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The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.

The subject dilation balloon consists of an PET balloon attached to a 75 cm that is secured to a white Pebax Y junction with two extension lines leading with a wire guide hub and an inflation hub. The catheter has four black ink markers on the catheter.

The dilation balloon is composed of PET, with a patient contacting length of 8 cm which can be inflated to a single size of 30 mm or 35 mm in diameter. The balloon has a 1.16" long tip made of white Neuthane. Three tantalum radiopaque bands are placed underneath the balloon to assist in fluoroscopic visualization of the balloon.

The provided text describes a medical device, the Wilson-Cook Achalasia Balloon, and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study involving AI or human readers.

Therefore, I cannot provide the requested information in the format of acceptance criteria, device performance, sample sizes, expert qualifications, or MRMC studies, as these details are completely absent from the given FDA letter and associated summary.

The document focuses on the regulatory clearance process for a traditional medical device (a balloon dilator) and its comparison to a predicate device. The information provided is primarily about:

• Device Name: Wilson-Cook Achalasia Balloon
• Intended Use: To dilate the lower esophageal sphincter in patients with Achalasia (adult use only).
• Predicate Device: Rigiflex II Single-Use Achalasia Balloon Dilator (K050232)
• Comparison: The subject device is considered "substantially equivalent" to the predicate, with minor differences outlined (materials, patient contacting length, dimensions, non-sterile packaging, and higher maximum inflation pressure). These differences are stated not to raise new questions of safety or effectiveness.
• Non-Clinical Testing: A list of performance tests conducted (e.g., Balloon Diameter and Length, Pressure Verification, Distensibility, Tensile Testing, Dimensional Verification, Functional Testing, Shelf Life Testing, Biocompatibility). These tests demonstrate that the device performs as intended, but specific acceptance criteria or quantitative results are not detailed in this summary.

In summary, the provided text describes the regulatory clearance of a physical medical device and its non-clinical testing for performance and equivalence to a predicate, not an AI/ML-driven device or study with the characteristics requested in your prompt.

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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.

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 lists "Bench Testing" reports (e.g., DHF_1343, DHF_1290, DHF_1296, etc.) which indicate non-clinical lab-based testing. However, the specific sample sizes used for these tests are not provided within this document. The provenance of this data is from the manufacturer, Crospon Ltd. in Ireland, as indicated by the company's address. The testing is non-clinical, so "retrospective or prospective" does not directly apply in the same way it would for clinical data, though it represents new testing performed for this submission.

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 document details bench testing (non-clinical), not clinical trials involving human subjects or expert assessment of medical images for ground truth. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable and not provided in this submission.

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

As this document describes bench testing, there is no adjudication method for a test set involving human interpretation of results. The "ground truth" for the bench tests would have been established by the test protocols and measurement instruments.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. This submission is for a medical device (catheter) and focuses on its physical and functional equivalence to predicate devices through non-clinical testing.

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

This document describes a physical medical device (catheter) with a measurement function described as "electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system." While there is a "measurement" aspect, it's not an AI algorithm in the typical sense that would have a standalone performance evaluated for "algorithm only" against human-in-the-loop. The performance listed (range, resolution, accuracy) refers to the device's ability to measure diameter, which is a standalone function of the device and its associated controller.

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

For the non-clinical bench testing, the "ground truth" would be established by controlled experimental conditions, metrology standards, and validated measurement equipment. For example, in "Balloon Compliance Tests," the ground truth for displacement or pressure would come from calibrated sensors and known physical properties. There is no expert consensus, pathology, or outcomes data relevant to these non-clinical tests.

8. The sample size for the training set

This document describes a medical device, not an AI algorithm that requires a "training set." Therefore, this information is not applicable and not provided.

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

As there is no training set for an AI algorithm, this information is not applicable and not provided.

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The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

The Rigiflex™ II Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end.

I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Rigiflex™ II Single-Use Achalasia Balloon Dilator) and confirms its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, details of a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, or other elements you've requested.

The section "PERFORMANCE DATA" briefly mentions that "functional testing support a determination of substantial equivalence," but it does not elaborate on the data itself, the criteria it met, or the specifics of the study design. It also refers to a general FDA guidance document, not a report of specific study results for this device.

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