Search Results

The Thrombix 3X3 pad is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The Thrombix 3x3 hemostatic pad consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride in a non-woven gauze.

The provided text is a 510(k) summary for the Thrombix 3x3 hemostatic pad, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study. As such, it does not contain the detailed information typically found in an AI/medical device acceptance criteria study report.

Based on the information provided, here's what can be inferred and what is explicitly not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in this context. The document describes a comparison to predicate devices, not specific acceptance criteria for performance in the way an AI algorithm would be evaluated. The core of this submission is substantial equivalence, not a set of performance metrics.

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

• Sample Size: Not specified. The summary mentions "Tests conducted included assessment of the potlife of the pad after addition of up to 10 mls of saline." This refers to non-clinical bench testing, not a clinical test set with a defined sample size for evaluating performance in patients.
• Data Provenance: Not specified, but the testing described (potlife) would be laboratory-based (non-clinical).

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

Not applicable. There is no mention of expert-established ground truth because this is a non-clinical, non-AI device submission that relies on bench testing and comparison to predicates.

4. Adjudication Method for the Test Set

Not applicable. No expert-based adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a non-AI device.

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

Not applicable. This is a non-AI medical device.

7. The Type of Ground Truth Used

Not applicable in the typical AI sense. For the non-clinical tests mentioned ("potlife of the pad"), the "ground truth" would be the measured physical/chemical properties or the observed behavior of the pad under test conditions, evaluated against internal specifications or standard laboratory practices, rather than expert consensus, pathology, or outcomes data in a clinical setting.

8. The Sample Size for the Training Set

Not applicable. This is a non-AI device.

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

Not applicable. This is a non-AI device.

Summary of Device Information from Document:

• Device Name: Thrombix 3x3 hemostatic pad
• Description: A lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride in a non-woven gauze.
• Intended Use: Applied topically as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
• Non-Clinical Testing: Assessment of the potlife of the pad after addition of up to 10 mLs of saline.
• Predicate Devices: D-Stat Dry 3x3 hemostatic pad (K040510) and ThrombiGel thrombin/gelatin foam hemostat (K050511).
• Conclusion: The device is substantially equivalent to the predicate devices based on indications for use and technological characteristics.

Ask a specific question about this device