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The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: - Lung resections . - Biopses . - Lobectomies - Gastric banding - Abdominal and thoracic wall repair

The PeriPatch Aegis is intended be used as a surgical patch reinforce surgical staples during material to stapling procedures. The PeriPatch Aegis device assembly consists of a strip of buttress material, a cartridge which mates the device to the endoscopic stapler, and finally a loader which assists the user to place the device on to the stapler.

The provided text does not contain detailed information regarding specific acceptance criteria, a comprehensive study report, or the associated performance metrics in the format requested. The document primarily describes the device, its intended use, and states that "Tissue functional testing was carried out in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh. The test results demonstrate suitable material properties for the indications of the device."

Therefore, I cannot populate the table or answer most of the specific questions.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "Tissue functional testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the study described is "Tissue functional testing" which typically involves laboratory or bench testing of material properties, not human interpretation or a "ground truth" established by experts in the context of imaging or diagnostic devices.

4. Adjudication method for the test set:

• Not applicable as this is not a study involving human interpretation or clinical endpoints requiring adjudication.

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:

• No, a MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-assisted diagnostic or imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. The device is a surgical mesh, not an algorithm.

7. The type of ground truth used:

• For "Tissue functional testing," the "ground truth" would be the established scientific and engineering standards and specifications for surgical mesh materials. These standards are typically based on material science, biomechanics, and ISO/ASTM guidelines for medical devices. The document references "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," implying that the ground truth for performance assessment aligns with these regulatory and scientific guidelines.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:

• Not applicable. This is not a machine learning or AI device.

Summary of Study Information:

• Study Type: Tissue functional testing.
• Purpose: To demonstrate suitable material properties for the device's indications.
• Compliance: Conducted in accordance with "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
• Conclusion: The test results demonstrate suitable material properties.

Missing Information:

The provided text lacks specific details on:

• The exact tests performed (e.g., tensile strength, burst strength, suture retention, biocompatibility).
• The specific quantitative acceptance criteria for each test.
• The quantitative results obtained for the PeriPatch Aegis.
• Sample sizes used for this testing.

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The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

The PeriPatch™ Sheet is a quadrilateral shaped xenograft patch made from a sheet of glutaraldehyde fixed bovine pericardium selected for even thickness. It is designed to repair the body's natural organs and functions like natural tissue. It is intended for intra-cardiac repair procedures. It is identical to other marketed bovine pericardial patches. Extensive quality control procedures assure a consistent, high quality product for clinical use.

This document describes a 510(k) premarket notification for the "PeriPatch™ Sheet," a processed bovine pericardial patch. The submission claims substantial equivalence to previously cleared devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a formalized, quantifiable manner for biological performance. Instead, it demonstrates substantial equivalence to predicate devices through comparisons of physical, chemical, and manufacturing characteristics. The reported device performance is presented as direct comparisons to these predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of a clinical study or a specific, independent dataset used to evaluate the device's performance against defined acceptance criteria. Instead, it relies on comparisons of its physical and performance characteristics to predicate devices. The data provenance is derived from the manufacturing and characterization of the PeriPatch™ Sheet itself and "literature" and "validations" cited in Appendix A and D respectively, which are not provided in this excerpt. This is a retrospective comparison to existing, legally marketed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No independent "test set" with a ground truth established by experts is described. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than an independent clinical validation.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement

No. A MRMC comparative effectiveness study was not done. This is a premarket notification for a medical device (a xenograft patch), not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question applies to AI/ML software, not to a physical medical device like the PeriPatch™ Sheet.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety profiles of the predicate devices, as detailed in their 510(k) clearances and scientific literature. The PeriPatch™ Sheet aims to demonstrate that its characteristics are similar enough to these established devices to be considered substantially equivalent. It is based on engineering and material property comparisons rather than clinical outcomes or pathology data from a new study.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" for this type of device.

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The PeriPatch™ Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for a number of resection techniques including: lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.

PeriPatch™ Sleeve consists of one piece of The qlutaraldehyde fixed bovine pericardium that is sutured into a rectanqular shaped tube. It is intended for reinforcing surgical staples. These specially prepared sleeves are slipped over the forks of linear or endoscopic surgical staplers. Stapling is carried out according to the stapler manufacture's instructions. The suture is removed and the remaining pericardial tissue is withdrawn with the excised host tissue. The sleeves are intended for a number of resection techniques such as lung volume reductions, biopsies, lobectomies and other soft tissue repairs.

The provided document is a 510(k) Premarket Notification for the PM Devices Inc. PeriPatch™ Sleeve. It seeks substantial equivalence to existing predicate devices. However, this document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.

The document focuses on:

• Device Description: What the PeriPatch™ Sleeve is, how it works, and its materials.
• Predicate Devices: Demonstrating similarity to other legally marketed devices (PeriPatch™ Sheet, Glycar Pericardial Patch, Supple Peri-Guard® Pericardium, Vascu-Guard, Supple Peri-Guard).
• Intended Use: Listing the medical conditions and procedures for which the device is intended.
• Technological Characteristics Comparison (Table 4.3): Comparing the PeriPatch™ Sleeve's characteristics (materials, processing, shape, sizes, packaging, tissue thickness, tensile strength, shrink temperature, suture retention, elongation, burst strength, storage solution, rinse instructions, sterility method) to those of the predicate devices. The table consistently lists "SE" (Substantial Equivalence) under the "Significance" column, indicating that these characteristics are considered substantially equivalent to the predicates.
• FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment because this data is not present in the provided text.

The document implies that the device meets acceptance criteria by demonstrating substantial equivalence to predicate devices, particularly through the comparison of physical and performance characteristics in Table 4.3. However, it does not explicitly state acceptance criteria or detail a specific study with sample sizes, expert ground truth establishment, or adjudication methods to "prove" these criteria were met.

Without this information, I cannot fill out the requested table or answer the specific questions about sample sizes, ground truth, MRMC studies, or standalone performance. The absence of this type of detail is common in 510(k) summary documents, which often focus on demonstrating equivalence rather than presenting full study reports.

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The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.

Processed Bovine Pericardial Patch

The provided text is a 510(k) premarket notification letter from the FDA regarding the "PeriPatch™ Sheet." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way a clinical study report or a technical performance assessment would.

The letter explicitly states: "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..."

This means the device's clearance was based on demonstrating substantial equivalence to a predicate device, not necessarily on meeting specific, predefined acceptance criteria through novel performance studies against a set ground truth.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria study or its results.

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