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The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.

The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.

The provided text describes the MiniGuard™ Arterial Safety Valve, outlining its intended use, technological characteristics, and performance data to support its substantial equivalence to a predicate device (RetroGuard Arterial Safety Valve, K922356). However, the document does NOT contain explicit acceptance criteria defined by specific numerical thresholds for each test, nor a detailed study that directly "proves" the device meets these criteria in the typical sense of a clinical trial or a statistically powered performance study against pre-defined metrics.

Instead, the document states: "Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance." This implies that internal specifications were met, but these specifications are not explicitly detailed for each test.

Therefore, the following information is extracted or inferred based on the provided text. Many fields cannot be directly answered due to the nature of the available document, which is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Acceptance Criteria and Reported Device Performance

Note: The document only states that the device "meets all established specifications necessary for consistent performance." It does not provide the specific numerical values for these specifications (e.g., "Opening pressure < X mmHg") nor the exact reported performance values (e.g., "Opening pressure was Y mmHg").

Additional Study Information:

1. Sample size used for the test set and the data provenance: Not specified. The document mentions "performance testing" but does not detail the number of units tested for each parameter or the origin of any data (e.g., country, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable / Not specified. This device is a mechanical valve, so "ground truth" as typically applied to diagnostic AI algorithms involving human expert interpretation is not relevant here. The ground truth for its performance would be determined by direct physical measurement and engineering testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. See point 2.
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 device is a mechanical valve; it is not an AI-based diagnostic tool that assists human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm. Its performance is inherently "standalone" in the sense that it operates without human intervention once installed in the circuit.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on direct physical measurement and engineering testing against predefined industrial/performance specifications (e.g., flow rates, pressure, leak integrity).
7. The sample size for the training set: Not applicable. This is a mechanical device, not an AI model that requires a training set.
8. How the ground truth for the training set was established: Not applicable. See point 7.

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The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.

The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.

The Advanced Surgical Intervention (ASI) Miniguard Female Continence Device was evaluated for its safety and efficacy in decreasing urinary leakage episodes and improving quality of life in women with stress incontinence.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail format per se, but rather presents the statistically significant improvements as the measure of effectiveness. I've re-framed the reported performance as meeting implied criteria for significant improvement.

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

• Test Set Sample Size: Over 350 women.
  • Broken down by incontinence severity: 124 women (mild), 163 women (moderate), and 69 women (severe).
• Data Provenance: The study was conducted from 12 investigative centers in the United States. It was a prospective study, as women used the device during a 12-week device usage period, with data collected before (Control) and after (Trial 17) this period.

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

The document does not specify the number of experts used to establish the ground truth for the test set efficacy outcomes. The efficacy data (number of leakage episodes, perceived severity, quality of life impact, quantity of leakage) were derived from participant-completed voiding diaries, symptom questionnaires, incontinence impact questionnaires, and 12-hour home pad-weight tests. These are subjective and objective measures directly from participants, not externally interpreted "ground truth" established by experts in the same way, for example, a diagnosis from an image would be.

However, for safety data analysis, independent expert teams were utilized:

• Bladder function data: Assessed by leading urologists and urogynecologists.
• Microbiology data: Assessed by a core laboratory at the University of Washington specializing in urogenital microflora.
• Dermatology data: Assessed by an expert in dermatology and gynecology at Emory University.
  The specific number of experts within these teams is not provided, nor are their years of experience explicitly stated beyond "leading" and "expert."

4. Adjudication method for the test set:

Not applicable in the context of this device. The "test set" involves patient-reported outcomes and objective measurements (pad-weight test) over time, rather than discrete classifications requiring adjudicators. Clinical outcome parameters were statistically analyzed (paired-t analyses, repeated-measures MANOVA), not adjudicated.

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 is not an AI-based diagnostic device. The study evaluates the effectiveness of a physical continence device for patients, not the performance of human readers of medical images or data.

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

Not applicable. This is a physical medical device for managing incontinence, not an algorithm.

7. The type of ground truth used:

The "ground truth" for efficacy was established through a combination of:

• Patient-reported outcomes: Voiding diaries, symptom questionnaires, and incontinence impact questionnaires. These reflect the patient's subjective experience and perception of their condition.
• Objective measurement: 12-hour home pad-weight tests to quantify urine leakage.

For safety, the ground truth was based on medical assessments (post-void residual measurements, cystometry, vaginal smears, vaginal and urine cultures, urinalysis, physical examinations, vestibular cytology), confirmed by independent expert review.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The clinical study of 350+ women served as the primary evidence for the device's performance.

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

Not applicable, as there is no training set for a machine learning algorithm.

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