(138 days)
The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.
The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.
The Kensey Nash ECM Surgical Patch is a resorbable porcine-peritoneum-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer packages. The product is packaged dry (lyophilized) to be hydrated prior to use.
The provided text is a 510(k) Summary for a medical device, the Kensey Nash ECM Surgical Patch. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to predicate devices rather than establishing new acceptance criteria or conducting studies to prove the device meets these criteria in the same way a novel high-risk device might.
The primary "acceptance criteria" for a 510(k) submission is substantial equivalence to a legally marketed predicate device. This is demonstrated through comparisons of materials, intended use, and technological characteristics, and supported by performance testing.
Therefore, many of the requested categories for AI/clinical study reporting do not directly apply in this context. Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance/Comparison |
|---|---|
| Mechanical Equivalence to Predicate Devices | Tensile Testing: Performed with KN ECM, demonstrated equivalence to legally marketed predicate devices. |
| Suture Retention: Performed with KN ECM, demonstrated equivalence to legally marketed predicate devices. | |
| Biocompatibility (ISO 10993-1:2003 Requirements) | Passed all tests for: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity, and Hemolysis. |
| In Vivo Performance (Tissue Reaction & Defect Repair) | Sheep Model: Defects repaired and evaluated. Results not explicitly detailed beyond "evaluated." (Implied satisfactory for equivalency). |
| Rabbit Study: Performed to evaluate tissue reactions. Results not explicitly detailed beyond "evaluated." (Implied satisfactory for equivalency, passed requirements of all tests). | |
| Overall Substantial Equivalence to Predicate Devices | Performance Testing has confirmed that the Kensey Nash ECM Surgical Patch is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics. The FDA issued a substantial equivalence determination letter (K094061). |
Additional Requested Information (and why some concepts don't apply here)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the mechanical tests, specific sample sizes are not provided. For the in vivo studies, a "sheep model" and a "rabbit study" are mentioned, but the number of animals is not specified.
- Data Provenance: Not specified, but generally, such studies are conducted in a controlled lab or animal facility. The document doesn't mention country of origin or whether the data is retrospective/prospective, as these terms are more typically applied to human clinical data.
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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: This device is a surgical patch, not an AI diagnostic tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data (as described further down) is not established by expert readers interpreting results, but rather through objective measurements (mechanical testing) or histological evaluation (animal studies), which would be done by trained technicians or pathologists. The document does not detail specific expert qualifications for interpreting the mechanical or animal study results.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers, typically in image interpretation or clinical diagnosis. This is not relevant to mechanical or animal biocompatibility testing of a surgical mesh.
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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 a physical medical device (surgical mesh), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing: Ground truth is based on objective, quantitative measurements of material properties (tensile strength, suture retention) compared against established standards or predicate device performance.
- Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1:2003) with biological endpoints (e.g., cell viability for cytotoxicity, skin reaction for sensitization).
- In Vivo Studies: Ground truth is established through histological analysis (for tissue reactions in the rabbit study) and observation/evaluation of defect repair in the sheep model, likely by animal pathologists or researchers.
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The sample size for the training set
- Not Applicable: This is not an AI/machine learning device, so there is no concept of a "training set" in the sense of data used to train an algorithm.
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How the ground truth for the training set was established
- Not Applicable: As above, there is no training set for this type of device.
In summary, the Kensey Nash ECM Surgical Patch demonstrated "acceptance criteria" by showing substantial equivalence to predicate devices through various established mechanical and biocompatibility tests, as well as in vivo animal studies. The device passed the requirements of all tests conducted. This approach is standard for 510(k) premarket notifications.
§ 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.