(198 days)
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant is comprised of a section of mesh with suture tails containing suture barbs for tissue securement. The device and the delivery system are delivered sterile and are for single use only.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study proving the device meets those criteria, as one might find for an AI/ML medical device. The document is a 510(k) summary for a surgical mesh, which is a physical medical device.
The information primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against specific acceptance criteria in a quantitative sense typical of AI/ML evaluation.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) cannot be extracted from this document as they are not relevant to the type of device and submission presented.
However, I can extract the general "performance" information that is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance. | The Refine™ Support System is considered substantially equivalent in performance to the predicate device. |
| Conformance to specifications. | The device conforms to specifications. |
| Meets clinical user needs and intended uses. | The device meets clinical user needs and intended uses. |
| Meets user needs and requirements for performance. | Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance. |
| No new risks or concerns regarding safety or effectiveness. | There are no new risks and concerns regarding safety or effectiveness of the device. |
| Supports reinforcement of soft tissue in plastic/reconstructive procedures. | Indicated for reinforcement of soft tissue in plastic or reconstructive procedures. |
2. Sample sized used for the test set and the data provenance
Not applicable/provided. This document pertains to a physical surgical mesh device, not an AI/ML algorithm that would typically have a "test set" in the computational sense. The "performance evaluations" and "comparison studies" mentioned are likely referring to bench testing and cadaver studies, but specific sample sizes are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided. This is not relevant for this type of device submission.
4. Adjudication method for the test set
Not applicable/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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For this physical device, "ground truth" would relate to the physical and functional properties of the mesh. The document mentions:
- Bench studies: These would likely test mechanical properties, structural integrity, etc. against pre-defined specifications.
- Cadaver evaluations: These would likely assess ease of delivery, tissue securement, and placement in a cadaveric model.
The "ground truth" for these tests would be the established engineering specifications, anatomical accuracy, and successful completion of surgical tasks in a simulated environment.
8. The sample size for the training set
Not applicable/provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable/provided. This is not an AI/ML device.
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lure
CONFIDENTIAL
May not be reproduced, transmitted or disseminated in any form or by ar without the written permission of an authorized representative of Alure Medical
510(k) Summary
MAR - 5 2010
General Information Submitters Name/Address:
Establishment Registration Number:
Alure Medical, Inc. 3637 Westwind Boulevard Suite B Santa Rosa, CA 95403 3007699483 Joseph R. Tamayo (707) 526-4400 main (707) 526-4466 fax (707) 239-1272 cell 18 August 2009
Date Prepared:
Contact Person: Phone Number:
Device Description Trade Name: Generic/Common Name: Classification Name:
Refine™ Support System Surgical Mesh Mesh, Surgical, Polymeric, (21 CFR 878.3300, Product Code FTL)
Predicate Device Information
RefineTM Support System, K083102
Product Description
The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant is comprised of a section of mesh with suture tails containing suture barbs for tissue securement. The device and the delivery system are delivered sterile and are for single use only.
Intended Use
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Substantial Equivalence
Indications
Indications for use of the Refine™ Support System are the same as the predicate device and have been substantiated by performance evaluations and comparison studies.
Technological Characteristics
In establishing substantial equivalence to the predicate device, Alure Medical evaluated the materials, technology, and specifications of the subject and predicate device. The technological characteristics are substantially equivalent.
Performance
The Refine™ Support System is considered substantially equivalent in performance to the predicate device. The device conforms to specifications and meets clinical user needs and intended uses. Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance.
Summary of Safety and Effectiveness
Indications for use, technological characteristics, and performance evaluations of the Refine™ Support System show that the device is substantially equivalent to the predicate device. There are no new risks and concerns regarding safety or effectiveness of the device.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
Alure Medical, Inc. % Mr. Joseph R. Tamayo VP of RAQACA 3637 Westwind Boulevard, Suite B Santa Rosa, California 95403
Re: K092538
Trade/Device Name: Refine™ Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 4, 2010 Received: February 12, 2010
Dear Mr. Tamayo:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Joseph R. Tamayo
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Refine™ Support System Device Name:
Indications for use:
The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krome for MXM
(Division Sign 08)
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K042536 Page 1 of __
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.