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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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The SAFE MAXI – hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.

SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAFE MAXI oxygenator is a single-use, disposable, sterile and non-pyrogenic device. The overall blood flow path is from bottom to top in the heat exchanger module and top to bottom in the gas exchange section. The inverted "U" shaped blood flow path optimizes the device's bubble trapping capabilities. Gas exchange occurs by diffusion across the porous hollow fiber membrane.

Here's an analysis of the provided text, focusing on acceptance criteria and study details. It's important to note that the provided document is a 510(k) summary for a medical device (oxygenator), which primarily demonstrates substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting a traditional clinical study with human readers assisting AI. Therefore, many of the requested categories related to AI performance, human expert involvement in ground truth, and training sets are not applicable.

Acceptance Criteria and Device Performance for SAFE MAXI Oxygenator

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "In vitro bench testing was performed according to the FDA's 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff' of November 13, 2000. Reference to the ISO 7199:1996 standard was made where appropriate." This implies that the acceptance criteria for each test were derived from these detailed guidelines and standards, but the specific numerical criteria are not explicitly stated in this high-level summary.

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

The document does not explicitly state the specific sample sizes for each in-vitro or in-vivo test. It only mentions that "in-vitro testing was performed" and "animal testing was performed."

• Test Set Sample Size: Not explicitly stated in the document for individual tests.
• Data Provenance:
  • In-vitro Bench Testing: Performed in accordance with FDA guidance and ISO 7199:1996. The location of the testing facility or specific details are not provided, but it's presumed to be the manufacturer's or a contracted lab. This would be prospective testing for the SAFE MAXI device.
  • Biocompatibility Testing: Similar to in-vitro bench testing, performed according to recognized standards.
  • In-vivo Testing: Animal testing was performed. The type of animal, number of animals, and location are not specified. This would be prospective testing on the SAFE MAXI device.

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

This information is not applicable to this type of device submission. This submission does not involve an AI algorithm with a "ground truth" established by human experts in the way suggested by the question. The "ground truth" for the oxygenator's performance is objective measurement against engineering and biological standards, or comparison to a predicate device.

4. Adjudication Method for the Test Set

This is not applicable. There's no "adjudication method" in the context of human expert review for establishing ground truth, as there's no diagnostic output or interpretation involved that would require such a process. The results of the physical, performance, and biological tests are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The submission is for a medical device (oxygenator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study to measure improvement with AI vs. without AI assistance was not performed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance)

This is not applicable. The device is an oxygenator, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here. The device's performance is inherently its "standalone" performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance and safety is established through:

• Objective Measurements: Results of physical tests (e.g., integrity, flow rates, volume capacity), performance tests (e.g., gas transfer rates, pressure drops, heat exchange efficiency), and biocompatibility assays (e.g., cytotoxicity, hemolysis).
• Adherence to Standards and Guidance: Compliance with FDA's "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions" and ISO 7199:1996 standards.
• Comparative Performance to Predicate Device: Demonstration of substantial equivalence to the legally marketed Quadrox HMO 1010 HF Membrane Oxygenator. This means the SAFE MAXI's performance fell within an acceptable range relative to the predicate, as defined by the aforementioned standards and guidance.
• In-vivo (Animal) Data: Safety and function demonstrated in an animal model.

8. Sample Size for the Training Set

This is not applicable. The SAFE MAXI oxygenator is a physical medical device, not an AI algorithm that undergoes "training" on a dataset.

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

This is not applicable for the same reasons as #8.

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The SAFE MAXI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

SAFE MAXI venous/cardiotomy reservoir is a hard shell reservoir with separate venous and cardiotomy inlets. The venous inlet with 175 micron venous filter is placed at the bottom of the reservoir, which provides a bottom to top venous blood flow. Returning suction blood enters the large surface area 20 micron depth filter at the top of the reservoir. The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.

This 510(k) summary describes a medical device, the SAFE MAXI venous/cardiotomy reservoir, and its claim of substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving the device meets them through a dedicated study with defined metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted directly from this document.

However, based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating similar characteristics and comparable performance to predicate devices to establish substantial equivalence.

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

The document does not specify a distinct "test set" in the context of a clinical or performance study with a defined sample size. The evaluation appears to be based on:

• Biocompatibility: Likely laboratory testing, potentially on material samples or the predicate device.
• Blood Cell Damage Test: This was performed using a "same blood pool" setup, suggesting a comparative in vitro or ex vivo experiment. The number of samples or runs is not specified.
• Effectiveness Testing: "Evaluating its operational characteristics" suggests various engineering or bench tests.

Data Provenance: Not explicitly stated, but given the manufacturer (POLYSTAN A/S, Denmark), the testing would likely have taken place in a laboratory setting, possibly in Denmark or the US. The nature of these tests (e.g., in vitro, bench testing) means they are not "retrospective" or "prospective" in the clinical trial sense.

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

Not applicable. This type of device evaluation (substantial equivalence to predicates for a physical component) does not involve expert consensus on "ground truth" derived from clinical cases, as would be common for diagnostic algorithms or imaging devices.

4. Adjudication Method for the Test Set

Not applicable. As above, this isn't a study design that involves expert adjudication of findings.

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 a passive medical component (blood reservoir) and does not involve AI or human "readers."

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

Not applicable. This device is a physical component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices. The device's substantial equivalence is established by demonstrating (through laboratory/bench testing) that its performance and safety characteristics are comparable.

• Biocompatibility: Chemical and biological testing standards (e.g., ISO 10993).
• Blood Cell Damage: Measured parameters (e.g., free hemoglobin, platelet activation) in an in vitro setup.
• Effectiveness: Engineering performance metrics (e.g., flow rates, defoaming efficiency, filtration efficacy, volume capacity).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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The SAFE MINI hollow fibre oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.

The SAFE MINI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Polystan AS for their SAFE MINI Membrane Oxygenator with Integrated Heat Exchanger. It states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.

The letter explicitly states the Indications For Use for the device:

• SAFE MINI hollow fibre oxygenator: intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
• SAFE MINI venous/cardiotomy reservoir: intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

To answer the request, information from a separate study report or regulatory submission, which is not part of this document, would be required.

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