Search Results

Bovine Pericardium Patch 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, pneumonectomy / pneumectomy, pneumoreduction) and other incisions 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).

The Bovine Pericardium Patch is intended for use as an implant to reinforce soft tissue where weakness exists. The Boyine Pericardium Patch is derived from bovine pericardium tissue. The tissue is subjected to decontamination and decellularization processing using non-toxic reagents. The resulting mesh is intended for use as a resorbable implant for soft tissue repair which subsequently remodels and is integrated in the host connective tissue. The Bovine Pericardium Patch is terminally sterilized and is available in sizes ranging from 2cm x10cm to 8cm x16cm.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The document is a 510(k) summary for the Bovine Pericardium Patch, aiming to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" here are implicitly linked to the substantial equivalence requirements, meaning the Bovine Pericardium Patch must perform comparably to the predicate device across various aspects.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for specific performance metrics. Instead, the document demonstrates substantial equivalence by comparing the Bovine Pericardium Patch to a predicate device (Veritas® Collagen Matrix, K062915). The implicit acceptance criteria are that the Bovine Pericardium Patch's performance and characteristics are "comparable" or "substantially equivalent" to the predicate device.

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

The document does not specify a "test set" in the context of clinical trials or AI model validation. The studies described are primarily bench testing and biocompatibility testing.

• Bench/Laboratory Testing: No specific sample sizes (e.g., number of patches tested for tensile strength) are provided for each mechanical test. Data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted lab.
• Biocompatibility Testing: The specific sample sizes for animal tests (e.g., muscle implantation, subchronic systemic toxicity) are not provided. These are standard pre-clinical tests; the provenance would be from laboratory studies, likely animal models.

The data is retrospective in the sense that it's pre-market data collected to support the 510(k) submission, not an ongoing prospective clinical trial. The country of origin of the data is not explicitly stated but assumed to be from the US or a compliant lab, given the FDA submission.

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

This information is not applicable to this type of device submission. There is no mention of "ground truth" established by human experts in the context of image interpretation or diagnostic accuracy for this device, which is a surgical mesh. The "truth" for this device's performance is derived from standardized physical and biological tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. There is no expert review or adjudication process described for the bench and biocompatibility tests.

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

This information is not applicable. This is a physical medical device (surgical mesh), not an AI-powered diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

This information is not applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the bench/laboratory testing, the "ground truth" is established by standardized measurement techniques and accepted engineering principles for material properties. For biocompatibility, the "ground truth" is based on biological responses observed in validated in vitro and in vivo (animal) models, interpreted against established safety standards (e.g., ISO 10993 series). There is no "expert consensus" or "pathology" in the sense of diagnosing human conditions within this context.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

This information is not applicable for the same reason.

Ask a specific question about this device

CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use

CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.

This document describes the 510(k) submission for the CollaFirm Collagen Wound Dressing. As such, it is not a study proving device performance against acceptance criteria in the manner of an AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and shared technological characteristics and intended use.

Here's an breakdown of the information based on the provided text, addressing your questions where applicable to a non-AI/ML device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (collagen wound dressing), the "acceptance criteria" are typically the standards and tests performed to demonstrate safety, effectiveness, and substantial equivalence to existing predicate devices.

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

This document does not specify "sample sizes" in the context of a "test set" as would be relevant for an AI/ML device. The "testing" here refers to non-clinical laboratory tests performed on the device material itself. The provenance of this data is from controlled laboratory experiments, not patient data in the sense of a clinical trial or AI model evaluation.

• Sample Size for Test Set: Not applicable in the context of typical AI/ML device evaluation. The "sample" is the manufactured device material used for the specified laboratory tests (e.g., cytotoxicity, irritation, sensitization, sterility, pyrogenicity, stability). The specific number of samples tested for each assay is not detailed in this summary but would be part of the full test reports.
• Data Provenance: The tests were conducted in accordance with ISO standards and USP (United States Pharmacopeia) for sterility. This indicates the testing was performed in a laboratory setting. Country of origin for data is not explicitly stated but would typically be from accredited testing facilities. The data is non-clinical/pre-clinical.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of device submission, there is no "ground truth" in the sense of medical image interpretation or disease diagnosis established by experts. Substantial equivalence relies on comparing the device's characteristics and performance to established standards and predicate devices.

4. Adjudication Method

Not applicable. There is no adjudication method needed for establishing ground truth, as the ground truth concept (expert consensus in diagnostic tasks) does not apply here. The evaluation relies on standardized laboratory tests and comparison to predicate devices, which are objective measurements or assessments.

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. The document explicitly states: "CollaFirm Collagen Wound Dressing has not been studied in a clinical setting." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is typically for AI-assisted diagnostic or prognostic tools.

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

No, a standalone performance study (algorithm only) was not done. This is not an AI/ML device, so concepts like "algorithm only" or "human-in-the-loop" are not relevant. The device is a physical wound dressing.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this submission, "ground truth" is established through:

• Standardized laboratory tests: E.g., ISO standards for biocompatibility (cytotoxicity, irritation, sensitization), USP for sterility, LAL for pyrogenicity. The results of these tests, against predetermined pass/fail criteria, serve as empirical evidence.
• Comparison to predicate devices: The "ground truth" for substantial equivalence often involves demonstrating that the new device's properties and performance are comparable to (or within acceptable limits of) legally marketed predicate devices that have already been deemed safe and effective by the FDA. The amino acid analysis is an example of this.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI/ML device, so there is no "training set" or "ground truth for the training set."

Ask a specific question about this device