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(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA018S, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place.

(Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate.

(Models FEMII010A, FEMII014A, FEMII014A, FEMII008AT, FEMII010AT, FEMII012AT, FEMII014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass.

Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.

The ERMI Pediatric Arterial Cannulae are used to access the aorta or femoral artery during cardiopulmonary bypass.

Here's an analysis of the provided 510(k) summary, specifically addressing the requested information about acceptance criteria and the study that proves the device meets those criteria:

Device: Edwards Lifesciences Research Medical Inc. Pediatric Arterial Cannulae

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not provide details on the sample size used for functional or biocompatibility testing, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states the tests were "successfully undergone."

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

This information is not provided in the 510(k) summary. The summary focuses on engineering and biocompatibility testing, which generally do not involve clinical experts in establishing ground truth in the same way as, for example, diagnostic imaging devices.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary. Given the nature of functional and biocompatibility testing, a traditional adjudication method for establishing ground truth from multiple expert readings is typically not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or is relevant for this medical device. This device is a physical medical instrument (cannula) used during cardiopulmonary bypass, not an AI or diagnostic imaging tool. Therefore, there is no human-in-the-loop AI assistance aspect to evaluate.

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

No standalone algorithm performance study was done or is relevant for this medical device. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The ground truth used for this device would be based on engineering specifications and established regulatory standards for functional performance and biocompatibility of medical devices.

• Functional Testing: Ground truth would be defined by the pre-established performance specifications (e.g., flow rates, resistance, integrity under pressure, connection security).
• Biocompatibility Testing: Ground truth would be defined by the biological response observed in accordance with ISO 10993 standards and relevant regulatory guidelines.

8. The sample size for the training set

This information is not provided and not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are validated through engineering principles and quality systems, not machine learning training.

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

This information is not provided and not applicable. As explained above, there is no training set for this type of device. The "ground truth" for its design and manufacturing is established through adherence to quality management systems (e.g., ISO 13485, 21 CFR Part 820) and compliance with industry standards for materials and performance.

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These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.

The One Piece Pediatric Arterial Cannula Models 77006 and 77106 are 6 Fr., flexible, thin-walled cannula with wire wound bodies and a 9" overall length. They have a beveled tip that is made as part of the PVC body. There are depth markings located at 1 cm increments. A tip orientation line indicates the direction of the bevel for location once the cannula is inside the body. The proximal end of the cannula terminates in a 1/4" barbed connector that can be either vented or non-vented. The model 77006 is vented and the model 77106 is non-vented. The proximal end connector on these models is also molded as part of the body.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Medtronic Perfusion Systems "One Piece Pediatric Arterial Cannula Models 77006 and 77106":

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The text only mentions "various bend tests" and general "in vitro visual, dimensional, simulated use and functional testing."
   • Data Provenance: The "Summary of Performance Data" describes "in vitro" testing. This implies the data was generated in a lab setting, likely without direct human patient involvement or geographical origin listed. It does not indicate retrospective or prospective data from a clinical setting.

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

   • Not applicable. The study involved in vitro testing of the device's physical and functional properties, not a diagnostic or AI-based assessment requiring expert ground truth establishment.

3. Adjudication method for the test set:

   • Not applicable. As noted above, this was an in vitro engineering performance study, not a clinical study or AI performance evaluation requiring adjudication of interpretations. The "acceptance" was likely based on pre-defined engineering specifications and test protocols.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical cannulae, not an AI-powered diagnostic tool requiring human reader comparisons.

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

   • Not applicable. This device is a physical medical product, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for this study was established by engineering specifications, design requirements, and pre-defined test protocols for the physical and functional characteristics of the cannulae. The "accepted" results indicate that the device met these engineering specifications.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical product, not an AI model requiring a training set.

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

   • Not applicable. As above, there was no AI model or training set.

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The Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.

The Polystan pediatric arterial cannula is single-use, disposable, sterile and non-pyrogenic device. The cannula has a tapered wire reinforced PVC body with an open beveled distal tip. Three depth indicator marks are positioned at approximately 2 cm intervals from the distal tip. A stylet is incorporated to assist cannulation. The proximal cannula end terminates with either a " /16" or ¼" capped connector incorporating a female luer fitting. The cannulae range in size from 6 Fr. to12 Fr.

This K023251 submission is for a medical device (Pediatric Arterial Cannula), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies are not applicable.

However, I can provide information based on the device's summary of safety and effectiveness as a medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided summary. The summary mentions "testing," but details on the number of units tested for each performance criterion are not provided.
• Data Provenance: Not explicitly stated. Given that it's a submission from a Danish company (POLYSTAN A/S), the testing would likely have been conducted in their facilities or contracted labs, adhering to international standards.

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

This is not applicable to a medical device like a cannula. "Ground truth" in this context typically refers to an expert-validated diagnosis or finding, which is relevant for diagnostic AI algorithms. For a physical device, performance is measured against established scientific and engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective interpretations of data, often in the context of diagnostic assessments. Device performance testing relies on objective measurements and comparison to predefined acceptance criteria.

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. MRMC studies are for evaluating diagnostic accuracy, particularly for image-based diagnostics with human readers, and the impact of AI assistance on those readers. This device is a physical cannula, not an AI diagnostic tool.

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

Not applicable. This question pertains to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the AI/ML sense. For this device, the "ground truth" (or basis for evaluation) is established by:

• Adherence to recognized biocompatibility standards (USP 23, USP 24, ISO 10993).
• Comparative performance data against a legally marketed predicate device (Jostra Pediatric Arterial Cannula - K012617), implying that the predicate's established safety and performance serve as the benchmark.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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