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The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.

The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.

The Dillard Nasal Balloon (DNB) Catheter has a total length of either 25cm or 100cm and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.

The Dillard Nasal Balloon Catheter (DNB) is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The provided document does not explicitly present a table of "acceptance criteria" with numerical targets and the device's reported performance against those targets in the context of an algorithmic or AI-driven device. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to a predicate device. The "reported device performance" is generally stated as the device performing "as intended" and being "as safe and as effective as the predicate device."

Here's an interpretation of relevant performance characteristics and implicitly met criteria:

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of an AI/algorithmic evaluation. The performance tests mentioned include:
  • Simulated use in cadavers: The sample size for cadavers is not specified.
  • Other performance tests (dimensional, strength, burst pressure, etc.): These typically involve a statistically relevant number of manufactured devices, but the specific quantity is not disclosed.
• Data Provenance: Not applicable in the context of typical AI data provenance (country of origin, retrospective/prospective). The data comes from direct physical testing of the device and its components.

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

This device is a physical medical instrument, not an AI/algorithmic device requiring an expert-established "ground truth" in the way an image analysis algorithm would. The "ground truth" for its performance is established through engineering and biological testing standards and clinical observation (in cadavers). There is no mention of external experts establishing ground truth for the test set.

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

Not applicable. This is not an AI/algorithmic device where adjudication of interpretations would be necessary. The performance tests yield objective physical measurements or observations.

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 not an AI-assisted diagnostic or interpretative tool, so an MRMC study and effect size in improving human reader performance is not relevant.

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

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

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

The "ground truth" for the Dillard Nasal Balloon Catheter's performance is established through:

• Engineering specifications and standards: For dimensional, strength, pressure, and fatigue tests.
• Biological testing standards (ISO 10993): For biocompatibility.
• Sterilization and packaging standards (ISO 11135, ISO 11607, ISTA 2A, ASTM F1980): For sterility, integrity, and shelf life.
• Simulated use in cadavers: Provides a realistic anatomical environment for evaluation, implicitly using the cadaver anatomy as "ground truth" for device interaction.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithmic device that uses training data.

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

Not applicable. As above, this is not an AI/algorithmic device requiring a training set with established ground truth.

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The Dillard Airway Dilatation System is intended to dilute strictures of the airway trees.

The Dillard Airway Dilatation System includes a balloon catheter whose working length is 25cm or 100cm, and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.

The provided text describes the Dillard Airway Dilatation System (K153484) and its claim of substantial equivalence to a predicate device. However, it does not contain information related to an AI/ML-driven device or study results with acceptance criteria.

The document is a 510(k) premarket notification for a medical device (dilatation catheter) and focuses on demonstrating substantial equivalence to a legally marketed predicate device through physical descriptions, indications for use, comparison of characteristics, and traditional performance testing.

Therefore, I cannot fulfill your request for the following reasons derived from the text:

1. No AI/ML Device: The device described, the Dillard Airway Dilatation System, is a physical medical instrument (a balloon catheter) used for dilating airway strictures. It is not an AI/ML software or system.
2. No Acceptance Criteria for AI/ML Performance: Since it's a physical device, the "acceptance criteria" and "reported device performance" are related to mechanical and biocompatibility tests (e.g., dimensional specifications, joint separation strength, balloon burst pressure, inflation/deflation times, cycle fatigue, biocompatibility), not AI/ML metrics like sensitivity, specificity, or AUC.
3. No Human Reader Study: As it's not an AI/ML device, there are no mentions of sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
4. No Standalone Algorithm Performance: The concept of "standalone performance" for an algorithm is not applicable to a physical medical device.
5. No Ground Truth for Training Set: There is no training set mentioned, as it's not a machine learning model.

The document solely focuses on demonstrating substantial equivalence of a physical medical device to a predicate device through conventional engineering and biological testing.

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The DSS Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The DSS Balloon Catheter is a flexible catheter that is intended to dilate the sinus ostia. The device is compatible with commonly used accessories including standard guide wires, guide cannulas and inflation devices. Catheter working length is from 25cm up to 140cm and is available in both over-the-wire (large diameter balloons) and rail configurations (small diameter configurations).

The distal end of the catheter includes a balloon that expands to known diameters and lengths at specific pressures. The balloon has radiopaque markers to assist with radiographic positioning. The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from either a rapid exchange style distal port just proximal to the balloon (small diameter configurations) or through the central lumen back to the proximal hub (large diameter configurations) and through the distal tip. The DSS Balloon Catheter is supplied sterile and intended for single use.

This FDA 510(k) summary for the Dillard Sinuplasty System (DSS) Balloon Catheter does not contain the detailed acceptance criteria and study information typically found in a clinical study report for device performance. This document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Indications for Use: The DSS Balloon Catheter is intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, it's specifically for dilating sinus ostia and spaces associated with the maxillary sinus.
• Fundamental scientific technology.
• Important performance specifications.
• Non-clinical performance testing: This includes dimensional verification, balloon rated burst pressure, balloon fatigue, balloon inflation and deflation, catheter joint bond strengths, and biocompatibility testing.

The document states that "No new questions of safety or effectiveness were identified during device testing," which implies that the device met internal design specifications and safety requirements as demonstrated by these tests. However, it does not provide:

• A table of acceptance criteria and reported device performance with specific numerical values. The listed performance tests are categories, not specific criteria or results.
• Clinical study details: This includes sample size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or details on ground truth establishment for either training or test sets. This device appears to have been approved based on substantial equivalence and non-clinical bench testing, not a clinical trial demonstrating specific performance metrics against clinical outcomes or expert consensus.

Therefore, for the specific questions asked, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document lists performance tests conducted (e.g., Balloon Rated Burst Pressure (RBP), Balloon Fatigue) but does not state the specific acceptance criteria (e.g., "RBP must be > X psi") or the actual reported performance values.
2. Sample sized used for the test set and the data provenance: Not applicable as no clinical test set for performance against human or clinical outcome ground truth is described. The tests mentioned are non-clinical, bench-top tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert ground truth for a clinical test set is described.
4. Adjudication method for the test set: Not applicable.
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 manual surgical 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 is not an algorithm.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established engineering specifications and physical properties of the materials and device. For example, for "Dimensional Verification," the ground truth is the engineering drawing specification.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) summary, which establishes substantial equivalence, often through bench testing and comparisons to predicate devices, rather than comprehensive clinical performance studies involving human subjects and specific acceptance criteria for diagnostic accuracy or clinical outcomes.

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