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Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.

Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.

The document provided is a 510(k) Premarket Notification for the Flexicare Single Use Manometer. It describes the device, its intended use, and compares it to a legally marketed predicate device (Ambu Disposable Pressure Manometer, K040991) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg

This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer.

The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP.

The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.

Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag:

• . Infant - Less than or equal to 10 kg
• Child less than or equal to 23 kg ●
• Adult Greater than 23 kg. ●

The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.

This is a 510(k) premarket notification for the Foremount Disposable PVC Resuscitator Model A1, A2, B1, B2 and Accessories, including a PEEP valve and a disposable manometer. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a dedicated table for each device component with specific numerical targets. Instead, it demonstrates performance by comparing the Foremount devices to their respective predicates or by stating that the device meets relevant ISO standards.

We can infer the acceptance criteria are met if the Foremount device's specifications and performance fall within acceptable limits defined by the predicate devices and applicable ISO standards.

Inferred Acceptance Criteria and Reported Device Performance (Resuscitator)

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The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

The Spinal Lumbar Puncture Manometer with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The manometer is considered a Class II medical device as defined in 21 CFR §880.2500, product code FMJ. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/ medical device manufacturers. Materials: PVC, Polycarbonate, HDPE. No patient contact.

Here's a breakdown of the acceptance criteria and the study information for the Spinal Manometer NRFit and Spinal Manometer LUER, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized standards and internal protocols, with the reported performance being "Pass" for all tests.

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

The document does not explicitly state the specific number of devices or test samples used for each individual performance test (e.g., liquid leakage, axial load). It mentions:

• Sterility tests: "performed using worst case devices already cleared for market and being packed in identical packaging (material and dimensions)."
• Shelf-life performance: "tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years)."

The provenance of the data is internal testing conducted by PAJUNK® GmbH Medizintechnologie, located in Geisingen, Germany, and its contract sterilizer, Sterigenics Germany GmbH, located in Wiesbaden, Germany. All testing appears to be retrospective in the sense that it's performed on manufactured devices to demonstrate compliance, rather than a prospective clinical trial.

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

This information is not provided in the document. The tests described are primarily engineering and laboratory-based performance tests against established international standards (ISO) and internal protocols. There is no mention of human expert evaluation to establish a "ground truth" in the clinical sense, as the device is for mechanical measurement and connectivity rather than diagnostic interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, quantifiable physical and chemical performance metrics against defined standards, not subjective assessments requiring expert adjudication. The result for each test is a simple "Pass" or "Fail."

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of clinical data (e.g., AI in radiology). The Spinal Manometer is a physical device for measuring pressure, not an AI or diagnostic imaging tool.

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

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is not relevant. The device operates independently of human interpretation of its internal function; humans use it to observe a reading. All performance tests evaluated the device in its intended operational context without human interpretation being part of its core "performance" beyond reading the scale.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on:

• International Standards: Adherence to ISO standards (e.g., ISO 11135, ISO 10993-7, ISO 80369-6, ISO 80369-7) defines acceptable physical and chemical properties.
• Internal Protocols: For aspects not covered by specific ISO standards (e.g., Accuracy/Durability of Markings, Glue Connection Stability), internal, presumably validated, protocols establish the acceptance criteria.
• Measurement against predefined limits: For sterilization residuals and endotoxin, specific quantitative limits (e.g., 25 ppm, 0.06 EU/ml) serve as the ground truth.

8. The Sample Size for the Training Set

There is no training set as this device is not an AI/machine learning product. The term "training set" doesn't apply.

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

Since there is no training set, this question is not applicable.

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The VORTRAN Manometer is a single patient use device intended to provide visual indication of a patient's airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.

The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.

The manometer label has three color zones of green, yellow, and red to give enhanced visual support during ventilation. The color coded scale indicates the following: green is 0 to 20 cm-H2O; yellow is 20 to 40 cm-H2O, and red is for pressures above 40 cm-H2O. The color coded scale is only for visual support and the correct ventilation pressure must be determined by the medical professional.

The provided document describes the VORTRAN Manometer, an airway pressure monitor, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria for an AI/ML powered device, nor does it detail a clinical trial or performance evaluation with statistical metrics such as sensitivity, specificity, or AUC, as would be typical for such devices.

The document primarily focuses on:

• Device Description: The VORTRAN Manometer provides visual indication of airway pressure from 0 to 60 cm-H2O.
• Technological Characteristics Comparison: A comparison of the VORTRAN Manometer's technology (pressure barrier, counter force, method of translating in-line air pressure, indicator mechanism, indicator movement, pressure limits, display increments, color coding, operating & storage temp) against several predicate devices.
• Performance Data: The performance data section explicitly states "Animal Study: None" and "Clinical Studies: None." It only mentions "The VORTRAN Manometer will indicate airway pressure with an indicator needle..." and describes its mechanical operation.
• Biocompatibility Testing: References to material compatibility with previously cleared devices.
• Compliance with Performance Standards: Adherence to ISO 5356-1 for conical connectors.

Therefore, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be extracted from this document. This typically indicates a 510(k) pathway for a traditional medical device, not an AI/ML-powered device. The "performance data" section in this document refers to bench testing of the mechanical performance, not a clinical trial or AI model validation.

However, based on the information provided, I can construct a partial response:

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

   Acceptance Criteria	Reported Device Performance
   Functionality:
   Visual indication of airway pressure	Met: The VORTRAN Manometer is intended to provide visual indication of a patient's airway pressure. The indicator needle shows PIP and PEEP in cm-H2O, associated with a linear rack and pinion gear tied to a moveable diaphragm. (Performance Data section)
   Pressure range from 0 to 60 cm-H2O	Met: The device provides pressure readings from 0 to 60 cm-H2O. (Device Description, Performance Data section)
   Accuracy:
   ±2 cm-H2O for 0 to 20 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O. (Device Description section)
   ±3 cm-H2O for 20 to 40 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O. (Device Description section)
   ±5 cm-H2O for pressures above 40 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±5 cm-H2O for pressures above 40 cm-H2O. (Device Description section)
   Connectivity:
   Connection to breathing circuit via 22mm male-female adapter	Met: Connection to a breathing circuit via a 22 mm male-female adaptor, and accommodates connections through the option of a 22 mm tee or 15 mm port. Also, connected via a "Tee" 15 mm/22 mm ID/OD or "Vertical" plastics connector. (Device Description, Clinical Application sections)
   Biocompatibility:	Met: The device uses materials (Polycarbonate, Acetal, Silicon) for components with indirect patient contact that are the same as predicate devices previously cleared by FDA. (Biocompatibility Testing section)
   Mechanical Standard Compliance:	Met: Compliance with ISO 5356-1 Anaesthetic and respiratory equipment -- Conical connectors - Part 1: Cones and sockets. (Compliance with Performance Standards section)

   Note: The "acceptance criteria" here are derived directly from the device's specified performance characteristics and design requirements mentioned in the document, as no explicit "acceptance criteria table" for a study was provided. The "reported device performance" are the statements made in the document regarding the device's characteristics.

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

   • No information provided regarding a test set sample size or data provenance. The document explicitly states "Clinical Studies: None" and "Animal Study: None." The performance data section describes the mechanical operation and accuracy specifications, likely derived from bench testing, not a clinical test set. Data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. There was no clinical test set for which expert ground truth would be established. The accuracy claims are based on engineering specifications and likely bench testing/calibration.

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

   • Not applicable. No test set requiring expert adjudication was described.

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 mechanical manometer, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

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

   • Not applicable. This is a mechanical device, not an algorithm.

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

   • For the accuracy claims, the ground truth would typically be established by validated calibration standards and highly accurate reference pressure measurement equipment during bench testing. This is not explicitly stated in the document but is implied by the nature of the device (a manometer).

8. The sample size for the training set:

   • Not applicable. This device is a mechanical manometer; it does not involve machine learning or a training set.

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

   • Not applicable. This device is a mechanical manometer; it does not involve machine learning or a training set.

In summary, the provided document pertains to a traditional, mechanical medical device (manometer) undergoing a 510(k) clearance process based on substantial equivalence, primarily supported by bench testing and comparison to predicate devices, rather than a clinical study involving human subjects or an AI/ML algorithm validation study. Therefore, much of the requested information, which is relevant for AI/ML powered devices, is not available or applicable.

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The Aerobika* Oscillating Positive Expiratory Pressure device intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.

The Aerobika* OPEP with Manometer device combines Positive Expiratory Pressure (PEP) with oscillations upon exhalation with visual feedback relative to the patient's expiratory pressure. The device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure. The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

This document, a 510(k) Premarket Notification for the Aerobika* OPEP with Manometer, describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about clinical studies with human participants. Therefore, many of the requested details about acceptance criteria for clinical performance, ground truth, expert adjudication, or MRMC studies are not applicable or available in this document.

Here's a breakdown of the available information:

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

The document details several non-clinical tests performed. While explicit "acceptance criteria" are not numerically stated in a table format, the narrative indicates that the device "meets specifications and performs comparably to the predicate Aerobika* OPEP device." The performance reported is that the device did meet these specifications.

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

This document describes non-clinical laboratory testing. Specific sample sizes for each mechanical or environmental test are not provided in this summary. The data provenance is Trudell Medical International, located in London, ON, Canada, conducting design verification and validation activities. The studies are prospective in nature as they are 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 (e.g. radiologist with 10 years of experience)

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring expert ground truth establishment.

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

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring adjudication.

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 diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a mechanical OPEP device, not an algorithm. The "standalone" performance refers to the device's inherent mechanical function. The non-clinical testing evaluates this.

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

For the non-clinical tests, the "ground truth" is established by engineering specifications, recognized standards (like ISO 10993-1:2009 for materials), and the performance characteristics of the legally marketed predicate device (Aerobika* OPEP device, K123400).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

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

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To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits.

For patients that the clinician desires to monitor or measure airway or circuit pressure.

Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

The Westmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.

The device consists of:

• 1. Clear housing with a printed pressure scale
• 2. A float with indicator and
• 3. Spring

It functions by reacting to the positive present in the ventilation device. When pressure is in the device the float moves up or down to indicate the pressure of the system. This manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range -0-60 cm H2O. The performance characteristics are that the measured pressures are accurate to:

• • 3 cm H2O up to 60 cm H2O
    It is a single patient, disposable, packaged non-sterile device.

Here's a breakdown of the acceptance criteria and study information for the Disposable Pressure Manometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device K003497 had different accuracy criteria:

• ± 1 cm H₂O from 0-10 cm H₂O
• ± 2 cm H₂O from 10-40 cm H₂O
• ± 3 cm H₂O above 40 cm H₂O
  The proposed device set its own accuracy criteria, consistent with reference devices (K040991 Ambu, K954486 Mercury Medical) for a wider pressure range.

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

• Sample Size for Test Set: The document states that "All samples met the pass/fail criteria" for Accuracy and Repeatability, Aging, Mechanical, Environmental, and Positional Orientation tests. It also mentions "Samples were dropped," "Samples which had real-time aging and samples in accelerated aging were pressurized," and "Each sample was tested multiple times." However, the exact number of samples (N) used for the test set is not explicitly stated in the provided text.
• Data Provenance: Not specified, but likely from in-house testing by Westmed, Inc. No mention of geographical origin or whether it's retrospective or prospective is made.

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

• Number of Experts: Not applicable. This device is a measurement tool (manometer), and ground truth for its performance is established by comparison to a calibrated standard (digital manometer), not expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Ground truth for a physical measurement device's accuracy and performance is typically determined against established calibration standards and engineering specifications, not human adjudication.

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

• MRMC Study Done: No. This is a physical medical device (disposable pressure manometer) used for objective measurement, not an AI or diagnostic imaging device that requires human interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, in essence. The documented "Non-Clinical Testing Summary" details the performance of the Westmed DPM device itself, including its accuracy, repeatability, and resilience to aging, mechanical stress, environmental conditions, and positional changes. This testing is performed on the device without a human in the loop, directly measuring its output against a digital manometer.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's accuracy and repeatability was established by comparison with a digital manometer (implicitly, a calibrated standard). The "Summary: Accuracy and Repeatability" section states: "Samples were pressurized across the range and confirmed with the digital manometer."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. Its functionality is based on mechanical principles (spring and float), not learned patterns.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits, For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home. Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: 1. A flexible nipple for attachment to a sampling / pressure port. 2. Clear housing with a printed pressure scale 3. A float with indicator 4. Spring. When positive pressure is present in the ventilation device, the manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range - 0-60 cm H2O. Besmed intends offer three (3) models / styles of their disposable pressure manometer. They are identical in design, function and materials. The differences are: Pressure range. 0 0 60 cm H2O 0 40 cm H2O · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design Note the accuracy and performances are identical . Indicator strip . O All models have the pressure range embossed on the housing o A color strip / indicator may also be included to indicate the pressure. It is a single patient, disposable, packaged non-sterile device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.

The Intersurgical 7160030 Manometer is an inline manometer for monitoring the pressure delivered to patients via resuscitation systems and Mapleson C breathing circuits. The 7160030 manometer has an operating range of 0 - 60 mbar and a stated accuracy. of +/- 10mbar. The pressure is read where the internal red indicator disk lines up with the pressure indication mark on the outside of the transparent manometer cylinder. The 7160030 manometer specify the patient pressure via a brightly colored indicator. The indicator moves in one axis along a transparent cylinder. The diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. The Manometer connects to the resuscitator / Mapleson C system via a 3 way, 15mm Female/22mm Male - 22mm Female connector. The 3-way connector tapers are compliant with ISO 5356-1. The manometer can be rotated to the desired orientation for ease of use via a friction fit elastomeric elbow. The 7160030 Manometer is single patient use.

The Intersurgical 7160030 Manometer's acceptance criteria and performance are detailed in the provided document.

1. Acceptance Criteria and Reported Device Performance:

Note: The document only provides "stated accuracy" for the predicate at 10, 20, & 30 cmH2O as ± 2 mbar (singular value). It's assumed for clarity in the table that this applies individually. Similarly, "measured accuracy" for the predicate at 10, 20, & 30 cmH2O is also given as ± 2 mbar.

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

The document does not explicitly state the sample size used for the test set regarding the accuracy measurements. It mentions "Nonclinical tests submitted to demonstrate substantial equivalence for the Manometers include Vertical and Horizontal Pressures, Weight and Size and Tapers when compared to the legally marketed device." However, the number of devices or measurements taken during these tests is not specified.

The data provenance is not explicitly mentioned as a country of origin or whether it was retrospective or prospective. It is implied to be from internal testing conducted by Intersurgical Incorporated.

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

Not applicable. The ground truth for device performance (e.g., pressure accuracy, physical dimensions) is established through instrument-based measurements and compliance with engineering standards, not through expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As the testing concerns objective device performance metrics, adjudication by experts for discrepancies is not relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices that involve human analysis of output (e.g., imaging devices with radiologists). The Intersurgical Manometer is a physical measurement device, so such a study would not be applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was done. The "Summary of Testing" section describes nonclinical tests for Vertical and Horizontal Pressures, Weight, Size, and Tapers, as well as biocompatibility and connector compliance, all demonstrating the device's inherent performance.

7. The Type of Ground Truth Used:

The ground truth used for performance validation was based on established measurement standards (e.g., pressure calibrations), physical measurements, and regulatory standards (ISO 10993-1 for biocompatibility, ISO 5356-1 for connectors).

8. The Sample Size for the Training Set:

Not applicable. The Intersurgical 7160030 Manometer is a mechanical device, not an AI/algorithmic system. Therefore, there is no "training set" in the context of machine learning.

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 Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.

Ventlab Pressure-Chek Disposable Column Manometer

Analysis of Ventlab Pressure-Check Disposable Column Manometer (K120118)

This document is a 510(k) clearance letter from the FDA. It declares the Ventlab Pressure-Check Disposable Column Manometer substantially equivalent to a predicate device. However, it does not contain details about the specific acceptance criteria or a study proving the device meets those criteria.

FDA 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The detailed study data outlining performance metrics against specific acceptance criteria is usually submitted by the manufacturer as part of their 510(k) submission, but this information is not typically included in the public-facing clearance letter.

Therefore, based solely on the provided text, I cannot answer most of your questions as the requested information is not present. The document focuses on the regulatory clearance process rather than specific performance study details.

Here's what I can extract from the provided text and what I cannot:

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

• Cannot provide. The document does not specify acceptance criteria or report specific device performance metrics from a study.

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

• Cannot provide. The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot provide. The document does not describe any expert ground truth establishment process or qualifications.

4. Adjudication method for the test set:

• Cannot provide. The document does not describe any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot provide. This device is a manometer (a physical device for measuring pressure), not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be applicable or expected for this type of product.

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

• Cannot provide. As noted above, this is a physical manometer, not an algorithm.

7. The type of ground truth used:

• Cannot provide. The document does not describe the specific ground truth used for any testing. For a manometer, ground truth would typically involve reference pressure measurements from calibrated equipment.

8. The sample size for the training set:

• Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no training set for this type of device.

In summary, the provided FDA clearance letter confirms the regulatory status of the Ventlab Pressure-Check Disposable Column Manometer but does not contain the detailed technical study information you are requesting. That information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in its entirety.

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The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.

The NF-009 Pressure Manometer is a low pressure gauge with a range of -20 to 80 cmH2O in marked increments of 1 cm H2O. The gauge has color coding green, yellow and red. The Manometer provides visual indication of airway pressure during ventilation or resuscitation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NF-009 Pressure Manometer:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are indirectly stated by referring to the accuracy of the predicate devices. The NF-009 significantly exceeds these criteria with a reported accuracy of within 1 cmH2O across its operational range.

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

• Sample Size: Not explicitly stated. The text mentions "the comparison table" and implies testing across the operational range, but no specific number of measurements or devices tested is provided.
• Data Provenance: Not specified. It's an internal company test ("Performance Data"), but details on whether it's retrospective or prospective, or country of origin, are absent.

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

• Experts Used: Not applicable. The ground truth was established by a "Reference Gauge" and a "Digital Gauge," which are instruments, not human experts.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was based on instrument readings, not expert human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This device is a manometer, a direct measurement tool. Its performance is assessed against reference instruments, not human interpretation in a multi-reader, multi-case study.

• Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: Yes, in essence. The "Performance Data" section describes the NF-009's accuracy when measured against other gauges. This is a standalone performance assessment of the device, independent of human interaction beyond operating the device and reading the values. It's not an algorithm, but a mechanical device.

7. The Type of Ground Truth Used

• Ground Truth Type: Instrumental/Reference Standard. The accuracy was determined by comparing the NF-009's readings to those of a "Reference Gauge" and a "Digital Gauge."

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a mechanical manometer, not a machine learning algorithm, therefore there is no training set.

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

• Ground Truth Establishment: Not applicable, as there is no training set.

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