Trade Name: | HammerToe Compression System |
| Regulatory Class: | Class II |
| Regulation,Product Code,Classification, andCommon Name: | 888.3040, HWC, Screw, Fixation, Bone888.3040, HTY, Pin, Fixation, Smooth |
| DeviceDescriptions: | The HammerToe Compression System includes twointramedullary bone screws and a strut, which is provided pre-assembled with the proximal screw. Implantable K-wires arealso provided in the system. The implants are provided inmultiple diameters and lengths to accommodate variations inpatient anatomy. |
| Indications forUse: | The HammerToe Compression System is indicated for use in thestabilization and inter-digital reconstruction of the phalanges ofthe foot, appropriate for the size of the device.The implantable K-wires are indicated for use in the stabilizationand fixation of small bones for use in bone reconstruction,osteotomy, arthrodesis, fracture repair and fixation, appropriatefor the size of the joint. Additionally, the implantable K-wiresare indicated as guide pins for insertion of instruments andimplants in the HammerToe Compression System. |
| Materials: | The HammerToe Compression System screws and strut aremade from Titanium Alloy. The K-Wires are manufactured fromStainless Steel. The instrumentation is manufactured frommedical grades of stainless steel, polymer and titanium. |
| PrimaryPredicate: | K171715, Paragon 28, Inc. HammerTube® System |
| AdditionalPredicate: | K130859, Arthrosurface, Inc. Hammertoe Correction System |
| Comparison toPredicateIndications: | The subject HammerToe Compression System andHammerTube® System devices are intended to be used forstabilization of small bones. All indications for the subjectdevice are within the indications of the predicate devices. |
| Comparison toPredicate | Both the subject and the predicate components are designed toachieve stabilization of small bones. In the case of theHammerToe Compression System, the devices thread into the |
| TechnologicalCharacteristics: | medullary cavity of two adjacent small bones and engage witheach other to provide tension and compress the two bonestogether. In the case of the predicate device and the implantableK-wires, the device passes through the medullary cavities of twoadjacent small bones to provide stabilization for compressing thetwo bones together. Differences between the HammerToeCompression implants (material, design, sizes) were shown notto raise new questions of safety and effectiveness. Therefore, thefundamental scientific technology of the HammerToeCompression System is similar to the predicate. |
| PerformanceData: | All necessary testing has been performed on representativeHammerToe Compression System components to assuresubstantial equivalence to its predicate and demonstrate thesubject device performs as intended. All testing was performedon finished devices.The device performance was characterized via static anddynamic bending, pullout force, insertion/removal torque, andtorque to failure testing. Clinical data are not needed to supportthe safety and effectiveness of the subject devices. |
| Conclusion: | Performance testing demonstrates the substantial equivalence ofthe HammerToe Compression System to the HammerTube®System. Therefore, the HammerToe Compression System issubstantially equivalent to the HammerTube® System(K171715) with respect to their indications for use, technicalcharacteristics, and function. |
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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.