The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.

KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours.

The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308).

The provided text is a 510(k) premarket notification for a medical device called "KIDS Arterial Filters." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, expert review processes, or any form of AI/ML performance study.

The document explicitly states:

• "No clinical testing was conducted in support of the KIDS Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use." (Page 7, Section VIII. Clinical Performance Data)
• The performance data is described as "Non-Clinical Performance Data" and states: "Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the KIDS Arterial Filters... The KIDS Arterial Filters comply with all the applicable voluntary standards related to Arterial Filters. The devices passed all the testing in accordance with national and international standards." (Page 7, Section VII. Non-Clinical Performance Data)

Therefore, based on the provided text, I cannot answer the questions related to the acceptance criteria and the study proving the device meets these criteria in the context of AI/ML device performance or clinical study results.

The device is a physical medical device (an arterial filter), not an AI/ML software device, and its approval is based on substantial equivalence to existing devices through non-clinical testing and adherence to standards, not through clinical performance metrics or AI algorithm validation.

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The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.

MICRO Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bvpass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and thev can be used up to 6 hours.

The MICRO Arterial Filters are the modified version of the following currently marketed devices:

a) the D734 Micro 40 included in the Dideco Micro 20 & 40 Adult Arterial Filter (K952270) and in the Dideco MICRO 40 Ph.I.S.I.O. Adult Arterial Filter (K040184); b) the D736 Micro 40 included into the Dideco Newborn/Infant Arterial Filters, 20/40 Micron (K961869) and in the D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for D736 MICRO 40, DIdeco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen (K033987);

c) the D733 Micro 40 included in the D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (K041061) and in the D731 MICRO 27 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Arterial Filters (K112525).

This document is a 510(k) summary for the MICRO Arterial Filters, detailing their substantial equivalence to previously cleared predicate devices. It focuses on the device's technical characteristics and non-clinical performance data, rather than providing specific acceptance criteria and study results in the context of an AI/human reader performance study.

Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, MRMC studies, and training set details for an AI-powered device cannot be extracted from this document because it describes a hardware medical device (a filter), not an AI/software as a medical device (SaMD).

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Information that CAN be extracted:

• Device Name: MICRO Arterial Filters
• Regulation Number/Name: 21 CFR 870.4260, Cardiopulmonary Bypass Arterial Line Blood Filter
• Regulatory Class: Class II
• Product Code: DTM
• Applicant: SORIN GROUP ITALIA S.R.L.
• Indications for Use: "The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised."
• Device Description: Single-use, non-toxic, non-pyrogenic fluid path devices, sterile and individually packaged, made of plastic (mainly PVC) and a silicon filtering net. Used for up to 6 hours. Modified versions of existing devices, with changes to tubing material (removal of DEHP) and silicon formulation of the valve's diaphragm. Ethylene oxide sterilized.
• Predicate Devices: Multiple predicate devices listed by 510(k) number and trade name (e.g., K952270 DIDECO ADULT ARTERIAL FILTERS).
• Type of Study (General): Non-clinical performance data (verification and validation testing) was conducted to demonstrate substantial equivalence.
• Clinical Performance Data: "No clinical testing was conducted in support of the MICRO Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."
• Ground Truth Type (for this device's testing): Implied to be based on adherence to applicable voluntary standards and "proven safety and efficacy" of predicate devices through non-clinical testing.

Information that CANNOT be extracted (as this is not an AI/SaMD submission):

• A table of acceptance criteria and the reported device performance (in the context of AI metrics like sensitivity, specificity, AUC): Not applicable for this hardware device. Acceptance criteria would relate to physical performance (e.g., filtration efficiency, pressure drop, biocompatibility), which are not explicitly detailed here beyond a general statement of compliance.
• Sample sizes used for the test set and the data provenance: Not applicable. Testing was likely bench testing, not a clinical study on human data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a filter device is based on engineering specifications and material science, not expert image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While "ground truth" exists for the filter's performance, it's not in the AI/clinical interpretation sense. It's about meeting engineering and biocompatibility standards.
• The sample size for the training set: Not applicable (no AI model).
• How the ground truth for the training set was established: Not applicable (no AI model).

To summarize, this document describes the FDA clearance of a medical device (an arterial filter) based on "substantial equivalence" to existing hardware devices, primarily through non-clinical performance testing (bench-top testing, material compatibility, etc.). It does not involve any AI/machine learning components or associated studies on human or expert annotated data.

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Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text discusses the Affinity Fusion Oxygenator and its acceptance criteria, specifically focusing on the addition of an alternate hollow fiber supplier.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Biocompatibility Testing:

*Note on "Pressure Integrity": Devices conditioned only to factors significant for leaks (per Two Proportion statistical test).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample sizes for the test sets (number of oxygenator units tested) for design verification or biocompatibility. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The nature of the tests (engineering performance and biocompatibility) suggests these were primarily laboratory-based prospective tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the type of device and testing described. The "ground truth" for a medical device like an oxygenator is established through objective performance measurements and standardized biocompatibility tests, not subjective expert assessment as would be the case for image interpretation or diagnosis.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. The tests described here are objective performance and safety tests.

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:

This is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is an oxygenator, not an algorithm.

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

The ground truth for this device is based on:

• Engineering specifications and standards: For performance characteristics like O2 Transfer, CO2 Transfer, Pressure Drop, Burst, Filtration Efficiency, etc. "PASS" implies meeting predefined, objective measurable criteria.
• International standards for biocompatibility (ISO 10993-1:2018): For tests like cytotoxicity, sensitization, genotoxicity, hemocompatibility, etc. "PASS" means meeting the established safety thresholds for these biological endpoints.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set. The "study" described is a series of laboratory-based design verification and biocompatibility tests.

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

This is not applicable, as there is no training set for this type of device.

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The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.

The OCS™ Heart Leukocyte Depleting Filter is a sterile, single-use filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system. The polycarbonate housing is 3.2" high and 3.0" in diameter. It has 1/4" fittings and includes a hydrophobic gas-permeable membrane and vent port to allow air to efficiently vent during priming and use. The leukocyte depleting material is a melt blown polyester media supplied by Pall Biomedical (the same material as is used in the predicate device). It has 6 layers, approximately 5 pleats per inch. It includes a polypropylene extruded diamond mesh that provides support for the polyester filter media. The priming volume is 273.5 mL and the anticipated flow rate (associated with gravity feed from a blood collection bag) is 1.9 L/min. During use, the blood enters through the inlet port, flows through the filter media to the interior of the filter element, and then exits through the outlet port. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

This document describes the TransMedics, Inc. OCS™ Heart Leukocyte Depleting Filter, for which a 510(k) premarket notification (K231362) was submitted. The device is a sterile, single-use filter intended to reduce leukocytes from donor blood before it is introduced into the OCS™ Heart System for heart preservation. The submission claims substantial equivalence to the legally marketed predicate device, LeukoGuard BC2 (K902518) by Pall Biomedical.

The document does not contain a table of acceptance criteria or specific reported device performance values for the OCS™ Heart Leukocyte Depleting Filter, nor does it detail a study that explicitly proves the device meets these criteria with quantitative results. Instead, it broadly states that "Bench testing has demonstrated acceptable performance of the device, that it meets all acceptance criteria and that the OCS Heart Leukocyte Depleting Filter is acceptable for clinical use."

However, based on the provided information, we can infer some aspects related to its performance and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, a direct table is not present. However, the document lists areas of testing that imply acceptance criteria would be related to:

• Leukocyte and platelet depletion: The device is expected to effectively deplete leukocytes (and platelets). It's stated that the proposed device removes more leukocytes and platelets due to its larger size, implying higher effectiveness in this aspect. For the predicate, the acceptance criteria would be established historical performance data.
• Filtration time: The device must filter blood within an acceptable timeframe.
• Hold-up volume, priming volume, and pressure drop: These physical characteristics must be within specifications.
• Maximum flow rate: The device must be compatible with the OCS Heart system's flow requirements (antecedently, 1.9 L/min).
• Structural integrity: The filter must maintain its structural integrity during use.
• Hemolysis: The device should not cause excessive hemolysis.
• Biocompatibility: Meet ISO 10993-1 standards (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity, USP Physicochemical Test for plastics).
• Sterility: Achieve a sterility assurance level (SAL) of 10^-6.
• Shelf life: Maintain integrity and performance for 12 months.

Reported Device Performance:
The document states that "The testing demonstrated that the OCS Heart Leukocyte Depleting filter met all specifications and was shown to be equivalent to the predicate device."
Specifically, regarding leukocyte and platelet depletion, it mentions: "The OCS Heart Leukocyte Depleting Filter is larger (273.5 mL priming volume compared to 95 mL priming volume for the LeukoGuard BC2) and therefore removes more leukocytes and platelets than the predicate device." It further clarifies, "an increased level of leukocyte depletion does not raise a different question of safety or effectiveness."

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

• Test Set Sample Size: Not explicitly stated. The testing includes "Bench performance testing" and "Pre-Clinical Validation using the OCS Heart Leukocyte Depleting Filter with the OCS Heart System to preserve swine hearts." The number of "swine hearts" or other samples used for bench testing is not provided.
• Data Provenance: The biocompatibility studies were conducted by NAMSA (Norwood, OH) and Ethide Laboratories (West Warwick, RI), both in the USA. The "Pre-Clinical Validation" using swine hearts suggests an animal model, likely conducted in a controlled laboratory setting. The data is retrospective in the sense that the testing was performed to support the 510(k) submission, not as a continuous monitoring effort.

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

• General Assessment: This information is not applicable in the context of device performance testing for a medical filter. The "ground truth" for the performance tests (e.g., leukocyte count, flow rate, hemolysis level) would be established by scientific measurement techniques and validated laboratory standards, not by expert consensus in the typical sense of diagnostic accuracy studies.
• Biocompatibility Testing: Conducted in compliance with 21 CFR Part 58 (GLPs) and according to ISO-10993-1 and USP standards. Experts involved would be qualified laboratory personnel in toxicology, microbiology, and materials science.

4. Adjudication Method for the Test Set:

• Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., imaging studies) where discrepancies among readers need to be resolved. Performance testing of a filter involves objective measurements against predefined specifications.

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

• No. An MRMC study is not relevant for this device. This type of study assesses diagnostic accuracy and inter-reader variability, usually in imaging or pathology. The OCS Heart Leukocyte Depleting Filter is a physical device with measurable performance characteristics.

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

• Yes, in a sense. The bench testing and pre-clinical validation (swine hearts) represent "standalone" performance evaluations as they assess the device's function directly without human interaction being the primary variable. The device itself does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

• Objective Measurements/Scientific Standards: The "ground truth" for the device's performance is based on objective measurements against established scientific and engineering standards.
  • Leukocyte/Platelet Depletion: Laboratory assays to quantify cell counts before and after filtration.
  • Filtration Time, Flow Rate, Volumes, Pressure Drop: Engineering measurements.
  • Structural Integrity: Physical stress tests and observation.
  • Hemolysis: Laboratory assays to measure hemoglobin release.
  • Biocompatibility: Results from validated in vitro and in vivo toxicological tests (e.g., cytotoxicity, sensitization tests according to ISO 10993-1).
  • Sterility: Microbiological validation tests to confirm SAL.
  • Pre-Clinical Validation (Swine Hearts): Likely physiological measurements of heart function and integrity after blood processing by the device in an isolated organ system.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical filter, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design, materials, and manufacturing process are based on established engineering principles and the performance of the predicate device.

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

• Not applicable, as there is no training set for this type of device.

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The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text is a 510(k) Summary for the Medtronic Affinity Fusion Oxygenator System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not explicitly provided in this type of regulatory submission.

However, I can extract the relevant information that is available and clarify what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an "AI system" or "medical device performance" in the general sense, as typically sought in such a request. Instead, it refers to "predetermined requirements" and "improved bond performance" for specific components.

The "performance" referred to in this document primarily relates to the device meeting its intended function as an oxygenator and arterial filter during cardiopulmonary bypass. The summary states that "Operation and performance qualification... were completed" and that "the manufacturing process consistently produces product that meets predetermined requirements."

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

The document does not specify a "test set" in the context of an AI/algorithm evaluation. For the physical device modifications, it mentions "random sampling and statistical modeling" for the TMA seal, but no specific sample sizes or data provenance (country, retrospective/prospective) are provided for these manufacturing/design evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document. The submission pertains to modifications of a physical medical device (oxygenator) and its manufacturing process, not to an AI/algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method

This information is not applicable to the provided document, as it does not describe an AI/algorithm evaluation requiring adjudication of ground truth.

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

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve AI assistance to human readers.

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

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve an AI algorithm.

7. Type of Ground Truth Used

This information is not applicable in the context of an AI/algorithm. For the physical device, the "ground truth" or verification is based on engineering specifications, performance testing (pressure integrity, burst, torque, insertion depth), and biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

This information is not applicable to the provided document, as it does not describe an AI/algorithm that would require a training set.

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

This information is not applicable to the provided document, as it does not describe an AI/algorithm.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator System, which involves modifications to a legally marketed predicate device (K203111). The core of the submission is to demonstrate substantial equivalence to this predicate device.

The study presented is not a classic "clinical trial" or "AI validation study" but rather a series of engineering and qualification tests to ensure that the modifications (specifically, changes to the Temperature Monitoring Adapter (TMA) insert component material and insertion depth, and different bioactive surfaces) do not alter the fundamental performance, safety, or efficacy of the device.

Key points from the document regarding "proof" and "acceptance":

• Proof of Meeting Acceptance Criteria: The proof is based on "Operation and performance qualification (OQ/PQ)" and "Design Characterization" activities. These activities evaluate various physical properties and manufacturing consistency.
• Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance (e.g., pressure integrity, burst, torque, insertion depth, biocompatibility) meets internal predetermined requirements and does not introduce new hazards compared to the predicate device. For example, the TMA bond evaluation "indicated improved bond performance relative to the current material," suggesting a performance target was met or exceeded. Biocompatibility was accepted based on the new material already being used in another cleared device and conforming to ISO 10993.
• Study Design: The study is a non-clinical engineering and bench testing evaluation rather than a clinical trial or AI performance study. It's focused on validating the impact of specific component changes.
• Conclusion: The manufacturer concluded, and the FDA agreed by clearing the device, that these modifications maintain substantial equivalence to the predicate device, meaning it is as safe and effective as a device already on the market.

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INSPIRE 6F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F M is intended to be used for 6 hours or less.

INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less.

INSPIRE 8F M is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less.

The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8M is intended to be used for 6 hours or less.

The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE model 6F M also has an integrated arterial filter. The INSPIRE 6F M device can be operated at flow rates up to 6 liters per minute (I/min). The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli. The device is a modified version of the currently marketed INSPIRE 6F M products.

The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE 6M device can be operated at flow rates up to 6 liters per minute (I/min). The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The device is a modified version of the currently marketed INSPIRE 6M products.

The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE model 8F M also has an integrated arterial filter. The INSPIRE 8F M device can be operated at flow rates up to 8 liters per minute (I/min). The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli. The device is a modified version of the currently marketed INSPIRE 8F M products.

The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE 8M device can be operated at flow rates up to 8 liters per minute (I/min). The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The device is a modified version of the currently marketed INSPIRE 8M products.

The provided document is a 510(k) premarket notification for several models of the INSPIRE Hollow Fiber Oxygenator. This type of submission is for demonstrating substantial equivalence to a predicate device, not necessarily for proving novel clinical effectiveness or "AI" performance.

Based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance

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

The document mentions "Testing was performed to compare devices with the modified and predicate gas outlet port." It states this was "in vitro test results" and conducted on "sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling."

• Sample size for the test set: Not explicitly stated. The document refers to "devices" in the plural, but the exact number is not provided.
• Data provenance: In vitro testing, which means it's laboratory-based data, not human patient data. It is prospective testing designed to evaluate the modified device. The country of origin for the data is not specified, but the submitter is Sorin Group Italia S.r.l. in Mirandola (MO) ITALY.

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

Not applicable. This was in vitro performance testing of a medical device, not a human reader study requiring expert opinion for ground truth.

4. Adjudication method for the test set

Not applicable. This was in vitro performance testing of a medical device against predefined engineering/performance criteria, not a study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This document describes in vitro testing of a device's physical and functional properties, not a reader study. There is no mention of human readers or AI assistance.

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

No. This is not an AI/algorithm-based device. It's a cardiopulmonary bypass oxygenator. The testing described is for the device itself.

7. The type of ground truth used

The "ground truth" for this in vitro performance testing would be the predefined engineering specifications and performance standards for moisture handling for oxygenator devices. The document states "successfully met all acceptance criteria for moisture handling," implying these criteria were established prior to the testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and requlates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 5 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The membrane oxygenator QUADROX-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The QUADROX-i Small Adult / Adult and QUADROX-iD Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter (only available for QUADROX-I Small Adult / Adult). They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. The integrated arterial filter is intended to filter out air bubbles and particles larger than 40µm. It is used for removing gaseous embolisms and aggregates from blood components from the arterial blood during extracorporeal circulation. It is a screen filter with pre-post-de-airing mechanic.

The provided text is a 510(k) summary for medical devices, specifically cardiopulmonary bypass oxygenators. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies or acceptance criteria for independent device performance. Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment are not present in this submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in the sense of predefined thresholds for performance metrics. Instead, it describes "performance testing" that demonstrated the modified devices perform "within its specifications and within the acceptable limits of the applied performance standards." The specific performance characteristics tested are listed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the "performance testing." It also does not explicitly state the data provenance (country of origin or retrospective/prospective nature). The submitter, MAQUET Cardiopulmonary AG, is based in Germany, and the contact person is in the USA, so the testing could have occurred in either or both regions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of testing described. The "ground truth" for mechanical and biological performance of an oxygenator is typically established through standardized laboratory tests and engineering benchmarks, not expert consensus on medical images or clinical outcomes.

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

This is not applicable. Adjudication methods like those described are typically used in clinical studies involving human interpretation or subjective assessments, which are not detailed here.

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

This is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool. No MRMC study involving human readers or AI assistance was conducted or mentioned.

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

This is not applicable. The device is a physical medical device (oxygenator), not a software algorithm.

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

The "ground truth" for the non-clinical tests listed would be established by the physical and chemical properties measured during laboratory testing against defined standards. For example, "Blood Cell Damage" would likely be measured by hemolysis rates, "Stability" by structural integrity under stress, and "Integrity" by leak tests, all compared to pre-defined specifications derived from engineering standards and regulatory requirements.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device and its non-clinical performance testing, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. The AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The provided text is a 510(k) Summary for a medical device (Affinity® AF100 Arterial Filter with Carmeda® BioActive Surface) seeking a determination of substantial equivalence to a predicate device. This type of regulatory submission in the U.S. FDA context focuses on comparing a new device to an already legally marketed one, rather than presenting a detailed study proving the new device's independent efficacy against acceptance criteria in the way clinical trials for novel devices do.

Therefore, many of the requested elements pertaining to a clinical study (like sample size for test sets and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of document because it describes pre-clinical bench testing for substantial equivalence, not a clinical effectiveness study.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "performance tests" that were conducted to demonstrate substantial equivalence to the predicate device. However, it does not specify quantitative "acceptance criteria" for each test or detailed "reported device performance" against those criteria. It only states that these tests were conducted to "verify the performance characteristics."

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

• Sample Size for Test Set: Not applicable. Performance was verified through pre-clinical bench testing, not a clinical test set with human data. The document does not specify the number of devices or trials performed for each bench test.
• Data Provenance: Not applicable, as this was pre-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.

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

• Not applicable. This was pre-clinical bench testing of a physical device, not an AI/diagnostic device requiring expert ground truth for image or data interpretation.

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

• Not applicable. This was pre-clinical bench testing, not a study involving human readers or expert adjudication.

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 an arterial filter for cardiopulmonary bypass, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a physical arterial filter, not an algorithm.

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

• For pre-clinical bench testing, "ground truth" would equate to established engineering and material science standards and measurement techniques for evaluating physical properties (e.g., pressure, filtration size, material strength). The document implies that industry standards and validated methods were used to conduct the described performance tests, but it does not detail them.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set.

Summary of Device Acceptance & Study:

The "acceptance criteria" for this submission are primarily demonstrating substantial equivalence to the predicate device (Affinity Arterial Filter with Carmeda® BioActive Surface (20µm) Model CB353, K001138).

The study that "proves the device meets the acceptance criteria" is a series of pre-clinical bench tests. These tests were conducted to verify that despite a change in housing material (from polycarbonate to Bisphenol A-free (BPA-free) copolyester), the new device maintains similar technological characteristics, operating principles, design features, and performance as the predicate device. The conclusion of the submission states: "Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices."

The FDA's letter confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for market clearance under the 510(k) pathway.

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The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The provided text describes the K122760 submission for the Medtronic Affinity® AF100 Arterial Filter with Balance® Biosurface. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in the provided document. However, the study aimed to verify the performance characteristics through pre-clinical bench testing. The reported "performance" is that the device passed these tests, indicating it met Medtronic's internal criteria for safety and effectiveness, and thus demonstrated substantial equivalence to the predicate device.

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

• Sample Size: Not specified. The document only mentions "Pre-clinical bench testing."
• Data Provenance: The nature of "pre-clinical bench testing" implies that the data was generated in a controlled laboratory environment, likely at Medtronic, Inc. It is not patient data, so "country of origin" is not applicable in the same way as clinical studies. It is implicitly "prospective" bench testing, as it was conducted to verify the device's performance for this submission.

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

This section is not applicable. The device's performance was evaluated through physical and chemical bench tests, not through expert review of data such as medical images or clinical outcomes. Therefore, "ground truth" in the clinical sense, established by medical experts, was not required. The "ground truth" was determined by the objective results of the bench tests against predefined specifications.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. Since this study involved pre-clinical bench testing with objective measurements, an adjudication method was not needed.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable as the device is a physical medical device (an arterial filter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth was established through objective measurements and results from pre-clinical bench tests. These tests evaluated the physical and functional properties of the device against internal specifications and engineering standards for blood-contacting medical devices.

8. The Sample Size for the Training Set

This question is not applicable. As the device is a physical medical product, not an algorithm, there is no "training set."

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

This question is not applicable for the same reason as point 8.

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The Terumo® Pall AL20X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 20 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line and where the flow rate will not exceed 7 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.

The Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6 Arterial Filter, use the same principles of operation and technology. They perform their functions using two basic forms of technology. As filtration devices, particulates in the blood stream are captured and removed from the blood flow as blood passes through a porous filter material that is contained within the device housing. The filter establishes a physical barrier that entraps particulate matter and prevents it from moving downstream of the arterial filter assembly. As air-removal devices, the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, are designed so that air is removed from the blood stream as a result of centripetal force. The blood inlet port of the device is positioned on the upper-side axis of the polycarbonate housing, thereby creating a spiral blood flow pattern as blood enters the device. As the blood flows through the device in a spiral motion, centripetal forces cause the air bubbles to migrate towards the top of the housing assembly - where air can subsequently be purged from the circuit.

The provided text describes a 510(k) submission for a medical device, the Terumo® Pall AL20X Arterial Filter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for a novel functionality.

Therefore, the requested information regarding "acceptance criteria" for a study that "proves the device meets the acceptance criteria" in the context of AI/ML device assessment (which often involves performance metrics like sensitivity, specificity, AUC) is not directly applicable to this submission. This 510(k) primarily compares the new device to a predicate device based on in-vitro performance evaluations and design characteristics to argue for substantial equivalence.

However, I can extract the closest equivalent information from the provided text, interpreting "acceptance criteria" as the performance measures used to demonstrate equivalence to the predicate device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the way a modern AI/ML device might. Instead, it demonstrates performance equivalency to a predicate device through a series of in-vitro tests. The implied "acceptance criterion" is that the performance of the Terumo® Pall AL20X Arterial Filter is not significantly worse than the predicate device (Terumo® Pall AL6X Arterial Filter) for key operating parameters, and for some, it is even improved (e.g., smaller pore size).

Table of Performance Evaluations and Implied Comparison to Predicate:

Key Design Differences & Rationale for Equivalence:

• Filter Pore Size: AL20X has 20µm, AL6X (predicate) has 40µm. Smaller pore size is an improvement for micro-emboli removal. "Filter pore size of 20 um to 40 um for arterial line filters is standard to the industry."
• Maximum Flow Rate: AL20X has 7 L/min, AL6X (predicate) has 8 L/min. This difference is deemed "not clinically relevant" because "A blood flow rate of 7 L/min or less is typically used in Cariopulmonary Bypass procedures and most bypass components are only qualified to a maximum flow rate of 7 L/min."

Other Requested Information (Not directly applicable in the context of this 510(k) for an arterial filter, but addressed based on closest interpretation):

Since this is a submission for a physical medical device (arterial filter) and not an AI/ML diagnostic or prognostic tool, many of the requested fields are designed for AI/ML device evaluation and are not present in this document.

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

   • The document mentions "in-vitro performance evaluations," implying lab-based testing. It does not provide specific sample sizes (e.g., number of devices tested for each evaluation).
   • Provenance: The tests were conducted by Terumo Cardiovascular Systems ("Terumo Cardiovascular Systems conducted the following in-vitro performance evaluations...").
   • Retrospective or Prospective: These would be prospective in-vitro tests performed on manufactured devices.

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

   • Not applicable. This is an in-vitro device evaluation; ground truth would relate to physical measurements and engineering specifications, not expert interpretation of outputs.

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

   • Not applicable. This is an in-vitro device evaluation.

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:

   • Not applicable. This is not an AI-assisted device requiring human reader interaction.

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

   • Not applicable. This is a standalone physical medical device. The "performance evaluations" are effectively the standalone performance of the device without human interpretation.

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

   • For in-vitro tests, the "ground truth" is based on established engineering and scientific principles, measurement standards for parameters like pore size, flow rate, pressure drop, and material compatibility.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML model requiring a training set. Its design is based on established engineering principles and prior device iterations (predicate).

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

   • Not applicable. No training set for an AI/ML model.

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