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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms:

Acinetobacter spp. (Acinetobacter baumannii)

Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)

Pseudomonas aeruginosa

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The provided FDA 510(k) clearance letter pertains to The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on the system. The indications for use specify its application for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa.

Unfortunately, the provided document does not contain the detailed information required to specifically answer your questions about acceptance criteria, study methodology (sample size, data provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. This clearance letter is a formal notification of substantial equivalence and outlines the intended use and regulatory classifications, but it does not include the full summary of safety and effectiveness data that would typically contain such study specifics.

To get the information you're looking for, you would generally need to refer to the 510(k) Summary document, which is usually part of the full 510(k) submission and is publicly available through the FDA's 510(k) database. This summary typically provides a more detailed overview of the performance studies conducted to support the clearance.

Therefore, I cannot populate the table or answer most of your specific questions based solely on the provided text.

However, I can extract what is implied about acceptable performance:

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

Based only on the statement "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms," we can infer that the device met the manufacturer's internal acceptance criteria for performance for these organisms, as the FDA has cleared it. Without the 510(k) summary, specific numeric thresholds for performance metrics (e.g., Essential Agreement, Category Agreement) for in vitro diagnostic susceptibility tests are not provided in this letter.

• Acinetobacter spp. (Acinetobacter baumannii)
• Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
• Pseudomonas aeruginosa |

The following questions cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (Note: This device is an in vitro diagnostic for antimicrobial susceptibility testing, not typically an AI-assisted diagnostic read by a human expert in the context of imaging or pathology. An MRMC study is highly unlikely for this type of device.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (The device itself is the "standalone" test; human interpretation is involved in setting up the test and reading the results, although it's an automated or semi-automated system. Performance is typically measured against a reference method.)
7. The type of ground truth used. (For AST devices, the ground truth is typically a reference method like broth microdilution or agar dilution, performed according to CLSI guidelines.)
8. The sample size for the training set. (While there might be "training" in the sense of model development for an automated reader, a primary training set in the AI/ML sense is not typically discussed for this type of in vitro diagnostic device, which relies on chemical reactions and optical detection.)
9. How the ground truth for the training set was established. (Similar to point 8, this question's premise might not directly apply to this type of device.)

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This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.

This product is not intended to be used on patients with bypassed upper airways.

This product is not intended to be life-sustaining or life-supporting.

This product is not intended for apneic ventilation.

The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.

The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.

The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.

Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.

Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source

This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.

1. Table of Acceptance Criteria and Reported Device Performance:

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OPT94X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals.

MYOPT9X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and and humidified respiratory gases to the upper airway.

This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

The F&P Optiflow+ Nasal Cannula range is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy.

The F&P Optiflow+ Nasal Cannula range is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.

The provided FDA 510(k) clearance letter and summary for the F&P Optiflow+ Nasal Cannula Range does not contain specific acceptance criteria or an analytical study proving the device meets those criteria.

This submission is for a labeling change only. The document explicitly states:

• "The modification in scope of this 510(k) submission is to change the labeling of the subject device only, specifically to the Indications for Use statement."
• "The subject device's technological characteristics, material composition, and intended use remain identical to those of the predicate device."
• "No new performance or biocompatibility testing was conducted on the subject device since the device design is identical to the predicate device."

Therefore, the information requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be extracted from this document because such studies were not conducted for this specific 510(k) submission.

The clearance is based on the device being substantially equivalent to a previously cleared device (F&P Optiflow+ Nasal Cannula range, K162553), with the only change being an updated Indications for Use statement to be more defined and aligned with current labeling requirements. The original predicate device (K162553) would have had performance data supporting its clearance, but that data is not detailed in this particular document.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: Not provided in the document as no new performance testing was conducted. The document states the device's characteristics and performance are identical to the predicate device.
2. Sample Size for Test Set and Data Provenance: Not applicable, as no new performance testing was conducted.
3. Number of Experts and Qualifications: Not applicable, as no new clinical study requiring expert review was conducted.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no new clinical study was conducted.
6. Standalone Performance (Algorithm only): Not applicable, as this is a medical device (nasal cannula), not an AI/algorithm-based device.
7. Type of Ground Truth Used: Not applicable, as no new performance testing was conducted.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Established: Not applicable.

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A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.

SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.

The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.

The mask has two models: A-Model and Sleeplab (SL) A-Model. Both models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

I am sorry, but based on the provided FDA 510(k) Clearance Letter and the accompanying 510(k) Summary, there is no information provided regarding acceptance criteria for an AI/ML powered medical device, nor any study details that would prove such a device meets these criteria.

The document describes the clearance of a physical medical device, the F&P Nova Nasal Mask, which is a non-invasive positive airway pressure (PAP) therapy nasal mask. The performance data section lists standard engineering and biocompatibility tests typically performed on such devices (e.g., cleaning validation, leak, CO2 rebreathing, resistance to flow, vibration and noise, dead space analysis, human factors, mechanical integrity, shelf-life, and various ISO standards related to masks and biological evaluation).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study for an AI-powered device using this document. The information you are asking for (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are specifically relevant to the validation of AI/ML algorithms in medical devices, which this document does not cover.

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Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is intended to determine susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 demonstrated acceptable performance to determine susceptibility to Aztreonam/Avibactam against the following microorganisms:

Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, and Proteus mirabilis)

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

The provided FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test Disc (ASTD), specifically the "Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50". This type of device is a diagnostic tool used in microbiology laboratories to determine how effective certain antimicrobials are against specific microbial infections.

The information typically requested for AI/ML-based medical devices (such as acceptance criteria, ground truth establishment for training/test sets, sample sizes, MRMC studies, etc.) is not directly applicable to this type of traditional in vitro diagnostic device (IVD).

Here's why and what can be extracted from the document:

• Nature of the Device: The Aztreonam/Avibactam Disc is a physical disc impregnated with antimicrobial agents. Its "performance" refers to its ability to accurately measure the zone of inhibition (a clear area around the disk where bacteria do not grow), which then correlates to the susceptibility or resistance of the microorganism to the antibiotic. It's not an AI/ML algorithm that interprets or processes complex images or data in an automated way.
• Acceptance Criteria for ASTDs: For ASTDs, acceptance criteria typically involve demonstrating a high degree of correlation between the zone diameters produced by the disc and the Minimum Inhibitory Concentration (MIC) values obtained by a reference method (e.g., broth microdilution). This often involves:
  • Essential Agreement (EA): The percentage of isolates for which the disc test and the reference method produce results that categorize the isolate into the same interpretive category (Susceptible, Intermediate, Resistant).
  • Category Agreement (CA): A stricter measure, where both the zone diameter and MIC fall within defined ranges for a specific category.
  • Major Discrepancies (MD): When the disc test indicates Susceptible, but the reference method indicates Resistant.
  • Very Major Discrepancies (VMD): When the disc test indicates Resistant, but the reference method indicates Susceptible.
  • Minor Discrepancies (mD): Discrepancies between Intermediate and Susceptible/Resistant categories.
    The FDA expects these discrepancy rates to be below certain thresholds (e.g., VMD

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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for "The Sensititre YeastOne Susceptibility System with Micafungin" does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It covers:

• The trade/device name, regulation number, regulatory class, and product code.
• Confirmation of substantial equivalence.
• Information about general controls, special controls, the predetermined change control plan (PCCP), and other applicable regulations (Quality System, adverse event reporting, UDI Rule).
• Indications for Use of the device.

It specifically lacks the following information that would be necessary to address your request:

1. Acceptance criteria table and reported device performance: The letter does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) or the thresholds for acceptance (e.g., "required to be > X%").
2. Study details (sample size, data provenance, expert counts, adjudication, MRMC, standalone performance, ground truth type, training set details): The letter does not include any information about the design or results of the studies used to validate the device's performance. For an Antimicrobial Susceptibility Test (AST) system, performance is typically assessed by comparing its results (categorization into Susceptible, Intermediate, Resistant) against a reference method.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission summary publically available on the FDA website, or the relevant performance study reports and data that were provided by Thermo Fisher Scientific to the FDA for review. The clearance letter itself is a summary of the FDA's decision, not the underlying data or study methodology.

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The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for meropenem in the dilution range of 0.015 - 32 ug/ml for testing fastidious isolates on the Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.

Meropenem has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Streptococcus spp. Viridians group Haemophilus influenzae

Not Found

The provided text is a 510(k) clearance letter from the FDA for an Antimicrobial Susceptibility Test Powder. It does not contain the details of acceptance criteria or a study proving that a device meets such criteria, as it relates to an AI/ML-driven medical device. The document is an administrative letter confirming the substantial equivalence of a new version of an in vitro diagnostic product (Sensititre) used for antimicrobial susceptibility testing, specifically for meropenem against certain bacterial isolates.

Therefore, I cannot extract the information requested about acceptance criteria, device performance, test set details (sample size, provenance, expert adjudication, MRMC study, standalone performance), ground truth, or training set details. This information would typically be found in a detailed study report or premarket submission for an AI/ML device, not in a 510(k) clearance letter for an in vitro diagnostic for antimicrobial susceptibility.

In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and study proving device performance for an AI/ML device.

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A-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home.
SLA-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home and for multiple-patient use in the hospital or other clinical settings where proper disinfection of the device can occur between patient uses.

The F&P Nova Micro Pillows Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal pillows mask with a silicone seal that seals the nasal airway entrance of the Nova Micro Pillows Mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The Nova Micro Pillows Mask features a pillows cushion with prongs that extrance of the patient's nasal nares, held in place by adjustable headgear straps. The Nova Micro Pillows Mask is a prescription-only device, provided in a non- sterile state. The F&P Nova Micro Pillows Maskrange is available in three cushion sizes – Small, Medium, and Large. The mask has two models: A-Model and Sleeplab (SL) A-Models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

This document is a 510(k) Premarket Notification from the FDA regarding the F&P Nova Micro Pillows Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.

However, the provided text does not contain the specific information requested about acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. This document describes a medical device (a CPAP mask) that is not an AI/ML device according to the information provided. Therefore, there is no discussion of performance metrics like accuracy, specificity, sensitivity, or the methodology of an AI/ML study (e.g., sample size for AI training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment).

The "Performance Data" section (Section VII) lists various non-clinical tests performed on the mask, such as Cleaning Validation, Leak, Dead Space Analysis, CO2 Rebreathing, Pressure-Flow Curve, Resistance to Flow, Vibration and Noise, Human Factors/Usability Engineering, Mechanical Integrity, and Shelf-Life. These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/ML algorithm.

Therefore, I cannot provide the requested table or details about an AI/ML study from the given text. The information is simply not present because the device described is not an AI/ML device.

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When used in NIV mode:
The Airvo 3 NV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.

When used in High Flow mode:
The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NVV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals.

The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport.

AirSpiral NIV tube and chamber kit (900PT573):
For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.

The subject device, F&P Airvo 3 NIV is a respiratory support device for the delivery of High Flow and NIV (Non-Invasive Ventilation) therapy intended to treat spontaneously breathing patients who would benefit from receiving High Flow or respiratory pressure support. The Airvo 3 NIV is NOT to be used for life-supporting or life-sustaining purposes.

The Airvo 3 NIV is a non-implantable, prescription-only device, provided in a non-sterile state, and intended to be used by healthcare professionals, namely respiratory therapists, doctors and nurses in hospitals. When used in High Flow mode, the Airvo 3 NIV delivers gas at flow rates of between 2-70 L/min. The Airvo 3 NIV also has three non-invasive ventilation therapy modes: CPAP, Bi-Level S/T and Bi-Level PCV.

The AirSpiral NIV Tube and Chamber Kit is a single limb circuit kit designed for use with the Airvo 3 NIV device, for non- ventilator dependent, spontaneously breathing adult patients with respiratory insufficiency.

The provided text is a 510(k) Summary for the F&P Airvo 3 NIV device. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this document as it does not describe an AI/ML device or a study of its clinical performance against specific acceptance criteria for such an algorithm.

However, I can extract information related to performance testing from the "PERFORMANCE DATA VII." section, which includes "Bench / Performance Testing."

Here's an attempt to answer your request based on the provided document, noting the limitations due to the nature of the submission:

Acceptance Criteria and Study for F&P Airvo 3 NIV (K233643)

The F&P Airvo 3 NIV is a respiratory support device and not an AI/ML driven diagnostic or therapeutic device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to establish substantial equivalence to predicate devices and ensure general safety and effectiveness in line with recognized medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing conducted but does not explicitly state numerical acceptance criteria or reported device performance values in a table format. Instead, it states that the testing "demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device" and that "The testing demonstrated the appropriate biocompatibility profile for the device" and "The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 and AIM Standard 7351731 Rev. 3.00 2017-02-23" as well as "Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012." For reprocessing, "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011". For comparative performance, it states "Comparative performance testing was performed to demonstrate substantial equivalence."

Given the information, a table with specific numerical acceptance criteria and performance values cannot be fully populated as requested for items like blending accuracy, flow rate accuracy, etc. The document implies compliance with relevant standards as the "acceptance criteria."

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

• Not applicable for an AI/ML context. This device is hardware with embedded software, thus performance testing involves engineering verification and validation, not a test set of patient data for an algorithm. The testing described focuses on functional aspects of the device, not an algorithm's performance on a dataset.

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

• Not applicable for an AI/ML context. Ground truth, in the sense of clinical expert assessment of data, is not mentioned in relation to the device's technical performance testing.

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

• Not applicable for an AI/ML context. This type of adjudication is relevant for resolving discrepancies in expert interpretations of clinical data, which is not described 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 device is not an AI-assisted tool for human readers.

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

• Not applicable. This device does not feature a standalone algorithm performing a diagnostic or therapeutic task.

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

• For engineering and performance testing described (electrical safety, EMC, flow rate accuracy, etc.), the "ground truth" would be established physical and engineering principles, international standards, and measurements from calibrated reference instruments. It is not clinical "ground truth" as typically defined for AI/ML performance.

8. The sample size for the training set:

• Not applicable. There is no mention of an AI/ML training set. Software verification and validation refer to standard software engineering practices.

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

• Not applicable. There is no mention of an AI/ML training set or its associated ground truth establishment.

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