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OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:

• 1. Alveolar ridge augmentation and reconstruction,
• 2. Alveolar ridge preservation consequent to tooth extractions,
• 3. Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
• 4. In intra bony defects around teeth,
• 5. Guided tissue regeneration procedures in periodontal defects.

OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose. OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.

The provided text is a 510(k) Summary for a medical device (OSSIX® Breeze) and focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. It does not describe an acceptance criteria table with reported device performance in the manner typically seen for a new AI/software device whose performance is strictly numerically quantified.

Instead, the document details a comparison of technological characteristics between the new device (OSSIX® Breeze) and a predicate device (OSSIX® Plus), supported by non-clinical testing. The "acceptance criteria" here are inherently tied to the concept of substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" refers to a series of studies (in vitro, in vivo animal, and biocompatibility) whose results collectively demonstrate this substantial equivalence.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as meeting the standards for substantial equivalence, which is a qualitative rather than strictly quantitative comparative goal in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a traditional medical device (bone grafting membrane), rather than a software algorithm with classic performance metrics like accuracy, sensitivity, and specificity, the "acceptance criteria" primarily revolve around demonstrating that the new device is as safe and effective as the predicate. The "reported device performance" is a comparative assessment.

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

• Test Set (In vivo animal study):
  • Sample Size: The document does not explicitly state the total number of animals or defects studied, only that the study design included defects of specific dimensions. It mentions "Each defect was either left untreated (negative control) or implanted with the bone grafting material OSSIX Bone and covered with the assigned membrane either OSSIX Breeze (subject device) or OSSIX Plus (predicate device)." This implies multiple defects were created and treated across a number of beagle dogs, but the exact N is missing.
  • Data Provenance: The study was an "in vivo animal study conducted in a beagle mandibular guided bone regeneration model." This indicates it was a prospective animal study. The country of origin for the data is not specified.

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

• This type of information is not applicable to this submission. The ground truth in this context is established through objective scientific measurements and observations (e.g., pathology, histology, histomorphology, micro-CT) in the animal study, not through expert human interpretation of images for diagnostic purposes.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

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, this was not done. This is a submission for a physical medical device (bone grafting membrane), not an AI/software device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

• No, this was not done. This is a submission for a physical medical device.

7. The Type of Ground Truth Used

• For the in vivo animal study, the "ground truth" was established through:
  • Pathology
  • Histology
  • Histomorphology
  • Micro-CT
• These are objective, scientific measurements and analyses performed on tissue samples and imaging from the animal model.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device requiring no "training set" in the context of machine learning or AI.

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

• Not applicable. See point 8.

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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 Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity.

The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D.

The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity.

Evecare practitioners prescribe the lens for single-use disposable wear.

The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B, which is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer, and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.

Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

The provided text is a 510(k) summary for a contact lens device, not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML device.

Specifically, the document states:
"This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." (Page 7, Section 11. Clinical study)

The information requested regarding AI/ML device performance, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, is not present in this document.

The document focuses on the physicochemical properties, manufacturing process, and comparison to a predicate contact lens device to demonstrate substantial equivalence, which is typical for a contact lens submission.

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The infrared thermometer is intended for the measurement and monitoring of human body temperature by physician or lay person. The device is not intended for infants less than three months.

Breeze Infrared Thermometer measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.When measuring the ear temperature, the ear cover provided by the manufacturer must be used.

Here's an analysis of the acceptance criteria and study information for the Suzhou Melodicare Medical Technology Co., Ltd. Infrared Thermometer, Breeze model, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are derived from the referenced standards, primarily ASTM E 1965-98 and ISO 80601-2-56.

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

• Sample Size for Test Set: A minimum of 144 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It describes the clinical study as "randomized, with a simple blind homologous control." It doesn't specify if it was retrospective or prospective, but clinical studies for device submissions are typically prospective.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For clinical thermometers, ground truth often refers to a reference thermometer reading taken by trained personnel (e.g., nurses or doctors) rather than an "expert concensus" in the diagnostic imaging sense.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. For simple clinical measurements like temperature, an adjudication process involving multiple experts for ground truth is generally not applicable in the same way it would be for complex image interpretation. The ground truth is typically a direct measurement from a reference device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure the effect size of AI on reader performance. This device is a direct measurement clinical thermometer.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the device's accuracy. The "Bench Testing" section confirms that the system complies with ISO 80601-2-56: 2009 for "performance effectiveness" and the "Clinical data" section states that "Clinical testing was conducted per ASTM E 1965-98 (2009) Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature." These standards directly evaluate the device's measurement accuracy against reference standards.

7. Type of Ground Truth Used

The ground truth used for the clinical study would be the measurements from a recognized reference thermometer or method as specified by the ASTM E 1965-98 standard. This standard outlines procedures for determining the accuracy of infrared thermometers against a reference temperature measurement in a clinical setting.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its size. Clinical thermometers, especially non-AI-driven ones, are typically calibrated during manufacturing and then validated for accuracy with a test set, rather than "trained" in the machine learning sense. If there are internal algorithms for temperature compensation or conversion, their development might involve internal data, but this is not typically disclosed or referred to as a "training set" in this context.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is described for this device, the establishment of ground truth for such a set is not applicable or detailed in the document. The device's performance relies on robust engineering, calibration against traceable standards, and validation of its accuracy.

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The Vexillum (olifilcon B) with Tangible Polymers Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Vexillum (olifilcon B) with Tangible Polymers Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Vexillum (olifilcon B) with Tangible Polymers Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Daily Breeze (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The Daily Breeze (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Daily Breeze (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.

The Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

The provided document discusses the 510(k) premarket notification for two soft contact lenses: Vexillum (olifilcon B) with Tangible Polymers and Daily Breeze (olifilcon B). It asserts substantial equivalence to a predicate device (Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lenses, K160344).

It is important to note that this document does not describe a study involving an AI/Machine Learning device. It pertains to contact lenses and their physical/chemical properties. Therefore, many of the requested criteria (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through non-clinical bench testing and comparisons of material, design, and performance characteristics.

Here's an attempt to answer the applicable parts of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of a typical AI/ML study (e.g., target specificity and sensitivity values). Instead, it demonstrates "substantial equivalence" by comparing various parameters of the new devices (Vexillum and Daily Breeze) against a legally marketed predicate device (Si-Hy, K160344). The acceptance criterion, implicitly, is that the new devices are "substantially equivalent" to the predicate in terms of their intended use, technological characteristics, and performance characteristics, and that any differences do not raise new questions of safety or effectiveness.

Here's a table summarizing the comparison parameters and their reported performance/characteristics, which effectively serve as the "acceptance criteria" for substantial equivalence in this context:

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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 Adelante® Breezeway Delivery Sheath is 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.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.

The provided text is a 510(k) summary for a medical device called the Adelante® Breezeway Delivery Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices for expanded indications. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI performance, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document explicitly states: "This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels."

This means the submission focuses solely on expanding the stated uses for a device that was previously cleared (K101497) and has not undergone any changes itself. Therefore, it relies on the previous clearance and the substantial equivalence to existing predicate devices for the expanded indications, rather than new performance studies with specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not describe a study involving performance metrics, sample sizes, expert adjudication, or AI.

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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 Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any r from heart chambers, including the left atrium via a transseptal puncture. This introducer delivery sheath of the nearl chambere, moldarity the ide port with a three-way stopcock, hemostatic valve, and a dilator. The distal tip of the sheath has side flush portholes. The dilator can be locked on to the sheath. The sheath is supplied in 10 F and two overall lengths, 63 cm and 81 cm, and dilator is supplied in two r rie sheath is oupplied in 10 r and the dilator profile curves are 55, 70, 90, 120 degrees. There are no accessories supplied with this device.

The provided text describes the acceptance criteria and the results of the functional and performance testing for the Adelante® Breezeway Delivery Sheath. However, it does not describe a study involving an AI/Machine Learning device or any human-in-the-loop performance. This document is a 510(k) premarket notification for a medical device (a catheter introducer), not an AI algorithm.

Therefore, many of the requested items related to AI/ML studies are not applicable or cannot be extracted from this text.

Here's a breakdown of the information that can be extracted, along with explanations for the missing AI-specific details:

Acceptance Criteria and Device Performance

Study Details (as applicable to a medical device, not an AI study)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify the sample sizes (number of devices tested) for the functional and performance tests. It mentions "Functional and performance testing was conducted" but provides no numerical details.
   • Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are lab/bench tests on manufactured devices, not clinical data.

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

   • Not applicable. Ground truth, in the context of device performance, is established by adherence to engineering specifications and regulatory standards, not expert consensus on interpretations. The tests appear to be physical and chemical characterizations.

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

   • Not applicable. This concept is for clinical data interpretation, not for objective physical/chemical device testing.

4. 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 study was done. This device is a physical medical instrument (a delivery sheath), not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is not an algorithm.

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

   • The ground truth for this device's performance tests is based on engineering specifications, manufacturing standards, and regulatory requirements. For example, a bond must withstand a "designated pull force," and residual levels "must be within limits."

7. The sample size for the training set:

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

8. How the ground truth for the training set was established:

   • Not applicable.

Summary regarding AI/ML aspects:
The provided document is a 510(k) summary for a traditional medical device (Adelante® Breezeway Delivery Sheath) and details its functional and performance testing against established acceptance criteria. It does not involve any AI or Machine Learning components, therefore, questions related to AI studies, training/test sets, expert adjudication, or reader studies are not applicable to the information presented. The "study" referenced is a series of benchtop and lab tests to ensure the device meets its design specifications and safety requirements.

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