(65 days)
The Phantom Metatarsal Shortening System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include:
Metatarsal and phalangeal osteotomies
Metatarsal deformity correction
Hammertoe
Revision hammertoe
Claw toe
Mallet toe
Proximal Interphalangeal Joint Arthrodesis
Distal Interphalangeal Joint Arthrodesis
The Phantom Metatarsal Shortening System includes a series of titanium (Ti-6Al-4V ELI per ASTM F136) intramedullary implants used for the correction of small bones in the foot. The implants are designed to provide stability and fixation of bone fragments to ultimately achieve fusion.
The provided document is a 510(k) summary for the Phantom Metatarsal Shortening System. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by performance testing. However, it explicitly states that clinical data are not needed to support the safety and effectiveness of the subject device. Therefore, the document does not contain information about a study involving human readers or ground truth determination as described in your request.
The "device" in this context is a medical implant (titanium intramedullary implants), not an AI algorithm or diagnostic tool. The performance testing refers to mechanical and material tests.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested AI/human study details are missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Implied from testing types) | All performance testing conducted for the Phantom Metatarsal Shortening System met the predetermined acceptance criteria. |
| Torque to failure per ASTM F543 | Met acceptance criteria. |
| Insertion and removal torque per ASTM F543 | Met acceptance criteria. |
| Static pullout of threads per ASTM F543 | Met acceptance criteria. |
| Static pullout of the prongs | Met acceptance criteria. |
| Static cantilever bending | Met acceptance criteria. |
| Dynamic cantilever bending testing | Met acceptance criteria. |
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: Not specified. The document only mentions "All necessary testing has been performed on representative Phantom Metatarsal Shortening System components."
- Data provenance: Not applicable. This was mechanical/material testing of physical devices, not clinical data from patients.
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. Ground truth in the context of expert review for AI performance is not relevant to this type of device submission. The "ground truth" for this device would be the physical properties and performance characteristics measured against established ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in clinical studies with human readers, which were not part of this submission. The "adjudication" (if one could even call it that) of the mechanical tests would be the measurement against the ASTM standards.
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. An MRMC comparative effectiveness study was not done. This is a submission for a physical medical implant, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone performance study of an algorithm was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by validated mechanical testing standards (e.g., ASTM F543) and the inherent material properties of titanium (Ti-6Al-4V ELI per ASTM F136). The acceptance criteria are derived from these engineering and material standards.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth establishment process for a physical implant. The design and manufacturing process would be subject to quality control and engineering principles.
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December 16, 2022
Image /page/0/Picture/1 description: The image shows 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 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. Haylie Hertz Senior Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood. Colorado 80112
Re: K223184
Trade/Device Name: Phantom Metatarsal Shortening 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: October 21, 2022 Received: October 24, 2022
Dear Haylie Hertz:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223184
Device Name Phantom Metatarsal Shortening System
Indications for Use (Describe)
The Phantom Metatarsal Shortening System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include:
Metatarsal and phalangeal osteotomies Metatarsal deformity correction Hammertoe Revision hammertoe Claw toe Mallet toe Proximal Interphalangeal Joint Arthrodesis Distal Interphalangeal Joint Arthrodesis
| 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
| 510(k) Number: | K223184 |
|---|---|
| Manufacturer: | Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112 |
| Contact: | Haylie HertzSenior Regulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com |
| Date Prepared: | December 15, 2022 |
| Device Trade Name: | Phantom Metatarsal Shortening System |
| Device Class andCommon Name: | Class II, Screw, Fixation, Bone |
| Classification: | 21 CFR 888.3040: Single/multiple component metallic bonefixation appliances and accessories. |
| Product Codes: | HWC, HTY |
| Indications for Use: | The Phantom Metatarsal Shortening System is indicated foruse in bone reconstruction, osteotomy, arthrodesis, jointfusion, fracture repair and fracture fixation, appropriate forthe size of the device. Specific examples include: |
| ● Metatarsal and phalangeal osteotomies | |
| ● Metatarsal deformity correction | |
| ● Hammertoe | |
| ● Revision hammertoe | |
| ● Claw toe | |
| ● Mallet toe | |
| Proximal Interphalangeal Joint Arthrodesis | |
| Distal Interphalangeal Joint Arthrodesis | |
| Device Description: | The Phantom Metatarsal Shortening System includes a seriesof titanium (Ti-6Al-4V ELI per ASTM F136) intramedullaryimplants used for the correction of small bones in the foot.The implants are designed to provide stability and fixation ofbone fragments to ultimately achieve fusion. |
| Primary PredicateDevice: | Monster Screw System (K203011) |
| Additional Predicate: | HammerTube System (K171715) |
| Reference Devices: | ITS HOL Plate (K131722)Phantom Small Bone Intramedullary Nail System (K182307) |
| SubstantialEquivalence: | The Phantom Metatarsal Shortening System is substantiallyequivalent to the legally marketed predicate devices withrespect to intended use and design. |
| Performance Testing: | All necessary testing has been performed on representativePhantom Metatarsal Shortening System components to assuresubstantial equivalence to its predicate and demonstrate thesubject device performs as intended. All testing wasperformed on finished devices.The device performance was characterized via torque tofailure per ASTM F543, insertion and removal torque perASTM F543, static pullout of threads per ASTM F543, staticpullout of the prongs, static cantilever bending, and dynamiccantilever bending testing.Clinical data are not needed to support the safety andeffectiveness of the subject device. |
| Conclusions: | The Phantom Metatarsal Shortening System subject to thissubmission possess the same intended use and technologicalcharacteristics as the predicate devices. All performancetesting conducted for the Phantom Metatarsal ShorteningSystem met the predetermined acceptance criteria. As such,the Phantom Metatarsal Shortening System is substantially |
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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.