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510(k) Data Aggregation
(169 days)
Chalice Medical Ltd
The CMO8 Adult PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The CMO8 Adult PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal crculation during cardiopulmonary bypass procedures, lasting 6 hours or less.
The CMO8 Adult PMP oxygenator (CMO8) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The CMO8 facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The CMO8 is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The qas exchanger part of the CMO8 is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the CMO8 is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated. The Tubing Pack, which contains blood lines, gas lines, a venous reservoir and the CMO8 Oxygenator, is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
The provided text is a 510(k) summary for a medical device (CMO8 Adult PMP Oxygenator with Tubing Pack) and not a report or study describing the acceptance criteria or performance of an AI/ML powered device.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them from this document. The document primarily discusses the substantial equivalence of a physical medical device (an oxygenator) to predicate devices through in vitro and non-clinical testing.
The questions you asked are highly relevant to AI/ML device submissions, particularly regarding:
- Acceptance Criteria and Performance Table: This is typically a key component of AI/ML device validation.
- Sample Size and Data Provenance: Crucial for understanding the representativeness and generalizability of AI/ML model testing.
- Expert Ground Truth (Number of Experts, Qualifications, Adjudication): Essential for establishing reliable labels for AI/ML training and testing data.
- MRMC Studies: Often used to evaluate the impact of AI on human reader performance.
- Standalone Performance: Evaluating the AI algorithm's capabilities independently.
- Type of Ground Truth: The gold standard used to assess AI accuracy.
- Training Set Details: Information about the data used to develop the AI model.
To answer your request, I would need a document detailing the clinical validation or performance study for an AI/ML-powered medical device.
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(93 days)
Chalice Medical Ltd
The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.
The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
The document provided is a 510(k) summary for a medical device (Paragon Adult Maxi PMP Oxygenator with Tubing Pack) and does not contain information about an AI/ML powered device or study that determines acceptance criteria based on AI/ML performance.
The provided text details the regulatory review of a conventional medical device (oxygenator and tubing pack) and focuses on its substantial equivalence to predicate devices, in vitro and non-clinical test results. There is no mention of acceptance criteria related to a study proving an AI/ML device meets them. Therefore, I cannot extract the requested information from the provided document.
Ask a specific question about this device
(295 days)
Chalice Medical Ltd
The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours.
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
The provided text describes information for a K191246 submission regarding a Cardiopulmonary Bypass Oxygenator, not an AI/ML medical device. Therefore, it does not contain the specific details requested for an AI/ML device, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), nor does it describe studies involving human readers, training/test sets, or ground truth established by experts.
The document focuses on the Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP), a physical medical device. The "acceptance criteria" and "study that proves the device meets acceptance criteria" are discussed in terms of the device's physical and functional performance, rather than AI model performance.
However, I can extract and present the physical device's performance evaluation in a table format as requested, interpreting "acceptance criteria" in the context of this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Performance Characteristic Evaluated) | Method | Acceptance Criteria (Implied by Conclusion) | Reported Device Performance |
|---|---|---|---|
| Blood Pathway Integrity | Non-comparative | Device must meet integrity standards. | Acceptance criteria met by the devices. |
| Heat Exchanger Fluid Pathway Integrity | Non-comparative | Device must meet integrity standards. | Acceptance criteria met by the devices. |
| Gas Pathway Integrity | Non-comparative | Device must meet integrity standards. | Acceptance criteria met by the devices. |
| Connector Security | Non-comparative | Device must meet security standards. | Acceptance criteria met by the devices. |
| Coating Characterization | Non-comparative | Device must meet coating characterization standards (referring to Rheopak surface coating). | Acceptance criteria met by the devices. |
| Oxygen Transfer Rates | Comparative | No statistically significant difference compared to the predicate device. | No statistically significant difference in the O2 transfer rates of the Paragon Maxi oxygenator and the predicate. |
| Carbon Dioxide Transfer Rates | Comparative | No statistically significant difference compared to the predicate device. | No statistically significant difference in the CO2 transfer rates of the Paragon Maxi oxygenator and the predicate. |
| Blood Side Pressure Drop | Comparative | Acceptable blood side pressure drop, potentially lower than predicate due to design differences. | The Paragon Maxi has a lower blood side pressure drop than the predicate oxygenator as a consequence of slight differences in the oxygenator design. |
| Heat Exchanger Performance Factor | Comparative | No statistically significant difference compared to the predicate device. | No statistically significant difference in the heat exchanger performance of the Paragon Maxi oxygenator and the predicate. |
| Blood Cell Damage | Comparative | No statistically significant difference in markers like hemolysis, white blood cell count, platelet count compared to the predicate device. | No statistically significant difference in the blood cell damage test results (e.g. hemolysis, white blood cell count, platelet count) of the Paragon Maxi oxygenator and the predicate. |
| Biocompatibility | Non-comparative | Biocompatible and biologically safe according to ISO 10993-1:2009. | Biocompatibility and biological safety demonstrated. |
| Sterility (SAL) | Non-comparative | Sterility Assurance Level (SAL) of 10^-6. | Achieved a SAL of 10^-6 by ethylene oxide gas sterilization. |
| Pyrogen Levels | Non-comparative | Endotoxin levels below the 'Endotoxin Release Limit' of |
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