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The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device.

Like the predicate, the EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm.

The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

The provided document K180086 describes the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter and its substantial equivalence to predicate devices, rather than a clinical study establishing specific performance criteria against predefined metrics.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance with numerical values, as these are not part of the substantial equivalence claim.
• Sample size used for the test set or data provenance, as this was not a clinical effectiveness study.
• Number of experts, their qualifications, or adjudication methods for ground truth, as ground truth establishment for a diagnostic output is not relevant here.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance, as AI is not concerned in this submission.
• Information on a standalone algorithm performance, as AI is not concerned in this submission.
• Type of ground truth used (pathology, outcomes data, etc.), as this is a device clearance based on equivalence, not a diagnostic accuracy study.
• Sample size for the training set or how ground truth was established for it, as this is irrelevant for this type of device submission.

However, based on the provided text, I can infer the "acceptance criteria" and how the device (Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter) was shown to "meet" these criteria in the context of a 510(k) submission:

1. Acceptance Criteria (Implied for 510(k) Substantial Equivalence):

For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device:

• Has the same intended use as the predicate device.
• Has the same technological characteristics as the predicate device, or that differences do not raise new questions of safety or effectiveness.

In this specific case, for the "minor process changes" that resulted in "rounders to the balloon; enhancing balloon visualization," the acceptance criteria for these particular changes would have been that the repeated performance tests demonstrated the device still met or exceeded the established specifications and safety profiles.

Reported Device Performance (against equivalence, not quantitative clinical metrics):

The submission asserts that the proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is "substantially equivalent" to the predicate devices and "presents no new questions of safety or effectiveness."

This is supported by:

• Identical intended use to a predicate Boston Scientific device (K112994).
• Identical design and scientific technology to its own predicate (K143609).
• No material changes from the predicate (K143609).
• Successful completion of a battery of performance tests following minor process changes.

2. Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is the Traditional 510(k) Notification (K180086) document itself, which compares the new device to predicate devices and provides results from non-clinical performance testing.

Relevant information from the document:

• Sample size used for the test set and the data provenance: Not explicitly stated as this is a technical verification, not a clinical study. The performance tests would have been conducted on a sufficient number of device samples to ensure design verification and validation, according to internal company procedures and relevant standards.
• Number of experts and qualifications, and adjudication method: Not applicable as this is a device clearance based on engineering and design comparison, not subjective expert assessment of diagnostic output.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: No, this is not an AI/diagnostic imaging device, and such a study was not performed or required for this type of 510(k) submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the performance tests, the "ground truth" would be the established engineering specifications and safety limits for the device. For example, for "Balloon Burst Testing," the ground truth is a specific pressure at which the balloon must not burst, or a specific range. For "Dimensional Measurements," the ground truth is the specified dimensions.
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Specific Performance Tests Conducted (following minor process changes leading to improved balloon visualization):

The manufacturer conducted the following performance tests to demonstrate continued safety and effectiveness after minor process changes:

• Visual Inspection
• Dimensional Measurements
• Tensile Testing
• Fatigue Testing
• Luer Gauging Test
• Balloon Working Length
• Tip Stiffness Testing
• Compliance Testing
• Balloon Burst Testing
• Balloon Insertion Force Testing
• Balloon Retrieval Force Testing
• Balloon Friction Testing
• Balloon Deflation Testing
• Balloon Endoscope Compatibility Testing

The successful completion of these tests, along with the detailed comparison tables showing similarities in design features, intended use, and technological characteristics to the predicate devices, collectively serve as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicates.

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The EZDilate 3-Stage Balloon Dilatation Catheters are in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of Oddi with or without prior sphincterotomy.

The EZDilate 3-Stage Balloon Dilatation Catheter consists of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device. The EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm. The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

The provided text describes a 510(k) premarket notification for a medical device, the EZDilate 3-Stage Balloon Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing new acceptance criteria through extensive clinical studies. Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number/qualifications of experts for ground truth, MRMC studies, standalone performance, adjudication methods) is not typically part of a 510(k) submission for this type of device and is not present in the provided document.

The "acceptance criteria" for a 510(k) are primarily demonstrating that the new device performs as intended and is as safe and effective as its predicate. The "study that proves the device meets the acceptance criteria" refers to the engineering and bench testing performed to show the device's functional integrity and similarity to the predicate.

Here's an attempt to answer your questions based on the available information, with explanations where information is not applicable or provided:

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

For a 510(k) relating to a balloon dilatation catheter, "acceptance criteria" are essentially the performance specifications derived from the device's design and intended use, and often benchmarked against its predicate. "Reported device performance" comes from bench testing. The document lists the types of tests performed.

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: Not specified in the document. For bench testing of physical devices, sample sizes are typically determined by statistical methods for specific tests but are not explicitly reported in this summary.
• Data Provenance: The study described is entirely in-vitro bench testing of the device's physical and functional properties, performed by the manufacturer/contract manufacturer. There is no patient data involved (retrospective or prospective). The location of the testing laboratories is not specified beyond the manufacturer's location in the USA.

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. "Ground truth" in the context of device performance in a 510(k) for this type of device is established through engineering specifications, material properties, and comparison to the predicate device's known performance characteristics. Expert panels for diagnostic accuracy or clinical outcomes are not part of this type of submission.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or experts. This submission is based on bench testing.

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. MRMC studies are typically for diagnostic AI-powered devices to assess how the AI impacts human reader performance. The EZDilate is a physical medical device (catheter) and does not involve AI assistance or human readers in the context of diagnostic interpretation.

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

• Not applicable. This device is not an algorithm. "Standalone performance" refers to the performance of a diagnostic algorithm without human intervention, which is not relevant here.

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

• For this device, the "ground truth" for the bench testing is defined by engineering specifications, material standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate device (Boston Scientific CRE Dilatation Balloon K112994). The tests confirm that the EZDilate catheter meets these predefined physical and functional benchmarks.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for physical medical device submissions like this. Training sets are relevant for machine learning algorithms.

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

• Not applicable, as there is no training set.

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