(285 days)
The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
The Conventus PHS™ is an intramedullary device intended to treat proximal humerus fractures. The PHS™ System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
The provided text describes a medical device called the Conventus PHS™ System, an intramedullary device for fixing proximal humerus fractures. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or AI-assisted performance.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical and biocompatibility testing. It outlines the device's physical properties and mechanical performance, not its diagnostic accuracy or the performance of any AI component.
Therefore, I cannot provide details for most of your requested information as it is not present in the provided text.
Here is what I can extract:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or performance metrics related to diagnostic accuracy or AI performance. The pre-clinical tests performed are mechanical and material characterization tests (e.g., static and cyclic axial/bend testing, screw pullout testing, corrosion testing, wear testing, biocompatibility testing, animal testing). The conclusion is simply that "The results demonstrate that the PHS™ System is substantially equivalent to the legally marketed predicate devices," without providing specific numerical acceptance criteria or performance values for these tests.
2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" in the context of diagnostic or AI performance evaluation described. The "testing" refers to mechanical and material characterization of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a diagnostic test set is described.
4. Adjudication method for the test set
Not applicable. No test set adjudication method is described.
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 study or any study involving human readers or AI assistance is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. There is no mention of an algorithm or AI performance.
7. The type of ground truth used
Not applicable. No ground truth for diagnostic or AI performance is established. The "ground truth" equivalent for the pre-clinical tests would be established engineering standards and material properties, but these are not for diagnostic performance.
8. The sample size for the training set
Not applicable. No training set for an AI or diagnostic algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI or diagnostic algorithm is mentioned.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, one behind the other. The faces are oriented to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
April 8, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conventus Orthopaedics, Incorporated Mr. Kent Lind Vice President Quality, Regulatory, Clinical 10200 73td Avenue North, Suite 122 Maple Grove, Minnesota 55369
Re: K141737
Trade/Device Name: Conventus PHS™ System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HRS Dated: March 17, 2015 Received: March 17, 2015
Dear Mr. Lind:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Kent Lind
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 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/Resourcesfor You/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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K141737
Device Name: Conventus PHS™ System
The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
V Prescription Use (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary 5.
| Company: | Conventus Orthopaedics, Inc.10200 73rd Avenue North, Suite 122Maple Grove, MN 55369 |
|---|---|
| Device Trade Name: | Conventus PHST™ System |
| Device Common Name: | Proximal humerus fracture fixation system |
| Contact: | Kent R. LindVice President, Quality, Regulatory, ClinicalPhone: (763) 515-5003Fax: (763) 315-4980 |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798 |
| Date Prepared: | April 3rd, 2015 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3020: Intramedullary fixation rod |
| Class: | II |
| Product Codes: | JDS and HRS |
| Indications for Use: | The Conventus Orthopaedics PHST™ System is indicated for thefixation of proximal humerus fractures except when there are toomany fracture fragments to repair the articular surface. |
| Device Description: | The Conventus PHST™ is an intramedullary device intended to treatproximal humerus fractures. The PHST™ System is a self-expanding implant which is deployed into the medullary canal andprovides a scaffold to which bone fragments are attached usingfragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol. |
| Substantial Equivalence: | Conventus Orthopaedics has demonstrated that, for purposes ofFDA's regulation of medical devices, the Conventus PHST™ System |
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is substantially equivalent to the following devices that have been previously cleared by the FDA:
- · DePuy ACE TiMAX Meta Plate (K983853)
- · Synthes Titanium Cannulated Humeral Nail System (K033071)
- · Conventus Orthopaedics, Inc. DRS™ System (K102689)
This finding is supported by the following pre-clinical tests that have been performed:
- Static and cyclic axial/bend testing
- Static and cyclical torsional testing
- · Screw pullout testing
- · Corrosion testing
- · Wear testing
- Nickel ion release testing
- Surface analysis testing
- Nitinol phase composition
- · Nitinol transition temperature (Af)
- · Biocompatibility testing
- · Animal testing
The results demonstrate that the PHS™ System is substantially equivalent to the legally marketed predicate 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.