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The Jostra Pediatric Arterial Perfusion Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.

The Jostra Pediatric Arterial Perfusion Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.

This document is a 510(k) summary for a medical device modification, specifically the Jostra Pediatric Arterial Cannulae. It discusses the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study data.

Here's an analysis of what can be extracted and what is missing, based on the provided text:

Key Takeaway: This 510(k) is for a modification to an already cleared device. The primary change is a material change for the white depth markings. The risk analysis and testing focuses on the impact of this specific modification, not a comprehensive de novo validation of the entire device.

Information Extracted from the Document:

Given the nature of this 510(k) for a modification, the acceptance criteria and supporting studies are limited to addressing the impact of the material change.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria / Hazard Addressed	Reported Device Performance / Assessment
   General Hazards related to biocompatibility	Evaluated (implicitly by showing no risk potential, likely through existing biocompatibility data for the new material or component)
   Hazards related to manufacturing: adhesiveness of the position marker	Tested (implicitly by showing no risk potential, confirming the new material / manufacturing process maintains sufficient adhesiveness)
   Overall Safety and Effectiveness	"The evaluation and test results do not show any kind of risk potential for the user and/or the patient. Based on the test results and evaluation the Pediatric Arterial Perfusion Cannulae are safe and effective for its intended use..."
   Substantial Equivalence	"are substantially equivalent to the named predicate device. The modification does not alter the fundamental scientific technologies..."

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/prospective). It's implied the testing was conducted by Maquet Cardiopulmonary AG in Germany.

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

   • Not applicable to this type of device modification study. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices or those requiring subjective assessment. The evaluation here is for material and manufacturing properties.

4. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of diagnostic outcomes.

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 is not an AI-enabled diagnostic device.

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

   • Not applicable. This is not an AI-enabled device.

7. The type of ground truth used:

   • For biocompatibility: Likely laboratory testing results against established standards (e.g., ISO 10993).
   • For adhesiveness of the position marker: Likely mechanical integrity testing results (e.g., tensile strength, peel strength) against internal specifications or performance of the predicate device's markings.
   • The "ground truth" here is the pass/fail result of these engineering and safety tests.

8. The sample size for the training set:

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

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

   • Not applicable.

Summary of Missing Information and Why:

The provided document is a 510(k) summary for a minor modification to an existing device (material change for markings). Such submissions are typically brief and focus on demonstrating that the change does not adversely affect safety or effectiveness, thus maintaining "substantial equivalence" to the predicate device.

Therefore, the document does not contain:

• Specific quantitative acceptance criteria with numerical targets.
• Detailed test protocols or raw data.
• Explicit sample sizes for specific tests.
• Information related to human readers, AI, or "ground truth" in the medical image analysis sense, as the device is a physical medical instrument (pediatric arterial cannulae).
• Information on training sets, as it's not an AI/ML device.

The "study" referenced is a "risk analysis method used... acc. to the logic of a Failure Modes and Effects Analysis (FMEA)" and subsequent "design verification tests." The results of these unspecified tests are summarily reported as showing "no kind of risk potential" and confirming safety and effectiveness.

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