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The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.

The proposed device is a self-expanding, two-layered polypropylene mesh containing an extruded monofilament PET polymer "ring". The top layer of polypropylene mesh has two slits in it to form pockets. The purpose of the pockets is to facilitate placement, positioning and fixation of the device. The mesh is constructed from knitted polypropylene monofilament. The monofilament PET "ring" adds stability to the device facilitating placement and assurance in the proper placement of the patch. A single layer of expanded polytetrafluoroethylene (ePTFE) is attached to the polypropylene mesh. The attachment is accomplished with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge (excluding the off-center opening) of the polypropylene mesh is heat sealed to the ePTFE layer. An off-center opening in the proposed device accommodates the stoma and this opening is surrounded by an ePTFE collar. The ePTFE collar is attached to the mesh side of the proposed device with an interlocking stitch using PTFE monofilament. A slit in the proposed device extends from the opening in the proposed device to the perimeter to facilitate positioning of the proposed device around the stoma. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.

The provided document describes the Bard CK Parastomal Hernia Patch (K042026) and its comparison to predicate devices for 510(k) clearance. The focus of the performance data section is on biocompatibility and bench testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device evaluations.

Here's an analysis based on the provided text, addressing the requested information where possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical test set with human subjects or a dataset for AI/ML evaluation. The "tests" mentioned are biocompatibility and bench tests performed on the device itself. Therefore, sample sizes and data provenance in the context of human data are not applicable here.

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

Not applicable. Ground truth as typically defined for AI/ML device evaluation (e.g., expert consensus on medical images or patient outcomes) is not mentioned or required for this type of device and submission.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process as no clinical or image-based test set needing expert review is used.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh; the evaluation focuses on its physical and biological properties rather than its effectiveness in aiding human readers with diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on established industry standards and regulatory requirements for biocompatibility and mechanical/material properties of surgical meshes. For biocompatibility, this would involve standardized in vitro and in vivo tests to assess cytotoxicity, sensitization, irritation, etc. For bench testing, it refers to pre-defined specifications for material strength, flexibility, porosity, and other physical attributes relevant to its function as a hernia patch.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. See point 8.

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The Bard CruraSoft Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of chest wall defects and hernias, including diaphragmatic/hiatal hernias.

The proposed device is heart shaped and has a porous polytetrafluoroethylene (PTFE) side and an expanded polytetrafluoroethylene (ePTFE) side that are connected to each other on the edge with an interlocking monofilament PTFE stitch. There is also a row of stitching that is in a "V" shape which allows the device to be tailored. The prosthesis may be trimmed to the outside of the "V" stitching. The "V" stitching will continue to keep the two layers of the device together if it is tailored. An ePTFE flap is sewn to the superior edge of the patch to minimize the possibility of the device adhering to undesired structures, such as the esophagus. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.

The provided text describes the Bard CruraSoft Patch, a surgical mesh, and its 510(k) summary for regulatory clearance. It focuses on device description, intended use, and similarities/differences with predicate devices. The "Performance Data" section briefly mentions bench testing but does not provide detailed acceptance criteria or a study proving that the device meets those criteria.

Therefore, many of the requested details cannot be extracted from this document, as they are not present. This document is a regulatory submission summary, not a detailed scientific study report.

Here is what can be inferred or stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document states that performance data from bench testing "supports the safety and effectiveness" and that the device "will meet the established specifications." However, it does not list what those established specifications (acceptance criteria) are, nor does it provide specific quantitative results of the bench testing.

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

• Sample size: Not specified.
• Data provenance: Not specified (presumably internal laboratory testing, but no country of origin or retrospective/prospective nature is mentioned).

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

• Not applicable as no clinical study or human reader assessment is described.

4. Adjudication method for the test set:

• Not applicable as no clinical study or human reader assessment is described.

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 MRMC study was done. This device is a surgical patch, not an AI-assisted diagnostic tool.

6. 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/AI.

7. The type of ground truth used:

• For the bench testing mentioned, the "ground truth" would be established engineering specifications and material science standards for the physical properties and performance of the patch (e.g., tensile strength, biocompatibility, porosity, attachment integrity). The document confirms that "laboratory test results demonstrate that the materials chosen and the design utilized... will meet the established specifications."

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable.

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AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.

The AFB (Absorbable Foam Buttress) Reload is a sterile, single patient use device which consists of two components: a cartridge and an anvil carrier. A strip of buttressing material is attached to both the cartridge and anvil carrier. AFB reinforces the staple line in soft tissue while it is simultaneously being cut and stapled. AFB is prepared from a synthetic, bioabsorbable copolymer similar to that used in synthetic absorbable sutures.

The AFB is integrated into endoscopic and open linear cutting/transecting staplers and reload cartridges. The two product reload cartridge configurations are suitable for the Endopath™ Endoscopic Linear Cutter used for VATS cases and the Linear Cutter used for OPEN cases.

This document is a 510(k) summary for the AFB (Absorbable Foam Buttress) Reload device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study that evaluates device performance against such criteria.

The document primarily focuses on:

• Device Description: What the AFB Reload is and how it functions.
• Predicate Devices: Listing similar devices already on the market to establish substantial equivalence.
• Non-Clinical and Pre-Clinical Testing: General statements about testing performed (polymer composition, viscosity, thickness, tensile strength, toxicology, biocompatibility, absorbability), but no specific performance metrics or acceptance criteria are provided.
• FDA Clearance: The letter from the FDA indicating clearance based on substantial equivalence.

Therefore, I cannot provide the requested information because the provided text does not include acceptance criteria or the details of a study that proves the device meets specific performance criteria. The 510(k) clearance process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria through an explicit study reported in this summary.

To answer your request, a document detailing specific performance studies with acceptance criteria would be needed.

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