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The Biowy Tym Tube products are indicated for where chronic Eustachian tube dysfunction does not respond to conventional therapy.

The tympanostomy tube is a silicone tube that is intended to provide ventilation and drainage to the middle ear.

The provided text describes the Biowy Tym Tube, a tympanostomy tube, and its 510(k) summary for substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets clinical acceptance criteria in the context of an AI/ML device.

The provided information focuses on engineering and biocompatibility testing for a physical medical device, not a software or AI/ML product. Therefore, I cannot extract the requested details relevant to AI/ML device performance or clinical studies using AI models.

To answer your request, here's an analysis based solely on the information provided, which is limited to the physical device's characteristics and safety testing:

Based on the provided document, the "device" in question is the Biowy Tym Tube, a physical tympanostomy tube, not an AI/ML software device. The acceptance criteria and "study" described pertain to the physical properties, sterility, and biocompatibility of this physical device.

Here's the information extracted from the document:

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

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:
  • Pyrogenicity: "Three production lots of the test article identified as Biowy Tym Tube" were validated.
  • Bench Testing (Visual, Compression, Tensile): Not explicitly stated, but typically involves a sample size representative of production for such physical tests.
  • Biocompatibility: Not explicitly stated, but ISO 10993 testing requires specific sample sizes depending on the test.
• Data Provenance: Not specified. This type of testing is typically performed by internal or contract labs and is generally considered part of the manufacturing quality control and design verification process, not clinical data.

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 and not provided in the document. The tests performed are engineering, chemical, and biological safety tests, not clinical evaluations requiring expert interpretation (like a radiologist establishing ground truth for image analysis).

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews of complex data (e.g., medical images, clinical outcomes) to resolve discrepancies. The described tests are objective measurements against defined standards.

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 and not provided. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI/ML devices involving human readers. The Biowy Tym Tube is a physical medical device, not an AI/ML system.

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

This information is not applicable and not provided. This concept applies to standalone AI/ML algorithms. The described device is a physical product.

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

The "ground truth" for the tests mentioned are:

• Sterility: Absence of microorganisms (verified through validated sterilization processes).
• Pyrogenicity: Absence of pyrogens/endotoxins (quantified via LAL test).
• Visual Inspection: Conformance to manufacturing specifications (e.g., no cracks, burrs, malformations).
• Compression/Tensile: Objective physical measurements against defined engineering specifications and comparison to the predicate device.
• Biocompatibility: Absence of adverse biological reactions (measured via ISO 10993 tests for cytotoxicity, sensitization, irritation, etc.).

These are objective, measurable standards for a physical product, not clinical "ground truth" derived from patient data or expert interpretation.

8. The sample size for the training set:

This information is not applicable and not provided. A "training set" is relevant for AI/ML models. This document describes a physical medical device.

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

This information is not applicable and not provided. This concept is for AI/ML models.

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The Biowy PICC catheter S Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. The catheter is available in a kit configuration.

The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters. The catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. The Catheter is provided in a kit with multiple components that includes a stylet, torque adapter and T-lock to facilitate catheter insertion and flushing which are subject to this submission. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. The catheter and other components in the kit are unchanged from the predicate device.

This document is a 510(k) Pre-market Notification for a medical device (Biowy PICC Catheter S Kit), not a study proving a device meets AI-related acceptance criteria. Therefore, most of the requested information regarding AI acceptance criteria and study design for AI performance evaluation is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device (Biowy PICC Catheter K173956) based on non-clinical bench testing for the physical catheter and its new accessories.

Here's the information that can be extracted, and where the requested information is not applicable (N/A) because the document describes a traditional medical device clearance, not an AI/ML powered device:

Device: Biowy PICC Catheter S Kit (K192246)
Type of Device: Percutaneous, implanted, long-term intravascular catheter (PICC)

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Tests" and "Results" which indicate whether the device "Passed" or "Met requirements" for various physical and material properties. These are not acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).

Since this is not an AI-powered device, the following points are Not Applicable (N/A) to the information provided in the document:

2. Sample size used for the test set and the data provenance: N/A (No AI test set described)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No AI ground truth establishment described)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No AI test set 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: N/A (Not an AI-assisted device)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Ground truth as understood for AI performance is not relevant here. "Ground truth" for this device's performance is based on physical property testing and material standards.)

8. The sample size for the training set: N/A (No AI training set described)

9. How the ground truth for the training set was established: N/A (No AI training set described)

Summary for this document: The provided text is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through non-clinical bench testing of the device's physical properties and materials against established medical device standards. It does not involve artificial intelligence, machine learning, or associated performance metrics and study designs that would typically address the questions posed about AI acceptance criteria and studies.

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The Biowy PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi.

The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device.

The provided document is a 510(k) summary for the Biowy PICC Catheter, which is a medical device and not an AI/ML software device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, number of experts for ground truth, adjudication methods, or training set details are not applicable in this context. The acceptance criteria and performance are based on physical and biological testing of the catheter.

Here's the information pulled from the document regarding the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the sample sizes for each specific test. The data provenance is not mentioned, and tests appear to be laboratory-based design verification rather than clinical data from human subjects. The study is a non-clinical performance test.

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, as this is a medical device clearance based on non-clinical performance testing and biocompatibility, not an AI/ML algorithm requiring expert ground truth for interpretation of images or other data.

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

Not applicable. This type of adjudication is for studies involving human interpretation or assessments, such as in clinical trials or AI/ML evaluations.

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 for AI/ML software devices, not a physical medical device like a PICC catheter.

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

Not applicable. This is for AI/ML software devices, not a physical medical device.

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

The "ground truth" for this device is based on established engineering and biological standards (e.g., ISO, ASTM, USP). The device's performance is compared against these predetermined specifications and, in some cases for biocompatibility, against a legally marketed predicate device (5Fr DL PowerPICC® Catheter, K051672).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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