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The Biodesign® 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, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, 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 bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers.

The Biodesign® Staple Line Reinforcement device is part of a family of implant devices manufactured from porcine small intestine that are disinfected and processed to remove the tunica mucosa from the inner intestinal surface and tunica muscularis from the outer intestinal surface. The resulting membrane is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Biodesign® Staple Line Reinforcement consists of a thin multi-layer strip of SIS, pre-coated with an adhesive that eliminates the need for a separate adhesive (e.g. hydrogel) to affix the device to surgical stapler jaws. The single-use device is provided on a foam applicator and suspended in a form-fitting tray before being sealed in a foil pouch and sterilized (E-beam). The material composition, general manufacturing processes, packaging configuration and sterilization method of the subject device are identical to the predicate, SURGISIS® SLRTM Staple Line Reinforcement (K070405).

Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

This document is a 510(k) premarket notification decision letter and summary for a medical device called "Biodesign® Staple Line Reinforcement." It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report with specific performance metrics for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, performance data with specific metrics (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

The document discusses:

• Device: Biodesign® Staple Line Reinforcement (a surgical mesh).
• Purpose: Buttressing and reinforcing staple lines during various surgical procedures (lung, gastric, small bowel, colon/colorectal).
• Comparison to Predicate: The core of the submission is to show the device is substantially equivalent to the SURGISIS® SLRTM Staple Line Reinforcement (K070405). The key point is that the subject device is identical to the predicate in materials, manufacturing, intended use, and mode of action, with the only modification being the addition of thinner configurations.
• Performance Data Mentioned:
  • Biocompatibility testing: Leveraged from the predicate device as materials and manufacturing are identical.
  • Non-Clinical testing: "Product verification testing was performed on sterilized finished devices to evaluate the mechanical performance of the subject device for its intended use. Staple line leakage testing confirms that the Biodesign® Staple Line Reinforcement provides adequate staple line buttressing..."

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study details for an AI-driven medical device, as it describes a traditional surgical mesh device seeking 510(k) clearance based on substantial equivalence to an existing product, primarily through material and mechanical performance validation rather than clinical or AI algorithm performance.

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Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.

Kerecis SecureMesh can be used for reinforcement of staple lines during:

• Bariatric surgical procedures
• Colorectal and Colon surgical procedures
• Gastric, small bowels and mesentery procedures
• Lung and bronchus resections

Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.

The provided text is a 510(k) summary for the Kerecis SecureMesh, a surgical mesh. This document describes the device, its intended use, comparison with predicate devices, and performance testing to demonstrate substantial equivalence for regulatory clearance.

However, the questions you've asked are typically relevant to the development and validation of an AI/Machine Learning medical device, particularly concerning diagnostic or interpretative capabilities. The Kerecis SecureMesh is a physical surgical implant, not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets) do not apply to this medical device.

The document describes performance testing for a surgical mesh, which includes:

1. Bench Testing:

   • Biocompatibility (by leveraging prior testing on a similar product).
   • Viral-inactivation evaluation (also leveraged from similar product).
   • Tensile strength comparison with predicate.
   • Usability (loading time, transfer to stapler, ease of use, force to fire, slippage).
   • Performance (leak at staple line, leak pressure, seal burst).

2. Animal Studies:

   • An acute porcine ex-vivo study comparing the Subject Device to a predicate device and un-buttressed stapling (negative control). The conclusion was "no significant difference."

3. Clinical Studies:

   • "No clinical testing was included in this submission." This means no human clinical trials were performed for the 510(k) clearance based on substantial equivalence to predicate devices and the non-clinical testing.

Given the nature of the device and the provided text, I cannot answer the questions about AI/ML device validation. The "acceptance criteria" for this device would be established engineering and performance specifications, and the "proof" is the bench and animal testing demonstrating equivalence to a legally marketed predicate device.

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Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain information about acceptance criteria or a study proving the device meets them, as would be relevant for a diagnostic or AI-powered medical device.

The document is a 510(k) summary for a Surgical Mesh (Veritas Collagen Matrix), which is a physical implant. The approval process for such a device focuses on demonstrating substantial equivalence to a previously approved predicate device, primarily based on technological characteristics and intended use, rather than performance metrics from clinical studies in the same way a diagnostic algorithm would be evaluated.

Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and not present in the provided text for this specific type of medical device approval.

The "Technology/Device Testing" section only states: "The Veritas Collagen Matrix is substantially equivalent to the predicate device in terms of testing." This implies that the testing performed was sufficient to demonstrate substantial equivalence, but it does not detail specific performance metrics or studies in the way requested for a diagnostic AI.

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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

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.

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