(442 days)
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
The Paragon 28 Patient Specific Marking Guides are designed and additively manufactured based on an individual patient's CT scan(s). In surgery, these guides, templates, or anatomical models are used to assist a surgeon in guiding the marking of a bone and/or guiding a surgical instrument for placement (i.e., placing a k-wire). The guides are not used for cutting bone. All guides are patient specific and utilize a CT scanning protocol previously cleared in K180239 (Paragon 28 formerly Additive Orthopaedics). The anatomical landmarks necessary for the design and creation of the Patient Specific Marking Guides must be present and identifiable on computed tomography scan.
The Paragon 28 Patient Specific Marking Guides are additively manufactured from biocompatible nylon (PA 2200 - polyamide 12 white) and produced by laser sintering. The Patient Specific Marking Guides are optional for surgeons to help visualize and plan osteotomies in the foot and ankle and are for single use only.
The provided text is a 510(k) summary for the Paragon 28 Patient Specific Marking Guides. It describes the device, its intended use, and substantial equivalence to a predicate device, supported by various performance tests. However, it does not contain the specific details requested regarding acceptance criteria for device performance, a study proving those criteria were met, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or how ground truth was established for training data.
Therefore, I cannot fulfill your request for that specific information based solely on the provided text.
The closest information provided related to performance is:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria or quantitative reported device performance is provided in the document. The general statement is that "a cadaver lab were conducted to prove the subject device performs in accordance with its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "Cadaver Study" but does not specify the sample size (number of cadavers or cases) or the provenance of the data.
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)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 provided. The device is a physical instrument, not an AI-assisted diagnostic tool, so an MRMC study in this context would be unlikely.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a surgical guide, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the cadaver study, the "ground truth" would implicitly be the actual anatomical marking or instrument placement achieved by the surgeon using the guide, compared to the intended pre-operative plan. However, the specific method of establishing this ground truth (e.g., measurement, expert verification) is not described.
8. The sample size for the training set
This device is designed based on individual patient CT scans. There is no "training set" in the traditional machine learning sense, as it's a patient-specific physical device, not an algorithm being trained. Each guide is custom-made based on one patient's data.
9. How the ground truth for the training set was established
As there isn't a traditional training set, this question is not applicable. The design of each guide is based on the anatomical data from the specific patient's CT scan.
{0}------------------------------------------------
June 28, 2022
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Additive Orthopaedics, LLC % Jan Triani Director QA/RA Paragon 28, Inc. 44 Riverdale Ave Monmouth Beach, New Jersey 07750
Re: K211076
Trade/Device Name: Patient Specific Marking Guides Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: April 8, 2021 Received: April 12, 2021
Dear Jan Triani:
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
{1}------------------------------------------------
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) 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 (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 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,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211076
Device Name Patient Specific Marking Guide
Indications for Use (Describe)
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Paragon 28, Inc. Patient Specific Marking Guides
5. 510K Summary - K211076
1. INRODUCTION
This document contains the 510(k) summary for the Paragon 28, Inc. Patient Specific Marking Guides. The content of this summary is based on Per 21 CFR 807.92
2. SUBMITTER
| Name: | Paragon 28, Inc. |
|---|---|
| Address: | 44 Riverdale AveMonmouth Beach, NJ 07750Phone: (855)786-2828 |
| Official Contact | Jan TrianiRegulatory ConsultantPatient Specific Paragon 28, Inc. |
| Date Prepared: | May 31, 2022 |
| 3. DEVICE INFORMATION: | |
| Trade Name: | Patient Specific Marking Guides |
| Common Name: | Patient specific orthopedic anatomical models,templates, and guides |
| Classification Name: | Orthopaedic Surgical Planning and InstrumentGuides |
| Classification: | 21 CFR 888.3030 |
| Product Code: | PBF |
4. PREDICATE DEVICES
Predicate Device:
-
VSP® Orthopedics System, 3D Systems, Inc. (K190044) .
Reference Device: -
Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC (K180239) ●
-
Vantage PSI System, 3D Systems, Inc. (K193432) .
{4}------------------------------------------------
Paragon 28, Inc. Patient Specific Marking Guides
The predicate devices have not been the subject of any design related recall.
5. DEVICE DESCRIPTION
The Paragon 28 Patient Specific Marking Guides are designed and additively manufactured based on an individual patient's CT scan(s). In surgery, these guides, templates, or anatomical models are used to assist a surgeon in guiding the marking of a bone and/or guiding a surgical instrument for placement (i.e., placing a k-wire). The guides are not used for cutting bone. All guides are patient specific and utilize a CT scanning protocol previously cleared in K180239 (Paragon 28 formerly Additive Orthopaedics). The anatomical landmarks necessary for the design and creation of the Patient Specific Marking Guides must be present and identifiable on computed tomography scan.
The Paragon 28 Patient Specific Marking Guides are additively manufactured from biocompatible nylon (PA 2200 - polyamide 12 white) and produced by laser sintering. The Patient Specific Marking Guides are optional for surgeons to help visualize and plan osteotomies in the foot and ankle and are for single use only.
6. INDICATIONS FOR USE
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot and ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTI S WITH THE PREDICATE DEVICE
Technological Characteristics Comparison
The Patient Specific Marking Guides and the legally marketed predicate devices have similar indications, and manufacturing process. The dimensions and geometry of the Patient Specific Marking Guides are patient specific, utilizing a previously cleared CT scanning protocol. Both the subject and predicate devices' dimensions and geometry are made based on the patient's anatomy.
Substantial Equivalence Non-Clinical Evidence
The intended use and technological characteristics of the subject device are substantially equivalent to the predicate device. The potential impact of a technological difference, for instance polymeric material grade, was addressed by the biocompatibility testing per ISO 10993-1.
8. SUMMARY OF PERFORMANCE TESTING
The testing outlined below was intended to show that the output of the design and development process demonstrated compliance with the device specifications. Biocompatibility testing was conducted to prove the device is not toxic and safe for limited (<24 hours) contact. In addition, a cadaver lab were conducted to prove the subject device performs in accordance with its intended use. The following testing was conducted or referenced for the Patient Specific Marking Guides:
{5}------------------------------------------------
Paragon 28, Inc. Patient Specific Marking Guides
- Sterilization Validation ●
- Equipment Qualification (IQ/OQ/PQ) ●
- Cleaning Validation ●
- Biocompatibility Testing ●
- Cadaver Study ●
- Distribution Testing ●
- Packaging Validation ●
- Aging Study ●
9. CONCLUSION
The Paragon 28 Patient Specific Marking Guides have the identical technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, use of polymeric materials, additive manufacturing process, and fundamental technology. The design characteristics of the subject system raises no new safety and effectiveness questions. From the evidence submitted in this 510(k), the subject devices can be expected to perform the same as the predicate device.
§ 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.