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The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.

The OutFlo Aortic Valve Dilatation Balloon Catheter (marketing name: OutFlo) is a sterile, single use, Over-the-Wire (OTW) dual-lumen catheter with a hub at the proximal end and a balloon cluster at the distal end. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for blood flow. Thus, buildup of pressure in the ventricle is avoided. The dilation catheter is intended to be used in conjunction with a 14F or larger guiding catheter and a 0.035" or smaller guidewire, and Y-connectors, none of which are supplied by the manufacturer. The OutFlo Aortic Valve Dilatation Balloon Catheter is provided in five models. The only difference between the models are the balloon diameter.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text. It's important to note that the document is a 510(k) summary, which often provides high-level information rather than detailed study protocols. Therefore, some information might be missing or stated generally.

Device Name: OutFlo Aortic Valve Dilatation Balloon Catheter
Indications for Use: The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for the clinical study in a quantifiable manner (e.g., "X% success rate"). Instead, it describes the objectives and results. The primary clinical "acceptance criteria" can be inferred from the study's evaluation points.

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

• Sample Size (Clinical Test Set): 40 subjects.
• Data Provenance: The study was a "prospective, multi-center, observational study." The country of origin is not explicitly stated for the test data, but the submitter (DISA Medinotec) is based in Johannesburg, South Africa, which might be where some or all of the centers were located. However, this is an inference, not a stated fact.

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

The document states, "Performance of the device was evaluated by the investigators." It does not specify the number of individual experts per case or their specific qualifications (e.g., "radiologist with 10 years of experience"). "Investigators" typically refers to the physicians (e.g., interventional cardiologists) performing the procedures and assessing outcomes in a clinical trial. Given the nature of a valvuloplasty device, these would likely be highly experienced interventional cardiologists.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that "[p]erformance of the device was evaluated by the investigators." In a multi-center observational study, the primary investigators at each site would typically assess the outcomes for their patients. Central adjudication by an independent committee is common for clinical trials but is not mentioned here.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study was a clinical observational study of the device's performance, not a comparison of human readers' performance with and without AI assistance. The device in question is a medical device (balloon catheter), not an AI-powered diagnostic tool.

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

N/A. This question is not applicable as the device is a physical medical instrument (a balloon catheter) used by a human operator, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth was established by clinical observation and assessment by investigators. This includes:

• Procedural Success: Determined by the medical professionals performing and observing the valvuloplasty procedure.
• Major Adverse Events (MAE) and Death: Clinically observed and reported.
• Ability to Allow Blood Flow / Eliminate Pacing: Assessed during the procedure by the clinical team.

8. The Sample Size for the Training Set

N/A. The provided information pertains to the clinical performance study of a physical medical device. There is no mention of a "training set" in the context of an AI/machine learning model, as this device itself is not an AI algorithm. The training for the device itself would come from its engineering and design processes, and validation from bench and clinical testing.

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

N/A. As there is no AI/ML component or "training set" in the context of this device, this question is not applicable.

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The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway.

The D35 Airway Dilation Catheter (marketing name: Trachealator) is a sterile single-use device used during airway dilatation procedures. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for airflow. Thus, airway occlusion is avoided. The D35 Airway Dilation Catheter is also packaged with a double-ended PTFE-coated stainlesssteel guidewire. The guidewire consists of a two-tip configuration with a length of 1500 mm. One end has a straight tip configuration, while the other end consists of a J-tip with a 6 mm diameter. The catheter is also used with an inflation device that is not provided with the catheter. The D35 Airway Dilation Catheter is provided in nine models. The only differences between the models are the balloon length and diameter.

The provided text describes the 510(k) summary for the Trachealator (D35 Airway Dilation Catheter). It details the device, its intended use, comparison to predicate devices, and performance data. However, it explicitly states that clinical data and animal testing are "Not applicable" and "Clinical studies are not necessary to establish the substantial equivalence of this device."

Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or human expert evaluation. The performance data provided consists solely of bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than establishing clinical efficacy against specific acceptance criteria.

Below is a summary of the requested information based on the provided text, primarily focusing on the engineering and safety aspects for which data exists:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical acceptance criteria or corresponding clinical performance data are presented, this table will focus on the bench testing that was conducted to demonstrate device specifications and substantial equivalence. The document describes several tests performed but does not explicitly list "acceptance criteria" values for each, rather it states that "the D35 Airway Dilation Catheters performs as intended and that the catheter's meets their device specifications."

(Note: "Met device specifications" is inferred as the acceptance criteria for each bench test, as specific numerical criteria are not detailed in the provided text.)

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

• Test Set Sample Size: Not specified for any of the bench tests.
• Data Provenance: Not explicitly stated, but the submission is from DISA Medinotec, located in Johannesburg, South Africa. The testing was presumably conducted by or for the manufacturer. The data is retrospective in the context of this 510(k) submission.

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

• Not applicable. The document explicitly states that "Clinical Data" is "Not applicable." The ground truth for bench and biocompatibility tests is established by laboratory measurements against defined standards and internal device specifications, not by human experts adjudicating clinical cases.

4. Adjudication method for the test set

• Not applicable. No expert adjudication of clinical outcomes or diagnostic interpretations was performed as no clinical studies were deemed necessary.

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 (catheter) and does not involve AI or human readers for diagnostic interpretation.

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, not an algorithm.

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

• For the non-clinical performance evaluations (biocompatibility, sterilization, bench testing), the "ground truth" implicitly refers to adherence to established international standards (e.g., ISO) and the manufacturer's internal device specifications.

8. The sample size for the training set

• Not applicable. This device is a physical medical device; there is no "training set" in the context of an algorithm.

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

• Not applicable. There is no training set.

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