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The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.

This is a 510(k) premarket notification for a medical device called "Breezeway II," a catheter introducer. The document details the device's characteristics and how it compares to a predicate device ("Adelante Breezeway Delivery Sheath," K122958) to demonstrate substantial equivalence, rather than a study proving the device meets an acceptance criteria for an AI/ML powered device. Therefore, it is impossible to provide the requested information.

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The Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (ages 2 years old and above) and adult patients in the home. It is not intended for use with Pentamidine.

Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer that delivers aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. It is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. They are identical in purpose, function, core technology and method of operation.

Breeze nebulizer (NBR-101) is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available and to turn off automatically. The open button is made of soft materials and gives off an ice blue light, coupled with an overall elegant white exterior.

Breeze Nebulizer (NBR-101) is battery powered, 4 "AAA" and the dimensions is 58(W) X 145(H) X 70(D). The medication container capacity is 8ml maximum and the residual volume is approximately 0.1ml.

This document describes the 510(k) premarket notification for the Breeze Nebulizer (NBR-101), specifically focusing on its substantial equivalence to a predicate device rather than a study demonstrating it meets specific clinical performance acceptance criteria. As such, information regarding AI, ground truth, sample sizes for training/test sets, or expert involvement in establishing ground truth is not applicable.

The core of the submission relies on non-clinical testing to demonstrate safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various standards and regulations applied for different testing items. The reported performance is generally stated as meeting the requirements of these standards. Specific numerical acceptance criteria or detailed performance metrics are not provided in this summary.

The document also provides a comparative table of characteristics between the proposed device and the predicate device, highlighting their similarities and differences. While this is not "acceptance criteria" in the traditional sense, it demonstrates how the device's characteristics are compared against a legally marketed device.

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

The document does not specify a "test set" in the context of a clinical performance study. The studies mentioned are non-clinical (bench tests, safety tests), and the sample size for these engineering and regulatory compliance tests is not provided in this summary. The data provenance is from digiO2 International Co., Ltd. in New Taipei City, Taiwan, performing internal non-clinical testing. These are assumed to be prospective tests conducted for the purpose of the 510(k) submission.

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

Not applicable. This is a submission for a medical device that relies on non-clinical engineering and regulatory compliance testing rather than clinical data or expert-derived ground truth.

4. Adjudication method for the test set

Not applicable.

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 not an AI-powered diagnostic tool, and no MRMC study was performed.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" implicitly refers to the specified performance parameters and safety limits defined by the referenced international standards (e.g., IEC 60601-1, ISO 10993, EN 13544-1). Compliance with these standards serves as the benchmark.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable.

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The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric Transport Chair is controlled, steered and operated completely by a trained caregiver.

The BREEZ Electric Transport Chair is a motorized device that allows caregivers to move patients up to 750 pounds in weight. The device has self-contained batteries to provide power that can be recharged by an on-board battery charger that can be plugged into a 120/240 VAC outlet when the device is not in use. The device is supported by four wheels whereby the front wheels provide the motive force to propel the unit in either the forward or reverse direction. The caregiver directs the movement of the device using a steering handlebar and various hand-operated controls attached to the rear of the device.

The provided text describes a 510(k) premarket notification for the BREEZ 1025 Electric Transport Chair. Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of typical clinical or AI medical device studies (i.e., a dataset of patient cases used to evaluate an algorithm's performance). Instead, the testing appears to be engineering and product performance testing conducted on the device itself.

• Sample Size: The document does not explicitly state the number of BREEZ Electric Transport Chairs tested. It refers to "the BREEZ Electric Transport Chair" (singular), but this typically implies multiple units or systematic testing of a representative unit(s) to verify consistency, even if not explicitly stated as a "sample size."
• Data Provenance: This is not applicable in the context of clinical data provenance. The tests were conducted on the physical device by the manufacturer (Electro Kinetic Technologies, LLC) or a contracted testing facility. It is prospective in the sense that the device was manufactured and then tested to these standards. The country of origin of the data would be the location where these engineering and performance tests were performed (likely the US, given the submission location).

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

This is not applicable to the type of testing described. "Ground truth" in the context of medical efficacy or diagnostic accuracy (e.g., for AI) is established by expert review, pathology, or outcomes. The acceptance criteria here relate to engineering performance and safety standards, where the "ground truth" is adherence to the specified technical requirements of the standards (e.g., a specific level of radiated emissions, a given static load capacity). The experts involved would be engineers or technicians with expertise in conducting and interpreting these specific tests.

4. Adjudication Method for the Test Set

This is not applicable for the type of testing described. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations of clinical data. For engineering standards, the outcome is typically a pass/fail against a defined technical specification.

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

No MRMC comparative effectiveness study was mentioned. This type of study is relevant for AI-powered diagnostic or assistive devices where human-in-the-loop performance is being evaluated. The BREEZ Electric Transport Chair is a purely mechanical/electrical transport device, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was mentioned. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance criteria is defined by the technical specifications and performance requirements set forth in the voluntary standards referenced (CISPR 11, EN61000 series, RESNA WC-1: 2009, RESNA WC-2: 2009, and California Flammability Regulation Bulletin 117, Section E). The device's performance was compared directly against these established engineering and safety benchmarks.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This device does not employ machine learning or AI algorithms that require a training set.

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

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

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The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons. The Breeze is also suite for the use of elderly persons and physically disabled persons.

Breeze C, 3&4 wheels Scooter

This is an FDA 510(k) clearance letter for a medical device (Breeze C, 3&4 wheels Scooter), not a study report or clinical trial
document. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study
details, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather
than proving performance against specific acceptance criteria through a clinical study as would be detailed in a separate
performance testing report or clinical trial submission.

Therefore, I cannot extract the requested information from the provided text.

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The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suite for the use of elderly persons and physically disabled persons.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Breeze," a motorized three-wheeled vehicle (scooter) manufactured by Afikim Electric Vehicles. This letter grants clearance for the device based on its substantial equivalence to a legally marketed predicate device, but it does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.

The document states:

• Device Name: Breeze
• Regulation Number: 21 CFR 890.3800
• Regulation Name: Motorized three-wheeled vehicle
• Regulatory Class: II
• Product Code: INI
• Indications for Use: "The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suitable for the use of elderly persons and physically disabled persons."

Since this document is simply an FDA clearance letter, it does not include the detailed technical study information you are requesting. Such information would typically be found in the 510(k) submission itself, which is a much more extensive document. Therefore, I cannot provide the requested details about acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications based on the provided text.

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These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.

The Breeze Digital Inflation Device, like its predicates, the Morse Balloon Inflation Device and the Merit Monarch Inflation Syringe is a Balloon Inflation Syringe. These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.

A Balloon angioplasty catheter provides a fluid column which communicates pressure inside the balloon to the digital pressure gage. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The analog signal from the sensor is then displayed on the liquid crystal display of the gage. The manual timer operates independently of the above mentioned pressure gage. The timer is started and stopped by depressing the Start/Stop button and can be reset to 00m00s by depressing the Reset Button.

The Breeze Digital Inflation Device shares a common design with the Morse Balloon Inflation Device in that they both are comprised of a clear syringe barrel with an attached pressure gauge, a threaded plunger and a latching mechanism that operate in tandem to generate and control balloon inflation pressure. The Breeze Digital Inflation Device has in common with the Merit Monarch Inflation Syringe, a digital pressure gauge.

This 510(k) summary describes a medical device, the Breeze™ Digital Balloon Inflation Device, but it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert involvement.

The document focuses on:

• Device Description: What the device is and its intended use (balloon inflation/deflation and pressure measurement during angioplasty).
• Comparison to Predicates: How it's similar to and different from previously cleared devices (Morse Balloon Inflation Device, Merit Monarch Inflation Syringe).
• Material Equivalence: Mentions biocompatibility testing on predicate devices and states the fluid path material is identical.
• Key Design Differences: Highlights changes like the latching mechanism, digital vs. analog gauge, O-ring vs. stopper, increased pressure rating, and increased syringe volume.
• Digital Gauge Specifics: Notes that the Breeze device's digital gauge uses non-software driven solid-state circuitry, unlike the Merit Monarch's software-driven microprocessor.
• Performance Testing (Limited): It mentions "non-clinical performance testing" for gauge pressure rating and accuracy, and states "The results of the tests do support the claimed pressure and accuracy."

Here's why I cannot fulfill your request based on the provided text:

1. Acceptance Criteria Table: The document states the claimed pressure and accuracy (0-30 ATM ± 2% of full scale) and that the test results support this claim. However, it does not provide a table outlining the acceptance criteria (e.g., what would be considered unacceptable performance within that tolerance) and the "reported device performance" beyond a general statement of compliance.
2. Study Details (Sample Size, Data Provenance, # Experts, Adjudication, MRMC, Standalone): This document is a 510(k) summary, which is a high-level overview. It does not include the detailed methodology of the performance testing. Therefore, it lacks:
   • Sample size for the test set.
   • Data provenance (country, retrospective/prospective).
   • Number or qualifications of experts.
   • Adjudication methods.
   • Any mention of MRMC comparative effectiveness studies or their results.
   • Clarification on whether the performance testing was "standalone" in the way you're asking (i.e., algorithm only without human-in-the-loop performance, though for a manual device, this specific question might not fully apply).
3. Ground Truth, Training Set: These concepts are typically relevant for AI/ML devices or diagnostic accuracy studies. For a mechanical device like a balloon inflation device, "ground truth" often refers to a verified standard (e.g., a calibrated pressure transducer). While it states non-clinical performance testing was done, it does not specify the ground truth used (e.g., what type of calibrated reference device was used), nor does it mention any "training set," as this device does not appear to involve machine learning or AI.

In summary, the provided text is insufficient to answer your comprehensive questions about acceptance criteria and study details. It confirms performance testing was done for pressure accuracy, but without the granular details you're requesting.

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