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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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The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.

The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states "The Balloon Dilatation Catheter meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135)". For the other items listed under "Following tests were conducted in our non-clinical bench test," the document states "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This implies that the acceptance criterion for these tests was to meet their respective design specifications.

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

The document does not explicitly state the sample sizes used for the non-clinical bench tests. It also does not provide information on the provenance of data for these tests (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a Balloon Dilatation Catheter, and the assessment relies on engineering and biological performance standards, not expert interpretation of medical images or clinical outcomes that typically require expert ground truth establishment.

4. Adjudication Method

Not applicable. As noted above, this submission focuses on bench testing against established standards and design specifications, not on subjective clinical assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No Clinical test is included in this submission." Therefore, no MRMC study was conducted.

6. Standalone Performance Study

Yes, a standalone performance study in the form of non-clinical bench testing was conducted to evaluate the device against its design specifications and relevant medical device standards. The "Performance Data" section details the various aspects tested (e.g., head tip, connect strength, leakage, balloon fatigue, etc.).

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation was based on:

• Design specifications: The device's performance was compared against its own pre-defined engineering and functional requirements.
• Relevant medical device standards: Specifically, ISO 10993 for biocompatibility and ISO 11135 for sterility. While not explicitly named for other tests, it's implied that recognized engineering and performance standards would be followed.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and its performance is evaluated through bench testing and conformance to standards, not through machine learning models that require training sets.

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

Not applicable, as there is no machine learning training set for this device.

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