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This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.

According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.

Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.

The provided FDA 510(k) summary for the "Single-use Balloon Dilatation Catheter" (K241888) details a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than an AI/ML software performance study. Therefore, most of the requested information regarding AI/ML device acceptance criteria, human reader studies, and ground truth establishment for AI/ML models is not applicable to this document.

The document describes performance testing for a physical medical device. Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide a specific table detailing the exact quantitative acceptance criteria for each test and the corresponding measured performance values. It lists the types of tests performed.

2. Sample sizes used for the test set and data provenance:
The document states "The performance testing conducted on subject device and predicate device are listed below." and mentions "ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices". This suggests that standard device testing sample sizes were used in accordance with this guideline, but the specific sample sizes for each test are not explicitly stated in this summary.
Data provenance: This is a physical device, so "data provenance" would refer to the testing conditions and results. The tests were performed in a lab setting to verify design specifications and compliance with international standards (e.g., ISO, ASTM, USP). The country of origin for the testing is not specified, but the applicant company is Leo Medical Co., Ltd. in China. The data is prospective as it's generated through device testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This question is not applicable as this is a physical device performance study, not a study involving human reader interpretation of images or AI/ML model output requiring "ground truth" established by experts in a clinical context. The "ground truth" for these tests are the physical measurements and compliance with engineering and material standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's a physical device performance study. Adjudication methods are typically for clinical consensus on ground truth in image interpretation or diagnosis, not for engineering performance tests.

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 is not applicable. No MRMC study was performed as this is not an AI/ML-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an algorithm, but a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this physical device, the "ground truth" for the non-clinical tests is based on established engineering and material science standards, measurements, and pre-defined acceptance criteria. For example, burst pressure is measured against a standard, biocompatibility is assessed against ISO 10993, and sterility against ISO 11135.

8. The sample size for the training set:
This is not applicable. No training set was used as this is a physical device, not an AI/ML model being "trained."

9. How the ground truth for the training set was established:
This is not applicable. No training set was used.

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It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.

The 3-Stage Balloon Dilation Catheter can provide 3 different sizes and gradually increasing diameters through controlled radial expansion. The specific balloon size is printed on the label of each package and catheter. The 3-Stage Balloon Dilation Catheter is designed to pass through the working channel of the endoscope, and its guidewire cavity can accommodate a 0.035inches (0.89mm diameter) guidewire. In the package, a 0.035inches (0.89mm diameter) guidewire is pre-installed in the guidewire cavity. There is a guidewire locking device connected to the guide wire hole of the catheter. The locking device will be in the "OFF" (closed) position when it leaves the factory. Only when the switch of the locking device is in the "ON" position can it be pushed or moved forward. The guide wire is removed from the catheter. After turning the switch to the "OFF" position, the guide wire will be fixed in the catheter.

This document details the FDA's 510(k) clearance for the VedDilator™ 3-Stage Balloon Dilation Catheter. It does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, the requested information regarding acceptance criteria and performance of an AI/ML-based device cannot be extracted from this document.

The document focuses on the substantial equivalence of this medical device (a physical catheter) to a predicate device based on non-clinical performance testing and biocompatibility.

Here's why the requested information cannot be provided from this document:

• No AI/Machine Learning: The device is a physical catheter, not a software or AI-based diagnostic tool.
• No Diagnostic Performance Study: The document lists non-clinical bench testing for physical characteristics (e.g., burst pressure, maneuverability, sterility) and biocompatibility, not diagnostic performance metrics like accuracy, sensitivity, or specificity.
• No Human Reader Study: Since it's a physical device, there's no concept of human readers or MRMC studies.
• No Ground Truth Establishment: The "ground truth" in this context refers to the physical properties of the device, measured through standard engineering tests, not a clinical diagnosis established by experts.

Summary of available information (not directly addressing the prompt's request for AI/ML device performance):

• Device: VedDilator™ 3-Stage Balloon Dilation Catheter
• Purpose: To endoscopically dilate strictures of the alimentary tract.
• Study Type: Non-clinical bench testing and biocompatibility testing for substantial equivalence to a predicate device (K112994).
• No Clinical Study: Section 7 explicitly states, "No clinical study is included in this submission."
• Test Performed (Non-Clinical): Rated burst pressure test, Balloon tightness test, Connection firmness test, Maneuverability test, X-ray development performance test, Sterility test, Residual amount of ethylene oxide Test, Balloon fatigue Test, Burst Test of Guidewire, Bend Test of Guidewire, Connection Strength Test of Guidewire, Corrosion resistance Test of Guidewire.
• Biocompatibility Tests: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material mediated pyrogenicity.
• Conclusion: The device meets design specifications and demonstrates substantial equivalence to the predicate device based on these non-clinical tests.

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The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

The Reliant™ Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The Reliant™ Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 inch (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 inch (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.

The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.

This document is a 510(k) summary for the Reliant™ Multistage Dilatation Balloon Catheter, indicating that it is a medical device for endoscopically dilating strictures of the gastrointestinal tract.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several design verification tests conducted on the proposed device. For each test, it implicitly states that the device was found to be "substantially equivalent" to the predicate device, meaning it met the acceptance criteria derived from the predicate device's performance or established industry standards. The specific quantitative acceptance criteria values are not provided in this summary, but the successful completion of these tests indicates compliance.

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

The document does not specify the sample sizes used for each of the design verification tests. It also does not explicitly state the data provenance (e.g., country of origin or whether data was retrospective or prospective). However, as a 510(k) submission, the tests are typically conducted in a controlled laboratory environment by the manufacturer for regulatory purposes, implying an internal, prospective testing approach.

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

This document describes device performance testing, not clinical studies involving human or expert interpretation of data. Therefore, the concept of "ground truth" established by experts for a test set, as would be relevant in an AI/diagnostic imaging context, does not directly apply here. The "ground truth" for these engineering tests would be the established specifications and performance limits for the device components.

4. Adjudication Method

Not applicable, as this is device performance testing, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a physical medical device (a balloon catheter), not an AI/software device that would typically involve MRMC studies to assess human reader improvement with AI assistance. The document explicitly states "No clinical study is included in this submission."

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device performance tests would be based on engineering specifications, industry standards, and regulatory requirements. For example:

• Balloon Burst Pressure: The ground truth is the specified burst pressure beyond which the balloon should not fail.
• Dimensions: The ground truth is the specified dimensional tolerances of the device components.
• Sterility: The ground truth is the standard for sterility, often validated through methods like bacterial endotoxin testing and direct inoculation.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device performance evaluation and not an AI/machine learning submission, there is no "training set."

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

Not applicable, as there is no training set.

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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 Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

The Reliant™ Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The Reliant™ Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.

The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the performance tests in the typical sense of a target metric the device must achieve. Instead, it reports the measured values for the proposed device and compares them to the predicate device. The underlying acceptance criterion for these tests is that the new device should be substantially equivalent to the predicate device, meaning its performance characteristics are similar enough not to raise new questions of safety or effectiveness.

Note: For tensile strength, the comparison indicates "similar," implying that the measured values, while not identical, are considered acceptable for demonstrating substantial equivalence given the context of the device's function and intended use. For biocompatibility, the results are identical, indicating the proposed device performs the same as the predicate in these aspects.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the tensile strength tests (e.g., how many balloons were tested). For biocompatibility, the tests are typically performed on a statistically relevant number of samples according to ISO standards, but the specific number is not disclosed.
• Data Provenance: The document does not explicitly state the country of origin for the test data for the tensile strength and biocompatibility tests. Given that Micro-Tech (Nanjing) Co., Ltd. is based in China, it is highly probable the testing was conducted in China or by a contracted lab. The data is retrospective in the sense that these tests were performed on the finished device before this 510(k) submission.

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

This type of information is not applicable to this document. The "ground truth" for material property tests like tensile strength and biocompatibility is established by standardized laboratory methods and measurements, not by expert consensus or interpretation of images/clinical data. These are objective measures.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and biological material characterization tests, which do not involve such human-based adjudication.

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 is not applicable. The device is a medical catheter (a physical instrument), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant for this type of device.

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

This is not applicable. As mentioned above, the device is a physical medical instrument, not an algorithm or AI system.

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

The "ground truth" for the tests performed (tensile strength, biocompatibility) is based on:

• Standardized Laboratory Measurements: For tensile strength, the ground truth is the measured force required to break the material, determined by calibrated testing equipment and procedures.
• Standardized Biological Assay Results: For biocompatibility (cytotoxicity, sensitization, irritation), the ground truth is the observable biological response (or lack thereof) in laboratory assays, compared against established biological safety criteria (e.g., ISO 10993 series standards).

8. The sample size for the training set

This is not applicable. The concept of a "training set" (used for machine learning or AI algorithms) does not apply to the development or testing of this physical medical device. Device development involves engineering design, material selection, and physical testing, not algorithm training.

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

This is not applicable for the same reasons as point 8.

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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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The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.

Pilling® Esophageal Bougies are weighted, cylindrical instruments used for the dilation of the larynx and esophagus. They are designed to be reusable and resterilized by the user. Made from silicone elastomer and filled with tungsten, the bougies are marketed in French sizes 20 to 60. Pilling® Bougies have two tip styles; the Maloney bougie has a long tapered tip and the Hurst has a rounded tip. Both tips are impregnated with radio-opaque material (barium sulfate) and contain calibration marks along the tubing. By inserting the bougie through the patient's mouth and down the patient's esophagus, a clinician can mechanically push a blockage out of the esophagus or can mechanically dilate a stricture in the esophagus.

This document describes the performance testing for the Pilling® Esophageal Bougies, focusing on demonstrating substantial equivalence to a predicate device rather than a standalone AI device study.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not directly applicable to an AI device:

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

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

• Sample size: 30 samples of the Pilling® Esophageal Bougies and 30 samples of the predicate Medovations® M-Flex™ Esophageal Bougies were tested.
• Data provenance: Not explicitly stated, but based on the context of 'bench testing' and 'Teleflex has performed', it is implied to be prospective data generated by the manufacturer for the purpose of this submission. The "country of origin of the data" is not specified but would typically be the location of the manufacturing and testing facility.

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

This information is not applicable. The study described is a bench test evaluating the physical properties (tensile strength) of mechanical devices, not a study involving medical images or clinical data requiring expert human interpretation for ground truth. The "ground truth" here is a predefined engineering specification (10 lbs tensile strength).

4. Adjudication method for the test set

This information is not applicable. As a bench test with objective physical measurements, there is no need for expert adjudication. The results are quantitative and directly measured against the acceptance criteria.

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. This submission concerns a physical medical device (esophageal bougies) and is not an AI-powered diagnostic or therapeutic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This information is not applicable. The device is a mechanical tool, not an algorithm or AI system.

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

The "ground truth" for this study is a predefined engineering specification/acceptance criterion: a minimum tensile strength of 10 lbs. This is a technical standard rather than a medical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI device or a machine learning model.

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

This information is not applicable. As there is no AI or machine learning involved, there is no training set or ground truth establishment method for it.

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The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

The EsoFLIP® balloon dilation catheter is a modification of the predicate Crospon EndoFLIP® catheters. The EsoFLIP® is a small catheter with an inflatable balloon which is inserted into the gastro-esophageal junction of a patient with Achalasia. It is connected to the EndoFLIP® controller system (K I20997) and the catherer is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The EsoFLIP® catheter is inserted by the clinician. The proposed balloon dilation catheter, EsoFLIP®, can also make diameter measurements electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system. K 120997.

This document is a 510(k) Premarket Notification for the EsoFLIP® Balloon Dilation Catheter. It outlines the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for each performance metric with specific thresholds. Instead, it states that "The results demonstrate that the EsoFLIP® has met the performance specifications." and that the device is "substantially equivalent" to predicate devices. The performance data provided is primarily a comparison to the predicate device's specifications.

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The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label. It is designed to be used through an endoscope having a 2.8mm or larger working channel. A stainless steel core wire extends through the entire length of the shaft. The wire is in tension within the balloon, which facilitates the removal of the catheter from the endoscope following balloon dilatation. The proposed device incorporates a minor material formulation change for the flexible tip of the device.

The provided text describes a Special 510(k) Premarket Notification for the CRE™ Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a predicate device after a minor material formulation change. This type of submission generally relies on non-clinical data (e.g., bench testing, biocompatibility) rather than extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.

Therefore, many of the requested categories (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific submission. The focus is on demonstrating that the revised device performs similarly to the predicate device in terms of safety and basic function, not on demonstrating a new clinical performance claim or diagnostic accuracy.

Here's a breakdown based on the information provided and what is typical for a Special 510(k):

Acceptance Criteria and Device Performance

Study Details (Not Applicable/Not Provided for this Type of Submission)

This submission is a Special 510(k) for a minor change, which primarily focuses on bench testing and comparison to an already cleared predicate. Therefore, detailed clinical study information as requested is not available in this document.

1. Sample size used for the test set and the data provenance: Not applicable for a Special 510(k focused on material change and bench testing. No clinical test set details are provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as part of this type of submission.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
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 medical device (a balloon dilatation catheter), not an AI/imaging diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is compliance with engineering specifications and biocompatibility standards.
7. The sample size for the training set: Not applicable. This device is a mechanical medical device, not an AI/machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study and Conclusion from the Document:

The "study" described here is primarily a series of pre-clinical tests (biocompatibility and in-vitro functional/mechanical testing) and a design comparison to the predicate device.

• Study Goal: To demonstrate that the proposed CRE™ Balloon Dilatation Catheter with a minor material formulation change to its flexible tip is substantially equivalent in terms of safety and effectiveness to the predicate CRE™ Balloon Dilatation Catheter (K971320).
• Methods:
  • Biocompatibility Testing: Conducted according to AAMI/ANSVISO 10993-1: 2009, including Cytotoxicity, Sensitization, and Intracutaneous Reactivity (Irritation).
  • In-vitro Testing: Performed on components, subassemblies, and/or full devices to ensure they met required specifications for chemical analysis, biocompatibility, and tensile strength (likely referring to mechanical and material integrity tests).
  • Design Comparison: The proposed device's design and manufacturing processes are stated to be identical to the predicate, with the exception of the minor material formulation change.
• Results/Conclusion: Boston Scientific Corporation demonstrated that the proposed device, with its minor modifications, is substantially equivalent to the predicate device. This conclusion was based on the fulfillment of biocompatibility standards and in-vitro functional testing, coupled with the assertion of identical design and manufacturing except for the specified material change. The FDA's letter (K122924) confirms this determination of substantial equivalence.

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The CRE™ Wireguided Balloon Dilatation Catheter is indicated for use 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.

The CRE™ Wireguided Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The CRETM Wireguided Balloon Dilatation Catheter is designed to pass through a 2,8mm or greater working channel of an endoscope and a 3.2 or 4.2 mm (depending on the balloon) or greater working channel of a duodenoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter.

A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.

Here's an analysis of the provided text regarding the CRE Dilatation Balloon, focusing on the acceptance criteria and the study used to demonstrate its performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a sample size for a test set involving the new CRE™ Wireguided Balloon Dilatation Catheter. The primary performance demonstration relies on in-vitro testing and a clinical literature search.
• Data Provenance:
  • In-vitro testing: Performed internally by Boston Scientific Corporation. No country of origin is specified, but it can be inferred as originating from the manufacturer's own labs. This is typically prospective in nature for a new device's engineering verification.
  • Clinical Literature Search: This implies the use of existing published data from various sources (not specified). This would be retrospective data from prior studies on similar devices or the predicate device itself.

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

• Not applicable. The document does not describe a clinical study where a "test set" with ground truth established by experts was used for the new device. The clinical literature review likely synthesized findings from multiple studies, where individual studies might have involved expert assessments, but this is not broken down here. For the in-vitro testing, "ground truth" would be the engineering specifications and performance metrics.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical "test set" requiring expert adjudication is described for the new device itself beyond the literature review, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not performed for this 510(k) submission. The document relies on in-vitro testing and a clinical literature review for performance data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a medical instrument (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant here. The device's performance is inherently tied to its physical interaction and use by a human clinician.

7. The Type of Ground Truth Used

• For the in-vitro testing: The ground truth would be defined by engineering specifications and performance criteria established prior to testing.
• For the clinical literature search: The "ground truth" is inferred from the collective findings and conclusions of the peer-reviewed scientific literature regarding the safety and effectiveness of similar dilatation catheters. This most closely aligns with expert consensus or outcomes data reported in those studies.

8. The Sample Size for the Training Set

• Not applicable. This 510(k) pertains to a medical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As this is not an AI/ML algorithm, there is no "training set" or corresponding ground truth establishment process to describe.

Summary of Device Performance Study:

The Boston Scientific CRE™ Wireguided Balloon Dilatation Catheter's performance demonstration for 510(k) clearance relied on two primary pillars:

1. In-vitro testing: This involved laboratory tests to ensure the device components and assemblies met predefined engineering specifications. The specific tests or their results are not detailed, but the document states they "met the required specifications." This type of testing is fundamental for demonstrating the physical integrity and functional performance of a medical device.
2. Clinical Literature Search: Instead of conducting new clinical trials, the manufacturer performed a literature review. This review compiled existing data and studies on similar or predicate devices to support the safety and effectiveness of balloon dilatation catheters for the specified indications (alimentary tract strictures, Sphincter of Oddi dilatation). This approach is common for 510(k) submissions, particularly when a new device is substantially equivalent to a well-established predicate.

The crucial aspect of this submission, explicitly stated, is that the proposed device is identical in design, materials, and manufacturing processes to a previously cleared predicate device (K110833). This "substantial equivalence" is the cornerstone of its clearance without extensive new clinical data.

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