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510(k) Data Aggregation
(77 days)
The Crosseal™ Application Device is intended for the simultaneous topical application of the two biological components of Crosseal™ Fibrin Sealant via dripping (no air pressure) or via spraying (with air pressure utilizing the pressure regulator unit) onto the surface of the liver in patients undergoing liver surgery.
The Crosseal" Application Device is a sterile, single-use, disposable two-syringe device used for the application by dripping or spraying of the two biological components of Crosseal "Fibrin Sealant onto the surface of the liver in patients undergoing liver surgery. . The two syringes are connected to either a dual (nonspraying) or tri-lumen (spraying) catheter. The device also has two Mixject Dispensing Pins with Detachable Vial Holders, a device that has already been cleared by the FDA through Premarket Notification [510(k)]. The Mixject is used to attach the glass vials containing the biological components for transfer into the syringes without the use of needles. For spraying, the Application Device must be connected through an air tube with a sterile filter to a supply of pressurized gas (compressed air, nitrogen, CO2) via a pressure regulator, which is an accessory to the Application Device. For dripping, the Application Device can be used with or without pressurized gas. The device is ethylene oxide (EtO) sterilized.
The provided text describes a 510(k) premarket notification for the Crosseal™ Application Device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria in the same way a PMA or de novo submission might.
Therefore, the information available is limited and structured differently from what would typically be presented for a diagnostic AI device requiring a study proving adherence to specific acceptance criteria.
However, I can extract the relevant information based on the sections provided to best answer your request.
Acceptance Criteria and Reported Device Performance for Crosseal™ Application Device
The "acceptance criteria" for this device, in the context of a 510(k), are not explicit numerical targets for diagnostic performance (e.g., sensitivity, specificity). Instead, the studies performed aimed to demonstrate that the device functions as intended and is safe for its indicated use, specifically concerning the application of fibrin sealant. The primary performance criteria revolve around the optimal application parameters for the sealant.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Optimal Spray Application: Uniformity of mixing and consistency of spray spread. | Performance testing studies determined an optimal gas pressure range and optimal spray distance to achieve uniformity of mixing and consistency of spray spread. The optimal gas pressure was 34 psi, and the optimal spray distance was 10-15 cm. |
| Safety - Biocompatibility: No skin irritation. | A Primary Skin Irritation Evaluation found the test article extract did not produce skin irritation. |
| Safety - Biocompatibility: No sensitization. | A Guinea Pig Maximization test found the test article extract did not produce sensitization. |
| Safety - Biocompatibility: Non-cytotoxic. | A Cytotoxicity Test (MEM Elution Test) found the test article to be non-cytotoxic. |
| Safety - Biocompatibility: No acute systemic toxicity. | An Acute Systemic Toxicity Test found no reaction in mice observed over 72 hours. |
| Safety - Biocompatibility: Non-pyrogenic. | A Pyrogenicity Test (Limulus Test) found the test article to be non-pyrogenic. |
| Safety - Biocompatibility: Non-hemolytic and no effect on clotting time. | In vitro hemolysis study (modified ASTM - Direct Contact Method) and determination of clotting time (Lee-White Method) revealed the test article was non-hemolytic and did not biologically affect clotting time. |
| Clinical Efficacy: Efficacious method for optimal coverage of fibrin sealant. | Two U.S. pivotal Phase III clinical trials evaluated the optimal gas pressure (34psi) and optimal spray distance (10-15 cm). The studies demonstrated this is an efficacious method of providing optimal coverage of fibrin sealant onto the surgical tissue surface. No adverse events were associated with the system. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the sample size for the performance testing studies (e.g., how many sprays were tested or how many in vitro tests were performed). For the clinical trials, the number of patients is not specified, only that "Two U.S. pivotal Phase III clinical trials" were conducted.
- Data Provenance:
- Performance Testing: Not explicitly stated, but implies laboratory testing.
- Clinical Trials: "Two U.S. pivotal Phase III clinical trials." This indicates retrospective or prospective (likely prospective for Phase III) clinical data from the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this device submission. The "ground truth" here is objective performance (e.g., pressure, distance, biocompatibility results) and clinical outcomes (efficacy of sealant application, absence of adverse events). There is no mention of experts assessing image data or making diagnostic judgments.
4. Adjudication Method for the Test Set
Not applicable. This device is not a diagnostic device requiring adjudication of expert opinions for a test set.
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
Not applicable. This device is an application device for a sealant, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Spray Application Performance: Physical measurements of spray uniformity and consistency, potentially visual inspection, and likely quantitative analysis of sealant distribution in laboratory settings.
- For Biocompatibility: Standardized laboratory assays (e.g., primary skin irritation, guinea pig maximization, cytotoxicity, acute systemic toxicity, pyrogenicity, hemolysis, clotting time) with specific endpoint criteria.
- For Clinical Efficacy: Clinical observations within the Phase III trials, likely involving assessment of sealant coverage and related surgical outcomes, and monitoring for adverse events.
8. The Sample Size for the Training Set
Not applicable. This is not an AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this information is not relevant.
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