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The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for

Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.

The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.

The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.

The provided 510(k) summary for the Edwards Lifesciences Arterial Perfusion Cannula II does not contain the kind of detailed information about acceptance criteria, study design, expert ground truth, or statistical analyses that would typically be found in a submission for a device that uses AI or machine learning.

This submission is for a medical device that is a physical product (an arterial perfusion cannula), and its safety and efficacy are demonstrated through comparative analysis and functional/safety testing against a predicate device, not through studies involving AI or complex data analysis with expert consensus.

Therefore, I cannot extract the requested information as it is not present in the provided document.

Here's why and what kind of information is available instead:

• Acceptance Criteria & Device Performance: The document states that the "functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device." This implies the acceptance criteria were met if the new device's functional performance was deemed equivalent to the predicate. Specific numerical targets or performance metrics are not provided, as this is a traditional medical device submission focused on physical characteristics and performance.
• Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Functional/Safety Testing" and "Comparative Analysis." These studies demonstrate that the new APC II cannulae are "comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations."
• Points 2-9 (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set, etc.): These points are specific to studies involving algorithms, data analysis, and expert interpretation (common in AI/ML submissions). They are entirely absent because this submission is for a physical medical device. The "ground truth" for a physical device like a cannula would be its physical integrity, material properties, flow rates, pressure resistance, etc., which are assessed through engineering and bench testing, not expert consensus on interpretations of data.

In summary, the provided text describes a 510(k) submission for a physical medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML study design and ground truth are not applicable and cannot be answered from the given information.

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The Embol-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.

The EMBOL-X Intra-aortic Filter is provided in a cartridge that locks into the filter lumen of the EMBOL-X Access Device/Aortic Cannula, and is inserted through the lumen by depressing a syringe like plunger mechanism. The filter then opens to fill the diameter of the ascending aorta. The filter is intended to be inserted temporarily during CPB. Filters are manufactured in 5 sizes to conform to patient anatomy.

This document is a 510(k) summary for the Edwards Lifesciences EMBOL-X Intra-aortic Filter. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for establishing new performance criteria through a standalone study.

Therefore, many of the requested details about acceptance criteria and a study proving a device meets them are not applicable to this type of submission. This document focuses on demonstrating comparability to an already legally marketed device.

Here's a breakdown of the relevant information provided:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for this device. The core "acceptance criterion" for a 510(k) is substantial equivalence to a predicate device.
   • Reported Device Performance:

     Characteristic	Reported Performance (via comparison to predicate)
     Design	Comparable
     Intended Use	Comparable
     Materials	Comparable
     Principle of Operation	Comparable

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

   • Not applicable. This submission is based on a comparison to a predicate device, not on a new clinical or performance study that would generate a test set with a specific sample size. The "Functional/Safety Testing" section explicitly states: "Not required for this change. Safety data are not new for this change."

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):

   • Not applicable. See point 2.

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

   • Not applicable. See point 2.

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 physical intra-aortic filter, not an AI-driven diagnostic or assistive technology.

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

   • Not applicable. This device is a physical intra-aortic filter, not a software algorithm.

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

   • Not applicable. The "ground truth" for this 510(k) is the existing understanding and performance of the predicate device.

8. The sample size for the training set:

   • Not applicable. No new training set or study was conducted for this 510(k). The device relies on demonstrating equivalence to an existing product.

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

   • Not applicable. See point 8.

Summary of the Study (Comparison to Predicate Device):

The "study" or justification presented in this 510(k) is a comparative analysis demonstrating that the EMBOL-X Intra-aortic Filter is substantially equivalent to its predicate device (also named EMBOL-X Intra-aortic Filters). This comparison is based on:

• Design
• Intended use
• Materials
• Principle of operation

The submission explicitly states: "Functional/Safety Testing: Not required for this change. Safety data are not new for this change." This indicates that no new performance or safety studies were conducted specifically for this 510(k) application. The FDA's letter confirms substantial equivalence, allowing the device to be marketed.

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The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

The T-AnastaFic is a sterile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. Another silicone tubular shaft is attached perpendicular to the middle of the shunt, ending with a perfusion port stopcock. Each T-AnastaFlo is individually packaged sterile and non-pyrogenic in a sealed, peeltype pouch.

The T-AnastaFlo device received FDA clearance (K990396) based on substantial equivalence to the Rivetti-Levinson Intraluminal Shunt (K972261). The clearance was based on demonstrating equivalence in intended use, technology, materials, and design, supported by performance testing.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary (K990396) for the T-AnastaFlo device focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that the conclusion is "based upon tests performed for device flow rate, leak characteristics, and tensile strength, and upon the equivalence of materials, design and intended use for the proposed and predicate devices." However, the document does not provide the specific acceptance criteria or the numerical results of these tests, nor does it specify the predicate device's performance numbers that were used for comparison. The assumption is that the new device met performance characteristics deemed equivalent to the predicate.

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

The provided 510(k) summary does not specify:

• The exact sample sizes used for the flow rate, leak characteristics, and tensile strength tests.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

This information is not applicable and not provided in the 510(k) summary. The T-AnastaFlo is a medical device (intraluminal shunt), not an AI or diagnostic imaging device that typically requires expert-established ground truths for performance evaluation. The evaluation was based on engineering and material performance tests.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical trials or studies involving human interpretation or subjective endpoints, which is not the primary focus of this type of device clearance (mechanical performance).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging devices where human readers' performance is augmented by AI. The T-AnastaFlo is a mechanical surgical device.

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

This information is not applicable. The T-AnastaFlo is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for its evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the T-AnastaFlo's performance was established through engineering and material testing standards, comparing its physical properties (flow rate, leak characteristics, tensile strength) and material/design specifications against the predicate device. It was not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on meeting pre-defined mechanical and material specifications assumed to be safe and effective based on the predicate.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The T-AnastaFlo is not an AI-driven device, so there is no "training set."

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

This information is not applicable and not provided. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

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The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively.

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

This device is for short-term use only (

The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch.

The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.

Here's an analysis of the provided text regarding the Retrograde Cardioplegia Cannula with Duraflo Treatment, focusing on acceptance criteria and supporting studies.

It's important to note that the provided 510(k) summary (K991170) does not contain the detailed information typically associated with acceptance criteria and studies demonstrating device performance against those criteria as would be expected for an AI/ML or diagnostic device. This document is for a physical medical device (a catheter) and relies on substantial equivalence to predicate devices, rather than primary performance studies in the way you might be expecting.

Therefore, I will interpret your request within the context of what information is available in this 510(k) submission for a non-AI device.

Acceptance Criteria and Study for Retrograde Cardioplegia Cannula with Duraflo Treatment (K991170)

Given that this 510(k) is for a physical medical device (a cannula) rather than a software or diagnostic device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" is framed differently. The primary mechanism for clearance in this case is demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" being evaluated is whether the new device functions similarly and is as safe and effective as the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood or cardioplegic solution. Placement of the cannula may be performed either through the jugular vein or intraoperatively.

The BRMI Peripheral Retrograde Cannula is a triple lumen radiopaque cannula. The distal tip contains multiple infusion holes and a separate pressure monitoring lumen that terminates at a 3-way stopcock. A soft, low-pressure, manually inflated and deflated silicone occlusion balloon surrounds the distal body (proximal to the flow holes). The cannula has approximately 50cm of usable lumen length. Each Peripheral Retrograde Cannula is individually packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

This document is a 510(k) summary for a medical device (Peripheral Retrograde Cardioplegia Cannula). It does not contain information about studies to prove acceptance criteria, as this type of device (a cannula) is typically cleared based on substantial equivalence to predicate devices rather than clinical performance studies with acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: What the device is and its components.
• Intended Use: How the device is meant to be used.
• Predicate Devices: Comparison to similar devices already on the market to demonstrate substantial equivalence.
• Regulatory Classification: The FDA's classification of the device.

There is no mention of:

• Acceptance criteria for performance.
• Any studies (clinical or otherwise) with sample sizes, data provenance, ground truth establishment, expert adjudication, or MRMC/standalone performance.

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The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.

A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator. BRMI will offer the cannula in the following ranges: Size: 16 - 24 Fr. Length: 12" - 20.5'

The provided text describes a 510(k) premarket notification for the BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel, high-risk device would.

However, based on the information provided, we can infer the acceptance criteria and the "study" (biocompatibility assessment and comparative analysis) that proves the device meets those criteria.

Here's an analysis structured according to your request, with "N/A" for information not present in the provided document:

Acceptance Criteria and Device Performance Study for BRMI Venous Flex II Cannulae

This submission focuses on demonstrating substantial equivalence to predicate devices. The acceptance criteria are primarily related to biocompatibility and comparative specifications, aiming to show that the new device is as safe and effective as the previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Biocompatibility Testing: The document refers to "whole product extract and/or tubesheet slices," "the test article," and "the test group and negative control animals." Specific numerical sample sizes (e.g., number of animals, number of samples per test) are not provided.
• Data Provenance: The biocompatibility testing was performed on a test article that is "substantially equivalent in design and materials" to the proposed device, specifically "The FEM II-xxx-A was used as the test article for this testing." This suggests internal company testing rather than external clinical data. The country of origin for the data is not specified. It appears to be retrospective in the sense that results from previous testing of a similar device (FEM II-xxx-A) are being used to support the current device.

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

• Experts for Biocompatibility Ground Truth: N/A. Biocompatibility testing relies on standardized laboratory procedures and protocols (e.g., ISO 10993, CFR Title 16 Part 1500.41, USP Systemic Injection Test). The "ground truth" is established by the pass/fail criteria defined within these international and national standards. No human experts are explicitly mentioned as establishing the "ground truth" for the test results themselves in the context of interpreting the raw test data against qualitative standards. The tests are objective.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. For these standardized, objective laboratory tests, there is no mention of a human adjudication process. The results are typically interpreted against predetermined thresholds or qualitative observations (e.g., presence/absence of cytotoxicity, signs of sensitization).

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

• MRMC Study: No. This type of study (MRMC) is typically relevant for diagnostic imaging or screening devices where human readers interpret results, often with and without AI assistance. This submission is for a medical cannula, and as such, an MRMC study is not applicable and was not performed.

6. Standalone Performance Study

• Standalone Performance (Algorithm Only): No. This device is a physical medical instrument (a cannula), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" is not applicable. The "performance" is assessed through its material properties, design specifications, and biological compatibility.

7. Type of Ground Truth Used

• Ground Truth Type: For biocompatibility, the "ground truth" is based on established scientific and regulatory standards and objective laboratory measurements. These include:
  • Cytotoxicity: Cell viability and growth observed under specific test conditions.
  • Sensitization: Absence of allergic reactions in animal models.
  • Irritation: Absence of inflammation or adverse reactions in animal models.
  • Systemic Toxicity: Absence of systemic adverse effects in animal models.
  • Hemolysis: Percentage of red blood cell lysis.
• For the comparative information (Table 1), the "ground truth" is the specifications and characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: N/A. This 510(k) submission does not describe a machine learning algorithm or AI model that would require a "training set." The device is a physical product.

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

• Ground Truth for Training Set Establishment: N/A. As there is no training set for an AI model, this question is not applicable.

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