(60 days)
The Surgisis Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.
The Surgisis Stable Line Reinforcement is manufactured from porcine small intestinal submucosa and supplied in nominal strip sizes (unfolded) of 1 x 10.7 cm, 1.2 x 13.2 cm, and 1.2 x 17.3 cm. The device is packaged sterile, sealed double pouches.
Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Cook Biotech Incorporated Surgisis® Staple Line Reinforcement:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standards | Met test requirements, supporting substantial equivalence. |
| Disinfection | Effectively disinfected | Met test requirements, supporting substantial equivalence. |
| Performance Characteristics | Provide reasonable assurance of device performance for intended use. | Met test requirements, supporting substantial equivalence. |
| Substantial Equivalence | Similar to predicate devices in intended use, materials, and technological characteristics. | Determined to be substantially equivalent to predicate devices. |
Note: The document does not explicitly state numerical acceptance criteria. Instead, it refers to meeting test requirements and demonstrating substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set or data provenance for any clinical or performance study that would resemble a "test set" in the context of an AI/ML device. The document describes tests conducted on the material itself ("The material comprising the Surgisis Staple Line Reinforcement was subjected to a panel of tests...").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission. This device is a surgical mesh, not an AI/ML device that generates diagnoses or interpretations requiring expert-established ground truth. The "ground truth" for this medical device would relate to its physical and biological properties.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this type of medical device (surgical mesh). This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI system was not done and is not applicable. This document describes a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Biocompatibility testing: Conforming to ISO 10993-1 standards.
- Disinfection efficacy: Demonstrating effective disinfection.
- Performance characteristics: Meeting mechanical and functional requirements relevant to its intended use as a surgical mesh.
- Comparison to predicate devices: Demonstrating similar intended use, materials, and technological characteristics to legally marketed devices.
These are established through laboratory testing and validated regulatory standards, rather than expert consensus, pathology, or outcomes data in the way an AI diagnostic device would use those terms.
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. A "training set" is typically associated with AI/ML model development, which is not relevant to this device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or AI/ML model development.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The study proving the Surgisis® Staple Line Reinforcement meets its (implied) acceptance criteria is described as a panel of tests conducted on the material itself. These tests assessed:
- Biocompatibility: In accordance with ISO 10993-1 standards.
- Disinfection: To ensure effective sterilization.
- Performance Characteristics: Likely including mechanical properties and structural integrity relevant for its use as a soft tissue reinforcement.
The document states that the "material met the test requirements," providing "reasonable assurance of device performance for its intended use and supporting substantial equivalence." The overall conclusion drawn from these tests was that the device is "substantially equivalent" to existing predicate devices (Surgisis® Soft Tissue Graft, Surgisis® Peripheral Vascular Patch, Peri-Strips® Staple Line Reinforcement-Strip, and Seamguard® Staple Line Reinforcement Material) with respect to intended use and technological characteristics. This substantial equivalence is the primary basis for its 510(k) clearance.
§ 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.