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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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The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.

The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring.

The VORTRAN® APM-Plus is an airway pressure monitor. The provided text outlines the device's technical specifications and comparison to predicate devices, but it explicitly states "Clinical Studies None" under the "Performance Data" section (Page 11).

Therefore, based on the provided text, a study proving the device meets acceptance criteria through clinical performance data, a multi-reader multi-case (MRMC) study, or a standalone algorithm-only study was not conducted or provided as part of this 510(k) submission.

The performance data provided for the VORTRAN® APM-Plus focuses on:

• Biocompatibility Testing: Comparing patient-contacting materials to a cleared reference device (K103639).
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8.
• Software Verification and Validation Testing: Development in accordance with FDA guidelines and IEC 62304.
• Risk Management: Compliance with ISO 14971.
• Shelf Life: An accelerated shelf life test showing a simulated age of 1 year.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance based on clinical study data, human reader performance, or standalone algorithm performance from the given document.

The tables of "Performance Specifications" (starting on page 8) list the device's stated ranges and accuracies, essentially defining its intended performance characteristics or "acceptance criteria" from a technical specification standpoint rather than from a clinical study outcome.

However, if we interpret "acceptance criteria and reported device performance" as the technical specifications and their stated values, we can construct the following table based on the "Performance Specifications" section (pages 8-9):

Technical Acceptance Criteria and Reported Device Performance (Based on Stated Specifications)

Since "Clinical Studies None" is stated, the following information cannot be extracted from the provided document:

1. Sample sizes used for the test set and data provenance: Not applicable as no clinical test set was described.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for clinical performance. The software verification and validation would have tested the algorithm's functionality against its specified requirements, but not in a clinical "standalone" performance study.
6. The type of ground truth used: Not applicable for clinical performance. Ground truth for technical specifications would be derived from laboratory calibration and testing.
7. The sample size for the training set: Not applicable as a clinical training set is not described. This device is an airway pressure monitor, not typically an AI/ML device that requires a "training set" in the conventional sense for clinical performance. Its software capabilities are described as "microprocessor controlled" and for "calculating related characteristics" and triggering alarms (Page 4).
8. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) clearance for the VORTRAN® APM-Plus was based on substantial equivalence to predicate devices and adherence to relevant electrical safety, software, and quality system standards, without the need for clinical performance studies.

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The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient arway pressure during ventilation with a manual resuscitation device or bag/mask unit. These devices are intended to be used by or on the order of a physician.

The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures positive pressures from 0-120cm H2O during manual ventilation. The device contains a diaphragm capsule which inflates when positive pressure is introduced and collapses when the pressure decreases. Through several internal, interconnected, movements caused by the inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate pressure.

The acceptance criteria and the study that proves the device meets those criteria for the NS 120P-TRS Airway Pressure Gauge are detailed below based on the provided FDA submission document.

This device is an airway pressure monitor, not an AI/ML diagnostic device, so many of the requested fields (such as multi-reader multi-case studies, expert consensus for ground truth, training set details) are not applicable to this type of medical device submission. The study focuses on direct performance measurements (accuracy and responsiveness) against engineering specifications and a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Comparison to Predicate Device (NS 120-TRS):
While not directly an acceptance criterion for the subject device, the study also compared its performance to the predicate device.

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

• Subject Device (NS 120P-TRS) Test Sample Size: 50 units
• Predicate Device (NS 120-TRS) Test Sample Size: 10 units
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for mechanical device testing, it is implicitly a prospective performance validation study conducted by the manufacturer, Instrumentation Industries, Inc., likely at their facilities in Bethel Park, Pennsylvania, USA.

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

• Not Applicable. This is a performance validation study for a mechanical medical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for accuracy would be derived from a high-precision reference pressure measurement system.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical device testing, there's no "adjudication" in the sense of human interpretation or consensus. The performance metrics (accuracy and responsiveness) are objectively measured against predefined engineering specifications.

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

• Not Applicable. This device is a physical instrument for measuring airway pressure. It does not involve human readers interpreting images or data to make a diagnosis, nor does it use AI assistance for that purpose. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Not Applicable. This is a standalone device, but it does not employ an algorithm or AI. Its performance is measured directly as a physical instrument.

7. Type of Ground Truth Used

• Reference Measurement/Engineering Specification. For accuracy, the ground truth would be established by a precisely calibrated reference pressure source. For responsiveness, it's a qualitative observation of "instant" response against a set pressure change. This is standard for validating the performance of pressure gauges.

8. Sample Size for the Training Set

• Not Applicable. This device is a mechanical pressure gauge and does not involve AI/ML components requiring a "training set" for model development.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.

The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.

Here's a summary of the acceptance criteria and study information for the NAPA LP-15 Airway Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The study to prove the device meets acceptance criteria was a non-clinical study involving laboratory testing.

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

• Sample Size: Not explicitly stated in terms of number of devices tested. It refers to "the monitor" (singular), implying at least one device was subjected to various tests.
• Data Provenance: The tests were "laboratory tested," indicating they were conducted in a controlled environment as part of the device's premarket submission. No information about country of origin, retrospective or prospective data is provided as it was non-clinical testing.

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

• Not applicable. This was non-clinical laboratory testing against established engineering and safety standards, not a clinical study involving expert interpretation of data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This was non-clinical laboratory testing against established engineering and safety standards, not a study requiring adjudication of expert opinions.

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

• No. The submission explicitly states: "No clinical tests were submitted." An MRMC study would be a type of clinical study.

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

• While the device is a technical product, "standalone performance" in the context of AI/algorithms typically refers to its diagnostic accuracy compared to ground truth without human intervention.
• This device is an airway pressure monitor that displays readings and provides alarms. Its performance is measured directly against physical standards for accuracy and functionality, not against a "ground truth" derived from human interpretation.
• The "standalone performance" in this context is demonstrated by meeting the specified engineering and safety standards (e.g., pressure measurement accuracy), which was indeed done.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was established by calibrated reference sources for pressure measurements and the requirements outlined in the various referenced international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 14971, IEC 62304, and manufacturer's technical file for biocompatibility).

8. The Sample Size for the Training Set:

• Not applicable. This device is hardware with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software development followed IEC 62304 standards, which involves verification and validation against requirements, not training on a dataset.

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

• Not applicable, as there was no "training set" for an AI/ML algorithm. The "ground truth" for the software development was its established requirements (from the device specification) and relevant standards (IEC 62304).

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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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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 Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.

The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated. The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.

Acceptance Criteria and Device Performance for Gio Digital Manometer

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Test Report 101004 'Measurement accuracy test'" as evidence of accuracy, but the details of this test, including sample size, are not within this document.

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

This information is not provided in the document. The device is a digital pressure manometer, and its performance is likely assessed against calibrated measurement standards rather than expert-established ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance is likely measured against calibrated standards rather than requiring expert adjudication.

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

No MRMC comparative effectiveness study was mentioned. The device is a measurement tool, not an interpretive diagnostic aid requiring human reader intervention or improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done to assess the accuracy of the algorithm/device. The document states that the "Accuracy is within ± 0.4 of reading." This performance was evaluated in a "Measurement accuracy test" (Test Report 101004).

7. Type of Ground Truth Used

The ground truth for the "Measurement accuracy test" would have been established using calibrated measurement standards or reference instruments known to be highly accurate in measuring airway pressure.

8. Sample Size for the Training Set

This information is not provided. The device functions based on physical principles (pressure transducer) and likely does not employ machine learning that would require a "training set" in the conventional sense. Its "training" would be in its engineering and calibration.

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

As mentioned above, the concept of a "training set" with established ground truth in this context is not directly applicable. The device's fundamental accuracy is built into its design and calibration process, which would involve comparing its readings against highly accurate, calibrated reference pressure sources.

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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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