(21 days)
CuffPatch™ surgical mesh is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.
CuffPatch™ surgical mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. CuffPatch™ surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix is primarily Type I porcine collagen, and is free of cells and cell remnants. The product is supplied sterile in doublelayered peelable packaging.
The provided text describes a 510(k) summary for a medical device called CuffPatch™ Surgical Mesh. It does not contain information about acceptance criteria for a study or a study that proves the device meets such criteria in the way typically expected for an AI/ML device.
Instead, the document details the device's intended use, classification, description, and claims of substantial equivalence to legally marketed predicate devices. The "Performance Data" section briefly states that "Evaluation of the device's materials, physical and performance characteristics revealed that CuffPatch™ is substantially equivalent to the predicate devices, and is suitable for its intended clinical applications." This indicates an assessment was made, but the specific acceptance criteria and the detailed study results are not provided.
Therefore, most of the requested information cannot be extracted from this document, as it outlines a regulatory submission based on substantial equivalence, not a detailed performance study with explicit acceptance criteria.
However, I can extract what is implied about the performance assessment rather than explicit acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary: Substantial equivalence to predicate devices in: | CuffPatch™ is substantially equivalent to: - FortaFlex™ Surgical Mesh (CuffPatch™), K020049 and K011025 - Restore® Orthobiologic Soft Tissue Implant, K031969 |
| - Materials | Evaluation of the device's materials revealed substantial equivalence. CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix (primarily Type I porcine collagen, free of cells and cell remnants). This is similar to predicate devices which are also surgical meshes. |
| - Design | Evaluation of the device's design revealed substantial equivalence. |
| - Physical characteristics | Evaluation of the device's physical characteristics revealed substantial equivalence. |
| - Performance characteristics | Evaluation of the device's performance characteristics revealed substantial equivalence. The device's intended use is for reinforcement of soft tissues during tendon repair and provides a resorbable scaffold. This is similar to predicate devices. The document explicitly states it "is suitable for its intended clinical applications." |
| - Biological attributes | Evaluation of the device's biological attributes revealed substantial equivalence. The device is a resorbable scaffold replaced by the patient's own soft tissue. |
| Secondary (Suitability for Intended Use): Function as intended. | The device's "Evaluation... revealed that CuffPatch™ is substantially equivalent to the predicate devices, and is suitable for its intended clinical applications." Intended Use: Reinforcement of soft tissues repaired by sutures or suture anchors, during various tendon repair surgeries. It reinforces soft tissue and provides a resorbable scaffold. It is not intended to replace normal body structure or provide full mechanical strength; sutures provide biomechanical strength. |
Given the nature of the document as a 510(k) summary for a conventional medical device (surgical mesh), it does not address AI/ML-specific testing methodologies. Therefore, the following points cannot be answered:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document describes a "Performance Data" section but does not detail a study involving test sets in the context of data-driven performance.
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/Not provided. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/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
- Not applicable/Not provided. This is a conventional medical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a conventional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The performance assessment was based on comparing material, physical, performance, and biological characteristics to existing predicate devices, rather than a clinical ground truth in the context of an AI/ML model.
8. The sample size for the training set
- Not applicable/Not provided. No training set is relevant for this conventional device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set is relevant for this conventional device.
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NOV - 2 2004
510(K) Summary
Summary Date: February 25, 2004
| Submitter's | |
|---|---|
| Information: | Organogenesis Inc. |
| 150 Dan Road | |
| Canton, MA 02021 | |
| Phone: 781-401-1110 | |
| Fax: 781-575-0440 | |
| Contact: | Seth Shapiro |
| Manager, Regulatory Affairs | |
| Organogenesis Inc. | |
| Phone: 781-401-1110 | |
| Fax: 781-575-0440 | |
| Device Trade | |
| Name: | CuffPatch™ |
| Device Common | |
| Name: | Surgical Mesh |
| Classification Panel: | General, Restorative and Neurological Devices |
intended Use: CuffPatch™ surgical mesh is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.
CuffPatch™ surgical mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. CuffPatch™ surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Legally Marketed Devices To Which Substantial Equivalence Is Claimed To: CuffPatch™ is equivalent to the FortaFlex™ Surgical Mesh (CuffPatch™), K020049 and K011025, with respect to the materials, design, physical characteristics, performance characteristics and biological attributes. The subject device is also substantially equivalent to the Restore® Orthobiologic Soft Tissue Implant, K031969 in intended use and performance characteristics.
Device Description: CuffPatch™ consists of laminated sheets of porcine intestinal collagen matrix is primarily Type I porcine collagen, and is free of cells and cell remnants. The product is supplied sterile in doublelayered peelable packaging.
Performance Data: Evaluation of the device's materials, physical and performance characteristics revealed that CuffPatch™ is substantially equivalent to the predicate devices, and is suitable for its intended clinical applications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a logo for the Department of Health & Human Services-USA. The logo features a stylized image of three curved lines that resemble a person's profile with their arms outstretched. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
NOV - 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Seth Shapiro Manager, Regulatory Affairs Organogenesis, Inc. 150 Dan Road Canton, Massachusetts 02021
Re: K042809
Trade/Device Name: CuffPatch™ Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: October 8, 2004 Received: October 13, 2004
Dear Mr. Shapiro:
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.
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Page 2 - Mr. Seth Shapiro
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retet 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ KO42809
Device Name: CuffPatch™ Surgical Mesh
Indications for Use:
CuffPatch™ surgical mesh is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.
CuffPatch™ surgical mesh is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. CuffPatch™ surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number__K042809 (Posted November 13, 2003)
§ 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.