(326 days)
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarbonate polyurethane-urea matrix and standard polyester suture. The Biomerix Surgical Mesh is provided sterile for single use.
The provided text describes a 510(k) summary for the Biomerix Surgical Mesh, which is a medical device. This type of regulatory submission typically focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than establishing specific acceptance criteria and proving performance against them in the same way one might for a novel diagnostic AI algorithm.
Therefore, the information required to populate the requested table and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance of an algorithm) is not present in the provided document. The document details the device's physical and biological characteristics and compares them to predicate devices.
Here's a breakdown of why the requested information cannot be extracted from the given text:
-
Nature of the Device: The Biomerix Surgical Mesh is a physical implant (a non-absorbable mesh). It's not an AI/ML diagnostic or predictive algorithm. Therefore, concepts like "acceptance criteria" based on metrics like sensitivity, specificity, accuracy, or AUC, and studies involving "test sets," "training sets," "ground truth established by experts," "adjudication methods," "MRMC studies," or "standalone (algorithm only) performance" are not applicable to this type of device.
-
Regulatory Pathway (510(k)): A 510(k) submission establishes substantial equivalence. This means the manufacturer shows their device is as safe and effective as a legally marketed predicate device. The performance data section focuses on material testing, bench testing, biocompatibility, and animal testing to demonstrate the material properties and functionality are suitable and comparable to predicates, not that an algorithm performs against a diagnostic criterion.
Based on the provided text, the requested information is not available.
However, I can extract the closest information related to performance and testing:
Acceptance Criteria and Device Performance (Not applicable in the typical AI/ML sense)
| Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance (Focus on material/bench/animal testing) |
|---|---|
| Material Properties suitability for intended use | Material testing performed to demonstrate suitability |
| Meet performance specifications | Bench testing performed; results demonstrate device meets specifications and is acceptable for clinical use |
| Biocompatibility (safety and biostability) | Extensive biocompatibility testing per ISO 10993-1 performed; demonstrates material is safe and biostable |
| Ability to support tissue ingrowth and mechanically reinforce repair | Animal testing demonstrates ability of mesh to support tissue ingrowth and mechanically reinforce repair as compared to surgical controls, without adverse clinical effects |
Study Details (Again, not in the context of an AI/ML algorithm)
- Sample size used for the test set and the data provenance: Not applicable. The "tests" were material, bench, and animal studies. Specific sample sizes and provenance for these different types of non-human studies are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth (e.g., successful ingrowth, mechanical reinforcement, biocompatibility) would be established by standard methods in materials science, biomechanics, and toxicology, reported and interpreted by the relevant scientific and engineering personnel conducting the tests. Expert consensus for interpreting medical images is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- Material properties: Measured values from physical and chemical tests.
- Bench performance: Engineering specifications and measured performance data.
- Biocompatibility: ISO 10993-1 standards and experimental results (e.g., cytotoxicity, sensitization, irritation, implantation effects).
- Animal studies: Histological analysis, mechanical testing of repaired tissue, gross observations from animal models, compared to surgical controls.
- The sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Sponsor:
Biomerix
page 1 of 2
Biomerix Surgical Mesh
K070961
APPENDIX B 510(K) SUMMARY
| Applicant Name: | Biomerix Corporation1700 Rockville Pike, Suite 400Rockville, MD 20852Phone: (301) 998-6152Fax: (301) 984-4368 | FEB 25 2003 |
|---|---|---|
| Contact Person: | Christina L KichulaDirector, RA/QA | |
| Date Prepared: | February 13, 2008 | |
| Device Trade Name: | Biomerix Surgical Mesh | |
| Device Common Name: | Polymeric surgical mesh | |
| Classification Name: | Mesh, surgical, polymeric | |
| Predicate Devices: | DePuy Restore® Orthobiologic Soft Tissue Implant,K031969Artimplant AB Sportmesh™ (K052830)Ethicon Mersilene Polyester Fiber Mesh (pre-amendment)Zimmer Collagen Repair Patch (K053562)Biomerix Vascular Occlusion Device (K043371) | |
| Device Description: | The Biomerix Surgical Mesh is a non-absorbable meshmanufactured from a polycarbonate polyurethane-ureamatrix and standard polyester suture. The BiomerixSurgical Mesh is provided sterile for single use. | |
| Intended Use: | The Biomerix Surgical Mesh is intended for thereinforcement of the soft tissues which are repaired bysuture or suture anchors during rotator cuff repairsurgery.The mesh is not intended to replace normal bodystructure or provide full mechanical strength to supportthe rotator cuff. Sutures used to repair the tear, andsutures or bone anchor systems used to attach thetissue to the bone, provide mechanical strength fortendon repair | |
| Device TechnologicalCharacteristics andComparison toPredicate Device(s): | The Biomerix Surgical Mesh is similar in materials,design, performance and intended use to other surgicalmesh devices.Any differences in the above characteristics have beenadequately tested to support substantial equivalence. | |
| Performance Data: | Material testing was performed to demonstrate that thematerial properties are suitable for the intended use. | |
| Bench testing was performed to demonstrate that thedevices as manufactured meet the performancespecifications. Test results demonstrate that the devicemeets the specifications and is acceptable for clinicaluse. | ||
| Extensive biocompatibility testing per ISO 10993-1 wasperformed to demonstrate that the material is safe andbiostable. | ||
| Animal testing demonstrates the ability of the mesh tosupport tissue ingrowth and mechanically reinforce therepair as compared to surgical controls, without anyadverse clinical effects. | ||
| Conclusion: | Based on the material, biocompatibility, bench, andanimal testing, and the proposed device labeling, theBiomerix Surgical Mesh is substantially equivalent to theidentified predicate devices in terms of intended use,safety, and effectiveness. |
{1}------------------------------------------------
Sponsor:
Biomerix
070961 page 242
Biomerix Surgical Mesh
K070961
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.
FEB 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomerix Corporation % Ms. Christina L. Kichula, RAC Director, RA/QA 1700 Rockville Pike, Suite 400 Rockville, Maryland 20852
Re: K070961
Trade/Device Name: Biomerix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 13, 2008 Received: February 14, 2008
Dear Ms. Kichula:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
{3}------------------------------------------------
Page 2 – Ms. Christina L. Kichula, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Mulhearn
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
APPENDIX A
| Indications for Use | |
|---|---|
| --------------------- | -- |
510(k) Number (if known):
Device Name: Biomerix Surgical Mesh
Indications for Use:
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
Prescription Use × (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)
Selem
Division of General, Restorative, and Neurological Levices
510(k) Number L070921 Page 1 of 1
§ 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.