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The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Balloon Inflation System is mainly used to treat vertebral compression fractures caused by osteoporosis. Puncture needles or dilators are used to establish working channels, then balloon catheters are placed along the working channels and inflation device connect to balloon catheter and control it expansion to lift the upper and lower endplates of the vertebral body, restore the height of the vertebral body, and form bone cement filling cavities.

This is a 510(k) Premarket Notification for a Balloon Inflation System, which is a medical device, and therefore the document does not contain information about acceptance criteria and study designs typically associated with AI/ML-driven software devices. The provided text is a summary of documentation for a physical medical device.

Specifically, the document addresses:

• Device Name: Balloon Inflation System
• Regulation Number/Name: 21 CFR 888.3027, Polymethylmethacrylate (PMMA) Bone Cement
• Regulatory Class: Class II
• Product Code: NDN
• Intended Use: For the reduction of fractures and/or creation of a void in cancellous bone in the spine (percutaneous vertebral augmentation, e.g., kyphoplasty), to be used with cleared spinal PMMA bone cements.

The acceptance criteria and supporting studies for this type of device focus on non-clinical bench testing to demonstrate performance, safety, and substantial equivalence to a predicate device, rather than AI/ML performance metrics.

Here's a breakdown of the information that is present, relevant to a physical medical device, contrasted with the AI/ML-specific questions you asked:

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

The document provides a summary of non-clinical tests that were performed and states that the "test results met the preset criteria." However, it does not provide a detailed table of specific acceptance criteria values (e.g., "burst pressure > X psi") or the exact reported performance values. It only generically states that results met criteria.

Here's what's described:

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

For the non-clinical tests mentioned, sample sizes are not specified. Data provenance is implied to be laboratory testing conducted by or for Ningbo HicRen Biotechnology Co., Ltd. There is no mention of human subject data (retrospective or prospective) as this is not an AI/ML device.

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

This is not applicable to a physical medical device submission. "Ground truth" in this context refers to engineering specifications and performance standards established through industry standards (like ISO) and regulatory requirements.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human image interpretations, which is not relevant here.

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 an AI/ML device-specific question.

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

Not applicable. This is an AI/ML device-specific question.

7. The type of ground truth used

For this physical device, the "ground truth" is based on engineering specifications, established international standards (e.g., ISO 11138-2, ISO 10993 series), and pre-set internal criteria for performance and safety. There is no pathology or outcomes data used for "ground truth" in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set or corresponding ground truth for an AI/ML model for this physical device.

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The inflation system is recommended for use during esophageal, pyloric and colonic balloon dilatation to inflate and deflate balloon dilators and to monitor the pressure within the balloon.

The Bard" Inflation System is a disposable, two-piece, plastic 60cc syringe with a cantilevered inflation/deflation lock design and a manometer that is mounted on the distal tip of the syringe barrel.

The provided text is a 510(k) summary for the Bard® Balloon Inflation System from 1999. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria.

The document states: "Safe and effective in vivo use has been demonstrated with the Bard Balloon Inflation System since its initial commercialization in 1991." and "Comparative bench testing has been evaluated and supports the use of a GI inflation device." However, no specific performance metrics, acceptance criteria, or study details are provided in this regulatory submission.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with many points marked as "Not specified in the provided text":

Acceptance Criteria and Device Performance

Since specific acceptance criteria and detailed performance data are not explicitly stated in the provided 510(k) summary, the table below reflects the general claims and the type of assessment mentioned.

1. A table of acceptance criteria and the reported device performance:
See the table above. The document primarily relies on the device's prior commercialization history and comparative bench testing to assert safety and effectiveness and substantial equivalence. Specific quantitative acceptance criteria (e.g., pressure accuracy within X mmHg, inflation time within Y seconds) are not detailed.

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

• Sample Size: Not specified for the comparative bench testing or the "in vivo use" claim.
• Data Provenance: Not specified. It mentions prior commercialization since 1991, which implies retrospective real-world use data, but no specifics are given. The "comparative bench testing" is implied to be internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified. The document refers to "Accepted scientific methods" for bench testing and "in vivo use" but does not detail expert involvement in evaluating this for the 510(k) submission.

4. Adjudication method for the test set:
Not specified.

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 device is a manual medical instrument (a balloon inflation system), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device requiring human operation. The "performance data" refers to the device's mechanical function, not an algorithm's.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "safe and effective in vivo use," it implies outcomes data from its commercialization history. For the "comparative bench testing," the ground truth would be based on engineering specifications and measurements of the device's mechanical performance in comparison to predicate devices, but the specifics are not provided.

8. The sample size for the training set:
Not applicable. This is a hardware device, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable.

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