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Intended for use in the approximation of soft tissue and prosthetic materials.

The ThruPort Knotting Instrument is used in conjunction with 2-0 polyester or 2-0 polypropylene suture and a knot loader with nitinol knot and is indicated for use in the approximation of soft tissue and prosthetic materials.

Edwards Lifesciences' ThruPort OptiClip Knotting System is a sterile, nonpyrogenic, single-use surgical instrument made of metal and polymeric materials. lt consists of the ThruPort OptiClip Knotting Instrument and the ThruPort OptiClip Knot Loader.

This document describes the regulatory approval for the Edwards ThruPort OptiClip Knotting System. It is a not a clinical study report and therefore does not contain information about acceptance criteria or device performance as would be expected for a clinical study.

However, it does describe the functional and safety testing performed, and that all results met acceptance criteria. It also details the MR safety information testing.

Here's an analysis of the provided text based on your request, highlighting what is available and what is not:

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

This information is not provided in a table format, nor are specific quantitative acceptance criteria or reported performance values given. The document states: "The functional data indicate that the device performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were completed and all results met acceptance criteria." This implies that acceptance criteria were defined and met, but the specific details are not disclosed.

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

This information is not provided. The document describes "Functional bench testing (design verification)" and "Non-clinical testing" for MR Conditional assessment. It does not mention a "test set" in the context of human subjects or clinical data. All testing appears to be laboratory-based verification and validation.

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/provided. The testing performed is functional and safety testing, not diagnostic performance evaluation requiring expert ground truth.

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

This information is not applicable/provided. Adjudication methods are typically associated with clinical studies involving human observers or image interpretation, which is not the nature of the testing described.

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 information is not applicable/provided. This device is a surgical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

This information is not applicable/provided. This device is a medical instrument and does not involve an algorithm or AI.

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

For the functional and safety testing, the "ground truth" would be the engineering specifications, established medical device standards (e.g., ISO 10993-1:2009 for biocompatibility), and internal design requirements. For MR safety, the ground truth is based on established physics principles and testing methodologies for MR compatibility. There is no biological or diagnostic "ground truth" in the clinical sense mentioned in the document.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/provided for the same reason as point 8.

Summary of available information related to acceptance criteria and study (non-clinical):

The document describes several non-clinical tests (functional bench testing, MR evaluation testing, biocompatibility, sterility, shelf life, packaging, design validation) performed to demonstrate that the device is substantially equivalent to a predicate device and meets safety and effectiveness requirements.

• Acceptance Criteria Overview: The document broadly states that "all results met acceptance criteria" for the functional tests. For MR safety, specific conditions for MR Conditional use are provided (static magnetic field, spatial gradient, SAR, temperature rise, and image artifact size), which serve as the acceptance criteria for claiming MR Conditional status.
• Study Type: Non-clinical (laboratory/bench) testing for design verification and validation.
• MR Evaluation Testing:
  • Acceptance Criteria (as stated in the document):
    • Static magnetic field must be 1.5 Tesla and 3.0 Tesla only.
    • Maximum spatial gradient magnetic field of 3,000 Gauss/cm (30 T/m) or less.
    • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode).
    • Maximum temperature rise of less than 1.5 ℃ after 15 minutes of continuous scanning.
    • Image artifact caused by the nitinol knot extends approximately 1 mm from the knot with a spin echo pulse sequence in a 3.0 T MRI system, and 5 mm with a gradient echo pulse sequence in a 3.0 T MRI system.
  • Reported Device Performance (as stated in the document): The device (specifically the nitinol knot) meets these conditions and is therefore classified as "MR Conditional." The image artifact characteristics are also reported.
  • Sample Size for Test Set: Not explicitly stated, but typical for non-clinical MR testing, it would involve a specific number of device samples.
  • Data Provenance: Non-clinical (laboratory testing).
  • Ground Truth: Engineering specifications and established MR safety testing standards.

In conclusion, this document primarily serves as a regulatory clearance letter and a 510(k) summary, detailing the types of tests performed to achieve substantial equivalence. It does not provide the granular details of acceptance criteria and performance data typically found in a clinical study report for diagnostic devices.

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

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

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

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

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

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

Device: Edwards Lifesciences Research Medical Inc. Pediatric Arterial Cannulae

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

7. The type of ground truth used

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

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

8. The sample size for the training set

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

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

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

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The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.

The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium.

The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations.

The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

The ERMI Pediatric Venous Return Cannulae are used to access the vena cavae or femoral vein during cardiopulmonary bypass.

This 510(k) submission describes the Edwards Lifesciences Research Medical Inc. Pediatric Venous Return Cannulae. It refers to a comparative analysis and functional/safety testing, but does not provide specific acceptance criteria or detailed study results in the provided text.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present in the provided document:

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

Missing Information: The document does not explicitly state the acceptance criteria (e.g., minimum flow rates, pressure resistance, biocompatibility standards, etc.) or detailed numerical performance data for functional and safety testing.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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 section is not applicable as the device is a medical cannulae, not an AI/diagnostic imaging device that requires expert-established ground truth for its performance evaluation (e.g., in terms of accuracy, sensitivity, specificity). The testing would involve engineering and biocompatibility evaluations.

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

Not applicable for a medical device of this type. Adjudication methods are typically relevant for complex diagnostic interpretations or clinical endpoints where inter-rater variability might be a factor.

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 medical instrument, not an AI-assisted diagnostic tool.

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

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

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

Not applicable. The "ground truth" for a device like this would be established through engineering specifications, material standards, and validated testing methodologies to ensure it meets its intended functional and safety requirements.

8. The sample size for the training set

Not applicable. There is no training set involved for this type of medical device as it is not an AI/machine learning product.

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

Not applicable. There is no training set involved.

Summary of what the document does provide regarding the study:

• Study Title/Description: "Functional/Safety Testing" and "Biocompatibility Testing."
• Conclusion of Testing: The ERMI Pediatric Venous Return Cannulae "have successfully undergone functional and biocompatibility testing."
• Comparative Analysis: The primary "study" in this context is a comparative analysis against predicate devices. The document states: "The only difference between the subject catheters and the predicate Research Medical catheters is the subject catheters are smaller in diameter and length. Aside from the smaller sizes, there is no difference between the ERMI Pediatric Venous Return Cannulae and the predicate devices." This implies that the performance of the new device is expected to be similar to the predicate devices due to their fundamental similarity, with the primary change being size.
• Substantial Equivalence: Based on the comparative analysis and the successful functional/biocompatibility testing, the conclusion is that the ERMI Pediatric Venous Return Cannulae are "substantially equivalent to the predicate devices."

In essence, the provided document focuses on demonstrating substantial equivalence to predicate devices through a comparative analysis and successful completion of standard functional and biocompatibility testing, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for novel diagnostic or therapeutic devices.

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