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Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Besmed HMEF

The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml.

Besmed Bacterial Filter

Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.

The provided text describes the acceptance criteria and the results of non-clinical testing for the "Besmed Bacterial Filter and HMEF." This summary focuses on the non-clinical test results, as no clinical testing was performed or required.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a set of predetermined acceptance criteria across various standards. The table below summarizes these criteria and the reported results.

Study Details

The provided document describes a non-clinical testing summary to support the substantial equivalence of the "Besmed Bacterial Filter and HMEF."

1. Sample Size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices) used for each individual test. The data provenance is implied to be from internal testing conducted by Besmed Health Business Corp., likely in Taiwan (New Taipei City, Taiwan is their address). The nature of the tests (performance, packaging, biocompatibility) indicates that these were prospective evaluations of manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as the studies are non-clinical, laboratory-based tests against established international and ASTM standards. Ground truth would be defined by the criteria within these standards, which are met if the device passes the specified thresholds. No human expert consensus for "ground truth" in clinical interpretation is relevant here.

3. Adjudication method for the test set: Not applicable for non-clinical, objective laboratory tests against defined standards.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable as the device is a physical medical device (breathing circuit bacterial filter and HMEF), not an AI-powered diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests is based on the acceptance criteria defined by international standards (ISO) and ASTM standards. These standards provide objective, measurable thresholds for performance, safety, and biocompatibility.

7. The sample size for the training set: This is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established: This is not applicable for the same reason as above.

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The intended device measures a patient's peak expiratory flow rate liters/minute.

The Besmed Peak Flow Meter is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The proposed device can be used to measure PEF by tracking day-to-day changes in breathing patterns.

The provided document is a 510(k) Summary for the Besmed Peak Flow Meter, seeking clearance from the FDA. It details the device's characteristics, indications for use, and a comparison to a predicate device, as well as non-clinical testing performed to demonstrate substantial equivalence.

However, this document does NOT contain information about an AI/ML-driven medical device, nor does it describe a study involving human readers, ground truth consensus, training sets, or comparative effectiveness with AI assistance.

The device in question, the Besmed Peak Flow Meter, is a mechanical, hand-held device for measuring peak expiratory flow. The performance testing discussed relates to device accuracy, repeatability, and physical durability (e.g., aging, drop test), which are standard for such mechanical instruments.

Therefore, I cannot extract the information required by your prompt because the document does not pertain to the type of device or study you are asking about (i.e., an AI/ML device study with human-in-the-loop analysis).

To answer your request, I would need a document describing the clearance or approval of an AI/ML medical device, which would include details about its acceptance criteria, ground truth establishment, training and test data, and potentially human reader studies.

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Single patient use positive end expiratory pressure (PEEP) valve for use in hospital, transport, emergency, and post hospital care settings to evaluate end lung pressure above atmospheric pressure at the end of exhalation in constant and intermittent gas flow conditions.

Not Found

This is a 510(k) clearance letter for the Besmed PEEP Valve, a medical device. These letters indicate that the FDA has found the device to be substantially equivalent to a predicate device already on the market. They typically do not contain detailed information about the acceptance criteria and the comprehensive study results in the way one might expect for a research paper or a PMA application.

However, based on the context of a 510(k) and the information provided, I can infer some aspects and highlight what is not present.

Acceptance Criteria and Device Performance for Besmed PEEP Valve (K160112)

Given that this is a 510(k) premarket notification, the "acceptance criteria" primarily refer to the FDA's determination of substantial equivalence to a predicate device, rather than specific performance metrics against a defined clinical endpoint. The submission would have included performance data to demonstrate this equivalence. The letter itself does not detail the specific acceptance criteria values or the reported device performance values but confirms that the device was found substantially equivalent based on the provided data.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is the FDA's clearance letter. It does not include the detailed performance data or the specific acceptance criteria (e.g., "PEEP variability must be within +/- X cmH2O") that were part of the original 510(k) submission. For that level of detail, one would need to access the full 510(k) summary, if publicly available, or the internal submission documents.

Study Information (Based on general 510(k) requirements and inferences):

For a device like a PEEP valve, the "study" would typically involve non-clinical (bench) testing to demonstrate the valve's ability to maintain specified PEEP levels under various flow conditions and over time, as well as biocompatibility testing. Clinical studies are generally not required for Class II devices seeking 510(k) clearance unless there are new or significantly different indications for use or technology.

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

• Sample Size: Not specified in the clearance letter. For bench testing, this would refer to the number of devices tested. It is often a statistically relevant sample size to ensure reproducibility and reliability of the performance data.
• Data Provenance: Not specified, but likely from the manufacturer's internal testing facilities or a contracted testing lab. Given the manufacturer's location, the testing could be international (e.g., Taiwan, where Besmed is located) or in the US. The letter itself does not mention retrospective or prospective data, but bench testing is generally performed prospectively to gather specific performance characteristics.

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

• This question typically applies to studies involving human interpretation (e.g., imaging studies). For a mechanical device like a PEEP valve, "ground truth" is established by physical measurements and engineering standards, not expert consensus in the same way. The "experts" would be engineers and technicians performing the tests, adhering to established test protocols and using calibrated equipment. Their qualifications would involve expertise in medical device testing, respiratory mechanics, and relevant regulatory standards. The number of such individuals involved in test design, execution, and data analysis would vary but is not individually enumerated.

4. Adjudication method for the test set:

• Again, this generally applies to scenarios with subjective human interpretation. For bench testing of a PEEP valve, objective measurement against predefined specifications is the primary "adjudication." Any discrepancies in measurements (e.g., between multiple test runs or different equipment) would be resolved through review of calibration records, re-testing, or technical investigation, not through a consensus panel in the sense of clinical 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:

• No. An MRMC study is completely irrelevant for a PEEP valve. This type of study is specific to diagnostic imaging devices or AI-driven decision support tools where human interpretation of medical images or data is involved. The Besmed PEEP Valve is a mechanical breathing attachment; it does not involve AI or human "readers" in its function or evaluation for substantial equivalence.

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

• No. This is also irrelevant. This question pertains to AI/software as a medical device (SaMD) where algorithms perform tasks without direct human intervention. The Besmed PEEP Valve is a hardware device; it does not contain an algorithm in this context.

7. The type of ground truth used:

• For a PEEP valve, the ground truth is based on objective physical measurements against established engineering specifications and recognized consensus standards (e.g., ISO standards for respiratory equipment). This would include measurements of:
  • Pressure control/accuracy (e.g., maintaining a set PEEP +/- tolerance).
  • Flow resistance.
  • Leakage.
  • Durability.
  • Biocompatibility (through laboratory testing of materials).

8. The sample size for the training set:

• Not applicable. The concept of a "training set" applies to machine learning/AI models. A PEEP valve is a mechanical device, not an AI model, and therefore does not have a training set.

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

• Not applicable. As above, there is no training set for a mechanical PEEP valve.

In summary, the provided FDA clearance letter attests to the Besmed PEEP Valve's substantial equivalence to a predicate device, based on a comprehensive 510(k) submission that would have included detailed bench testing and engineering data. However, the letter itself does not provide these detailed technical specifications or study results, and many of the questions (especially those related to AI, human readers, and clinical studies) are not pertinent to this type of device and regulatory submission.

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The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.

The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient.

This document is an FDA 510(k) clearance letter for the Besmed Reusable Jet Nebulizer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the technical performance testing of the device against specific acceptance criteria.

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CO2 Monitoring Lines are intended to connect from a CO2 sampling port to the expired gas monitor.

The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas sampling equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.

The provided text describes a 510(k) premarket notification for a medical device called "Besmed CO2 Monitoring Line With and Without In-Line Filter." This document does not pertain to an Artificial Intelligence (AI) device, but rather a passive medical accessory. As such, many of the requested categories related to AI device evaluation (such as sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable or a study as described would not have been performed.

However, I can extract the acceptance criteria and performance data provided for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the proposed device's performance to that of a legally marketed predicate device (K122075 – Intersurgical – CO2 Monitoring Line). The goal is to demonstrate "equivalent performance."

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The Besmed Volumetric Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.

The Besmed Volumetric Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a ball and piston which upon the patient inhaling, creates a vacuum, which causes the ball and piston to rise, the piston reflects the inspiratory volume while the ball is an indicator for the user to maintain the optimum inspiratory flow rate. Two (2) models are offered - 2500 cc and 5000 cc. It is a single patient, multi-use, disposable, non-sterile device. The mouthpiece may be removed and cleaned by the user as needed but the main device is not to be cleaned.

As a patient improves their respiratory capacity or gets stronger they improve their inspiratory volume raising the piston. The principle of the ball indicator is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers".

The Besmed Volumetric ICS achieves the therapeutic intent by helping the patient to improve their inspiratory volume. It is a relative improvement device that as described offers the patient the "incentive" to improve. This is the identical therapeutic intent of the predicate volume based incentive spirometer.

The provided document describes the 510(k) premarket notification for the "Besmed Volumetric Incentive Spirometer." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study proving device acceptance criteria in the context of diagnostic accuracy or comparative effectiveness with human readers.

Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable to the information contained within this 510(k) summary. This document primarily details non-clinical performance and comparisons to a predicate device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are derived from the observed performance of the proposed device and are compared to the predicate's (Hudson RCI K801199), which reported an accuracy of ~21%. The Besmed device's performance is stated as "equivalent (or better)."

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

The document states: "Multiple samples of each device were tested multiple times and then evaluated for consistency of performance." However, specific sample sizes (number of devices, number of tests per device) for the non-clinical performance evaluation are not explicitly provided.

Data provenance: Non-clinical testing appears to have been conducted by the manufacturer, Besmed Health Business Corp. The country of origin of the data is not explicitly stated beyond the manufacturer's location (Taiwan). It is a retrospective analysis of device performance against internal specifications and comparison to a predicate device.

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

Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.

4. Adjudication method for the test set

Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.

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 document describes a physical medical device (incentive spirometer), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a physical medical device; there is no "algorithm only" performance separate from the device's inherent mechanical function.

7. The type of ground truth used

For volume accuracy, the ground truth would be the accurately measured volume of air moved by a calibrated testing system.

For age testing and environmental testing, the ground truth is the "performance specifications" that the device is expected to meet both before and after exposure to certain conditions.

8. The sample size for the training set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

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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 Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.

The Besmed TriBall Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a series of balls which upon the patient inhaling, creates a vacuum, which causes the balls to rise, they reflect the inspiratory flow rate in cc/sec (600, 900 and 1200). It is a single patient, multi-use, disposable, non-sterile device. As a patient improves their respiratory capacity or gets stronger their inspiratory flow rate raises the balls. The principle is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers". The TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate. It is a relative improvement device that as described offers the "incentive" to improve. This is the identical therapeutic intent of all predicate flow / volume based incentive spirometers.

The provided text describes the 510(k) summary for the Besmed TriBall Incentive Spirometer. I will extract the requested information based on the content.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states, "Multiple samples of each device were tested multiple times." However, specific numerical sample sizes for devices or tests, or data provenance (country of origin, retrospective/prospective) are not provided.

2. 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):
   This device is a physical medical device (incentive spirometer), not an imaging or diagnostic AI-driven device that typically requires expert-established ground truth. Therefore, this information is not applicable and not provided in the document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as this is a performance test for a physical device, not an assessment requiring expert adjudication of data. The performance was measured directly against technical specifications.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool involving human readers/interpreters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The "performance testing" described is for the physical device itself, in terms of its inspiratory rate/volume accuracy, and its ability to withstand environmental conditions, not for an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for the performance testing of the incentive spirometer was based on pre-defined technical specifications for inspiratory rate/volume accuracy (+/- 5%) and the ability to maintain performance after environmental stressors. This is a direct measurement against engineering and design standards, not a clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:
   Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for the physical product’s performance characteristics.

8. 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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The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.

The information provided describes the acceptance criteria and a study to demonstrate substantial equivalence for the BESMED Jet Nebulizer Bottle Set, Model PN-1128E, as part of a 510(k) submission.

This is a device for administering aerosol treatments. The studies conducted are primarily performance and biocompatibility tests, rather than studies involving human readers or AI algorithms for diagnostic purposes. Therefore, some of the requested information (like MRMC studies, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets in the context of AI) is not applicable to this type of device and submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance beyond what's compared with the predicate device. However, it indicates conformity to relevant standards and a comparative analysis.

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• Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
• Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

Besmed various models of TENS, BE-550 / BE-660

The provided text is an FDA 510(k) clearance letter for Besmed various models of TENS, BE-550 / BE-660. The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, this document does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or details about any studies (standalone, MRMC, or otherwise) that would "prove the device meets the acceptance criteria."

The clearance is based on substantial equivalence to a predicate device, as explicitly stated: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.

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