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The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use

Westmed has designed several 0%CO2 nasal cannula / exhaled gas sampling devices. They include:

• . Nasal cannula style that can provide supplemental O2 and sample exhaled gases at only the nares and
• Nasal cannula style that can provide supplemental O2 and sample exhaled gases at both ● the nares and at the mouth
  The device configurations include nasal cannula that have a division to deliver oxygen through one nare and to sample exhaled gases through the other. There is also an oral sampling style which is positioned near the mouth to sample exhaled gases if the patient is a mouth breather.
  The device includes a length of standard oxygen tubing and gas sampling lines.

This document describes Westmed's Gas Sampling Cannula with O2 delivery, which is intended to deliver supplemental oxygen and sample expired gases. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance through a dedicated study with a predefined test set. Therefore, some requested information may not be directly available from the provided text.

Here's an analysis based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence to predicate devices through comparative testing. The performance is reported in terms of equivalence to the predicate devices.

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

The document does not specify the exact sample sizes (e.g., number of units, number of simulated breathing cycles) used for the bench testing. It only mentions "comparative testing" under "several simulated breathing conditions."

• Sample Size: Not explicitly stated for specific tests.
• Data Provenance: The testing was conducted as "Bench Testing" by Westmed, Inc. The document does not specify the country of origin of the data beyond implying it was performed by the submitting company. The tests were non-clinical (i.e., not performed on human subjects) and are therefore retrospective.

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

This information is not applicable and not provided. The "ground truth" for this device's performance is based on physical and chemical measurements (e.g., CO2 concentration, waveform characteristics, tensile strength) against engineering specifications or comparative performance with predicate devices, not subjective expert assessment of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the testing involves objective measurements rather than subjective assessments requiring adjudication, no such method is described.

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

No MRMC study was performed or described. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers interpret medical images or data. The Westmed device is a gas sampling and oxygen delivery cannula, not an interpretive device.

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

This concept is not directly applicable to a physical medical device like a cannula. The device's performance is inherent in its physical and functional characteristics. The "bench testing" described evaluates the device in a standalone manner (without a human patient), but it's not an "algorithm only" study as understood in AI/software contexts.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation was based on:

• Objective Measurements: Such as CO2 concentrations, waveform characteristics, and mechanical properties (tensile strength).
• Comparison to Predicate Devices: Performance was deemed equivalent to the predicate devices (K010024 – Oridion and K011050 – Oridion). This implies that the performance of the predicate devices served as a de facto "ground truth" or benchmark for acceptable performance.
• Standardized Testing: Biocompatibility testing followed ISO 10993 standards, which define the "ground truth" for biological safety.

8. Sample Size for the Training Set

This information is not applicable. The Westmed device is a physical medical device, not a machine learning algorithm that requires a "training set."

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

This information is 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.

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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The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.

The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable.

The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece.

In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery.

There are two different Y-adapters available that act as "waveguides" to direct sound waves from the audio speaker in the HHT to the mouthpiece that is held in the patient's mouth in the same manner as with other breathing treatment mouthpieces.

The purpose of the Y-adapters is two-fold:

• · To direct the sound waves into the airway opening, and
• · To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.

Here's a breakdown of the acceptance criteria and study information for the Vibralung Acoustical Percussor, based on the provided document:

Acceptance Criteria and Device Performance

The document describes a substantial equivalence comparison rather than explicitly stating numerical acceptance criteria for device performance against predefined thresholds. Instead, the device's performance is deemed "substantially equivalent" to predicate devices, implying that its performance is comparable and acceptable. The core "performance" criteria are based on its ability to generate acoustic frequencies and provide Positive Expiratory Pressure (PEP) within ranges consistent with the physiological effects of the predicate devices.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance:

Study Information

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

• Study 1: 10 subjects (mild to moderate Cystic Fibrosis). Retrospective/Prospective information is not explicitly stated, but the description "were subjected to two treatments... on two different days" suggests a prospective, interventional design. The country of origin is not specified.
• Study 2: 11 subjects. Retrospective/Prospective information is not explicitly stated, but the description "designed to assess the effects... for five days" suggests a prospective, interventional design. The country of origin is not specified.
• Non-clinical Testing: Details on sample size for components/materials are not provided, only the types of tests performed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the sense of independent review or adjudication of study outcomes. The studies focused on objective physiological measurements (LCI, sputum production, pulmonary function) and safety assessments.

4. Adjudication Method for the Test Set:

Not applicable. The studies did not involve subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

Not applicable. This is a medical device for airway clearance, not an algorithm. The "standalone" performance would be its inherent physical and physiological effects, which are what the non-clinical and clinical studies assess.

7. The Type of Ground Truth Used:

• Clinical Studies (Study 1 & 2): Physiological measurements and clinical outcomes, such as:
  • Lung Clearance Index (LCI)
  • Pulmonary function (FVC, FEV1)
  • Peripheral oxygen saturation (SaO2)
  • Total sputum production (wet weight, pellet weight, dry weight)
  • Patient symptoms and safety assessments.
• Non-Clinical Testing: Engineering and performance specifications, such as inspiratory resistance, airway pressure, sound pressure level, mechanical dead space, particle characterization (for aerosol performance), acoustical testing (frequency ranges), electrical safety (IEC standards), accelerated aging, and cleaning validation.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning system that requires a "training set."

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

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

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The Westmed, Inc. BlockAide™ Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

The BlockAide™ Filter, manufactured by Westmed, Inc., is a disposable, single-use barrier type, bi-directional filter fabricated from a plastic resin that is supplied to the customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.

The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from an opaque plastic and the machine housings are fabricated from the same plastic but with different number molded into the housing to identify machine end. The numbered end fits the machine and the opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.

The provided text describes the Westmed, Inc. BlockAide™ Filter, a disposable bacterial/viral filter, and its non-clinical testing to demonstrate substantial equivalence to predicate devices. The information focuses on design characteristics and performance metrics rather than a typical clinical study with human subjects.

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

• Note: The document explicitly mentions that the BlockAide™ Filter "met the recommendations of the American Thoracic Society's Standardization of Spirometry (1994 update) for minimal recommendations for Diagnostic Spirometry Equipment with in-line filters; i.e., that the measuring equipment as attached to the filter have air flow resistance of less than 1.5cm H2O/L/s." The BFE and VFE criteria are generally accepted performance standards for such filters, even if a specific numerical "acceptance criteria" isn't explicitly stated in the document beyond the achieved performance.

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

The document primarily describes non-clinical bench testing rather than studies involving human subjects or clinical data. Therefore, the concept of a "test set" in the traditional clinical sense is not directly applicable.

• Sample size for testing: Not explicitly stated for each test (BFE, VFE, Airflow resistance, Biocompatibility). The tests likely involved a sufficient number of devices/samples to ensure statistical validity for the respective tests, but the exact count is not provided.
• Data Provenance: The tests would have been conducted in a laboratory setting, likely in the United States, given Westmed, Inc. is based in Tucson, AZ, USA, and the submission is to the FDA. The data is prospective in the sense that the tests were performed specifically for 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. For non-clinical bench testing of a medical device like a filter, "ground truth" is established by adherence to recognized testing standards and validated methodologies (e.g., ISO, ASTM standards for filtration and biocompatibility, or established protocols for airflow resistance). The expertise lies in the laboratory personnel conducting these tests and their adherence to these standards. There is no mention of external experts establishing a "ground truth" for the test results themselves.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting ambiguous clinical data or images. This document describes objective, quantitative non-clinical tests with measurable outcomes.

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 physical filter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

Not applicable. This device is a physical filter, not an algorithm.

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

The "ground truth" for the performance claims is derived from objective, quantifiable laboratory measurements obtained through standardized testing protocols:

• Bacterial/Viral Filtration Efficiency: Established by challenging the filter with known concentrations of bacterial or viral aerosols and measuring the reduction in concentration downstream. The "ground truth" is the measured efficiency against the challenge organism/particle.
• Airflow Resistance: Measured directly using calibrated flow and pressure sensors. The "ground truth" is the physical property of resistance to flow.
• Biocompatibility: Determined by standardized in-vitro and/or in-vivo tests as per ISO 10993-1 guidelines (cytotoxicity, sensitization, intracutaneous reactivity). The "ground truth" is the biological response observed under controlled conditions.

8. The sample size for the training set

Not applicable. The BlockAide™ Filter is a physical medical device, not a machine learning or AI model, so there is no "training set."

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

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

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AccuFlo & AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert.

The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes

The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

The AccuFlo & AccuFlux models are both disposable, non-electric infusion pumps that deliver precise volume of medication at predetermined flow rate for IV therapy.

The provided text describes a 510(k) premarket notification for the AccuFlo & AccuFlux disposable infusion pumps. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance.

The document primarily focuses on:

• Device Description and Intended Use: Disposable, non-electric infusion pumps for precise medication delivery.
• Technological Characteristics: Equivalence to predicate devices and compliance with various international standards (IEC, ISO) related to medical devices, biocompatibility, packaging, sterilization, and risk management.
• Regulatory Information: 510(k) summary, contact information, date prepared, proprietary and common names, classification, predicate devices, and the FDA's clearance letter stating substantial equivalence.

Therefore, I cannot provide the requested information as it is not present in the given text.

The prompt's questions (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth) are typically relevant for AI/ML-based diagnostic devices, which this product (a non-electrically powered disposable infusion pump) is not. Its "performance" would be related to its flow rate accuracy, duration of infusion, material biocompatibility, and manufacturing quality, not diagnostic accuracy based on an algorithm.

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Use during mask ventilation to assist in the determination of a patent airway.

Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.

Not Found

This document is a 510(k) premarket notification letter from the FDA for a medical device called "Pedi CO2 Easy". It primarily focuses on the regulatory approval process and includes the indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based solely on this document. The document confirms that the device is "substantially equivalent" to a legally marketed predicate device, which is the basis for its approval, but it does not detail the technical studies that would typically include acceptance criteria and performance data.

To answer your request, I would need access to the actual 510(k) submission document (not just the FDA's decision letter), which would contain the performance testing results and study design.

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Use during mask ventilation to assist in the determination of a patent airway. Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.

Not Found

This document is a 510(k) clearance letter from the FDA for a device named "CO2 Easy," a Carbon Dioxide Gas Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices.

The provided text does not contain any information about acceptance criteria, device performance results, specific study methodologies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) summary report or other supporting documentation submitted to the FDA, not in the clearance letter itself.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory approval, not a scientific study report.

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