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The balloon dilatation catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
• balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

The Apollo Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from 2.0mm to 5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0- 4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The minimally compliant balloon material will allow high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube of nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm in length located on the proximal shaft, indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes a 510(k) summary for the Apollo Balloon Dilatation Catheter, a medical device. The information details the device's technical characteristics and performance data, but it does not describe a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop performance study.

Instead, the performance data section summarizes in vitro bench tests for the physical characteristics of the catheter. This is a very different type of study than what would be described for an AI-powered diagnostic device.

Therefore, many of the requested details, such as the sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details, are not applicable to this document as it concerns an entirely different type of medical device evaluation.

However, I can extract the acceptance criteria and the reported device performance for the physical properties of the catheter as described.

Here's the information based on the provided text, while acknowledging that it does not correspond to an AI performance study:

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

Regarding the remaining points, they are not applicable because this document describes the evaluation of a physical medical device (catheter) through bench testing, not an AI/software-based diagnostic system.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" refers to physical samples of the catheter for in vitro bench testing, not a dataset of patient information. The document does not specify the number of catheters tested for each performance characteristic.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be engineering specifications and measurements, verified by qualified engineers or lab personnel.
4. Adjudication method: Not applicable. Bench testing relies on objective measurements against engineering specifications.
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 is for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical characteristics, the ground truth would be established engineering specifications, material properties, and physical measurements (e.g., precise dimensions, burst pressures, bond strengths).
8. The sample size for the training set: Not applicable. This device is evaluated via physical bench testing, not machine learning model training.
9. How the ground truth for the training set was established: Not applicable.

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The Apollo Balloon Dilatation Catheter is indicated for:
1.The balloon dilatation catheted for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
2.Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
3.Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)
Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

The Apollo Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from 2.0mm to 5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0-4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The minimally compliant balloon material will allow high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube of nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm in length located on the proximal shaft, indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The BrosMed Medical Co., Ltd.'s Apollo Balloon Dilatation Catheter (K133852) underwent extensive testing to demonstrate its substantial equivalence to predicate devices. The study performed primarily focused on in vitro performance and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the test results "met all acceptance criteria" and "were similar to predicate devices," but specific quantitative acceptance criteria or detailed performance data for each test are not provided in this summary.

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

The document mentions "Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents." However, it does not specify the sample size for the test set used for the in vitro performance tests or the biocompatibility tests.

The data provenance is not explicitly stated beyond being "Bench testing." It is implied to be laboratory-based (in vitro) and is not described as retrospective or prospective clinical data. The manufacturer is BrosMed Medical Co., Ltd. from Dongguan, Guangdong, China.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the summary describes in vitro and biocompatibility testing, not studies involving human interpretation or clinical ground truth assessments by experts.

4. Adjudication Method for the Test Set:

This information is not applicable as the summary describes in vitro and biocompatibility testing, not studies involving human interpretation where adjudication would be required.

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

An MRMC comparative effectiveness study was not performed, or at least not described in this 510(k) summary. The study focuses on demonstrating substantial equivalence through in vitro performance and biocompatibility, not on a direct comparison of human readers' performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable as the device is a physical medical device (balloon dilatation catheter), not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's evaluation was based on engineering specifications, material science standards, and established biocompatibility testing protocols and limits. For example, the rated burst pressure of the balloon is a direct engineering specification. Biocompatibility tests rely on recognized standards for assessing material safety.

8. Sample Size for the Training Set:

This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning.

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

This information is not applicable as the device is a physical medical device and does not involve a "training set" or a ground truth established for such a set.

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