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Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

The Edwards Femoral Access Venous and Arterial Cannulae with/out Duraflo® coating are wire-reinforced thin-wall polyurethane or PVC cannulae. The wire reinforcement is intended to prevent kinking during use. The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for 1/4" or 3/8" tubing connection. The cannulae are available on various sizes and lengths. Each cannula is furnished with one, or in some cases two, dilator(s). In the case of cannulae supplied with two dilators, one is solid and the other is hollow. The hollow dilator will pass over guidewires up to 0.038" (0.97 mm) in diameter. The guidewire, when used, facilitates percutaneous insertion under direct visualization. The cannulae tips are tapered for easy insertion. Some cannulae feature incremental depth markings to aid in proper placement and positioning. Some versions have, as an additional aid to placement, the clear tip section of the cannula contain two radiopaque barium stripes for visualization. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

Here's an analysis of the provided text regarding the Edwards Lifesciences® Femoral Access Venous and Arterial Cannulae, focusing on acceptance criteria and study details.

Based solely on the provided 510(k) summary, the document does not contain the detailed study information typically associated with establishing device performance against specific acceptance criteria. The 510(k) summary explicitly states that the basis for the submission is the addition of contraindications to the Instructions for Use, and that no physical changes are being made to the devices. It claims substantial equivalence to previously cleared predicates without providing new performance data for this submission.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be extracted from this document because such a study is not detailed here.

Here's a breakdown of what can be inferred or explicitly stated from the provided text:

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

Explanation: The 510(k) summary, in this instance, is focused on a labeling change (adding contraindications) rather than demonstrating new performance. It relies on the prior clearance of its predicate devices to assert that the device "met all predetermined acceptance criteria." The specific criteria and the data proving performance against them are not included in this document.

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: Not specified in this 510(k) summary.
• Data Provenance: Not specified in this 510(k) summary.
• Retrospective/Prospective: Not specified in this 510(k) summary.

Explanation: Since no new performance studies are detailed, this information is not available in the provided text.

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/Not specified in this 510(k) summary, as no new clinical or performance studies requiring expert ground truth establishment are detailed.

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

• Not applicable/Not specified in this 510(k) summary.

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 device (cannulae), not an AI/software-based diagnostic tool that would typically involve human readers or AI assistance.

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

• Not applicable. This device is a physical medical device.

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

• Not applicable/Not specified in this 510(k) summary. For a physical device like a cannula, "ground truth" would typically relate to mechanical properties, biocompatibility, flow rates, and successful implantation/function in in vitro or in vivo studies, data which are not presented here.

8. The sample size for the training set

• Not applicable/Not specified in this 510(k) summary, as no AI model or complex algorithm requiring a training set is discussed.

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

• Not applicable/Not specified in this 510(k) summary.

Summary of Findings from the Provided Text:

The provided 510(k) summary (K140208) is a submission primarily focused on labeling changes (adding contraindications) for existing, previously cleared devices. It explicitly states that "No physical changes are being made to these devices" and that the "design of the device remains unchanged." The basis for clearance is substantial equivalence to predicate devices (K123298 and K123303), which would have had their own studies (mechanical, biocompatibility, etc.) for initial clearance. This particular document does not present any new acceptance criteria or new data from studies to prove device performance. It simply asserts that the device "met all predetermined acceptance criteria" based on its equivalence and prior clearances.

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The VFE assay is an in vitro enzyme immunoassay for quantifying the concentration of von Willebrand Factor Antigen in human plasma to aid in differentiating patients with von Willebrand disease from those with Classical Hemophilia A.

VFE is an enzyme immunoassay, in microplate format, intended for the in vitro quantification of von Willebrand Factor antigen in serum or plasma as an aid to differentiate patients with von Willebrand disease from those with classical Hemophilia A. This assay represents an updated technical format, with performance improvements, when compared to the predicate device.

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Device: VFE (von Willebrand Factor Antigen Assay)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a comparison to a predicate device (SPECTRO vWF) to demonstrate "substantial equivalence." The performance parameters of the VFE are compared to those of the predicate. We can infer that the VFE's performance should be comparable to or better than the predicate's for "substantial equivalence."

Note on Sensitivity: The VFE's reported sensitivity (0.78% N) is higher than SPECTRO vWF's (0.23% N). In this context, a higher percentage might indicate a detection limit, where a lower percentage is generally better for sensitivity in an assay (meaning it can detect lower concentrations). However, without further context on the specific units and definition of "% N," it's difficult to definitively say if VFE is "better" or if it represents a different measure. The conclusion statement indicates "similar characteristics," suggesting this difference was not considered a deal-breaker for substantial equivalence.

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

• Sample Size for Accuracy (compared to predicate): 118 samples (n = 118)
• Data Provenance: Not explicitly stated. The comparison is made to a predicate test, "SPECTRO vWF," which is also from Ramco Laboratories, Inc. No information regarding the country of origin or whether the data was retrospective or prospective is provided.

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

• This information is not provided in the document. The accuracy of the VFE is compared to results from the predicate device, and the predicate's accuracy was "original comparison versus Laurell Rocket electrophoresis results." There is no mention of experts establishing a ground truth.

4. Adjudication Method for the Test Set

• This information is not provided. The comparison is statistical (R value) against a predicate device's results.

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

• No. This device is an in vitro diagnostic (IVD) enzyme immunoassay, not an AI-powered diagnostic imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable.

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

• Yes, implicitly. The performance data presented (sensitivity, reproducibility, accuracy) represents the standalone performance of the VFE assay itself, without human interpretation in the sense of a "human-in-the-loop" for image or complex data analysis. The assay produces a quantitative result.

7. The Type of Ground Truth Used

• For the VFE's accuracy, the ground truth was the results obtained from the predicate device (SPECTRO vWF).
• For the predicate device's original accuracy, the ground truth was derived from Laurell Rocket electrophoresis results.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The VFE is an enzyme immunoassay, not a machine learning model that requires a "training set" in the conventional sense. The "training" of an assay involves optimization during development, but specific sample sizes for such an activity are not documented in the same way as for AI models.

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

• Not applicable/not provided. As mentioned above, this is an immunoassay, not an AI model.

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Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress.

Standard vacuum extraction

Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions.

Trial of vacuum extraction

Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known.

Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.

The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).

The provided text describes the Kiwi Fetal Vacuum Extractor and its 510(k) submission for market clearance. While it discusses the device's intended use, basic technological characteristics, and comparison to predicate devices, it does not provide detailed acceptance criteria or a specific study that proves the device meets such criteria.

The text generally states:

• "The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing."
• "Biocompatibility testing shows that the materials used in the Kiwi Fetal Vacuum Extractors are safe for this application."
• "Effectiveness is the same as the predicate devices."
• "The laboratory testing verified the performance in terms of vacuum measurement and device integrity."

However, it lacks the specific data points to fill a comprehensive table of acceptance criteria and reported performance, nor does it detail the methodology, sample sizes, ground truth establishment, or expert involvement for the referred "clinical testing" or "laboratory testing."

Therefore, I cannot fulfill all parts of your request based on the provided input.

Here's what can be inferred and what is missing:

Acceptance Criteria and Study Details for Kiwi Fetal Vacuum Extractor

Missing Information: The provided document is a 510(k) summary and FDA clearance letter. It states that "clinical testing" and "laboratory testing" were performed to demonstrate safety and effectiveness similar to predicate devices, and that "laboratory testing verified the performance in terms of vacuum measurement and device integrity." However, it does not provide specific acceptance criteria, detailed results, study designs, sample sizes, or ground truth methodologies for these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Performance/Effectiveness (Inferred/General statements):

Note: Specific quantitative acceptance thresholds (e.g., vacuum pressure range, force limits, successful delivery rates) and actual measured performance values are not provided in this document.

The remaining sections cannot be addressed with specific details from the provided document as the information is not present.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature of the clinical/laboratory testing).

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

• Not specified, as details of clinical or laboratory study design are absent.

4. Adjudication method for the test set

• Not specified.

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/Not specified. This device is a physical medical instrument (fetal vacuum extractor), not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a physical instrument for use by a clinician.

7. The type of ground truth used

• Not explicitly stated for the clinical or laboratory tests. For an interventional device like a vacuum extractor, ground truth would typically relate to successful delivery, Apgar scores, maternal/fetal complications, and physical integrity/functionality of the device.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device requiring a training set.

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

• Not applicable.

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