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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."

The reported performance for the Besmed CO2 Monitoring Line demonstrates lower resistance to flow compared to the predicate device, which is considered favorable. Leakage performance is equivalent. Other attributes are either identical or functionally equivalent.

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

The document mentions "a number of tests" were performed for "comparative resistance to flow" and "pre and post-exposure" for age and environmental testing. However, specific sample sizes for these tests are not provided in the summary. The provenance of this data is from the manufacturer's internal testing as part of their 510(k) submission, likely performed in Taiwan where the manufacturer is located, but this is not explicitly stated as "country of origin for data." All testing appears to be retrospective bench testing on manufactured units.

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

Not applicable. This device is a fluidic component, not an AI or diagnostic device that requires expert interpretation for a ground truth. The "ground truth" for its performance is derived from direct physical measurements (e.g., flow resistance, leakage).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described or required for this type of bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI devices where human readers interpret cases. The device in question is a CO2 monitoring line, an accessory to a gas monitoring system, and its performance is evaluated through bench tests, not human interpretation.

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

This question is not applicable to a non-AI medical device. The device's performance is inherently "standalone" in the sense that it's the physical tubing and filter, and its function is measured directly, not through an algorithm.

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

The "ground truth" for this device's performance is based on direct physical measurements and engineering standards, such as ISO 594-2 for luer fittings and internal manufacturer specifications for resistance to flow and leakage. The comparison is against the performance of a legally marketed predicate device, with the implication that the predicate's performance serves as an acceptable benchmark.

8. The sample size for the training set

Not applicable. This is not an AI device, so 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 this is not an AI device, there is no training set or ground truth in the context of machine learning.

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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

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

The document does not explicitly state a specific numerical sample size for the test set used for accuracy or other performance testing. It simply refers to "a number of tests."

• Data Provenance: The document does not specify the country of origin of the data. It implies the testing was conducted by or for Besmed Health Business Corp., which is located in New Taipei City, Taiwan. The studies were likely prospective as they were conducted to demonstrate the device's performance against defined criteria.

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

This information is not provided in the document. For a device like a pressure manometer, the "ground truth" for accuracy testing would typically be established by a highly accurate reference pressure measurement system or calibrated standard, not by human experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As the "ground truth" for pressure measurements is established by a reference instrument, an adjudication method involving human experts is not relevant for this type of objective performance testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a measurement tool, not an interpretive one.

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

This device does not contain an algorithm in the sense of AI. It is a mechanical device. The performance testing described ("Accuracy of pressure across the full pressure range") essentially is a standalone performance evaluation of the device's ability to measure pressure. There is no human-in-the-loop component for the measurement itself, only for the observation and interpretation of the displayed pressure by the clinician.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the accuracy testing, the ground truth was based on a reference pressure standard. The document states, "Accuracy of pressure across the full pressure range to meet the pass / fail criteria." This implies the device's readings were compared against a known, precise pressure source.

8. The Sample Size for the Training Set

This information is not applicable. This device is a mechanical manometer, not an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for a mechanical device.

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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.

Self-correction: The document explicitly states "Particle size < 5 micron" for both the predicate and new device under "Comparison Areas" as a "Similar" characteristic. This serves as an acceptance criterion implicitly met by the new device.

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

• Sample Size for Test Set: Not applicable in the context of diagnostic AI algorithms. The studies mentioned (Nebulizer Characterization, Biocompatibility) would have their own sample sizes for parts or materials, but these are not specified in the summary.
• Data Provenance: Not applicable in the context of diagnostic AI algorithms as no "data" in that sense is being analyzed. The device is manufactured by Besmed Health Business Corp. in Taiwan. The testing would likely be performed in a controlled laboratory setting.

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

Not applicable. This device is a medical accessory, not a diagnostic AI intended to interpret medical images or data requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the performance and biocompatibility testing of a nebulizer.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the performance of diagnostic systems (often AI-assisted) and human readers. The BESMED Jet Nebulizer is a device for drug delivery, not diagnosis.

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

No, a standalone study (in the context of an AI algorithm) was not done. An AI algorithm is not part of this device. The studies mentioned are performance tests of the physical nebulizer.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be established through objective measurements against defined engineering specifications and regulatory standards. For example:

• Nebulizer Characterization: Measurements of aerosol particle size distribution, nebulization rate, and drug output, compared to the requirements of USFDA 21CFR part 58 and, implicitly, demonstrating equivalence to the predicate device.
• Biocompatibility: Laboratory testing (cytotoxicity, skin irritation, sensitization) following ISO 10993 standards, where the "ground truth" is the biological response observed in the test systems against acceptance limits defined by the standard.

There's no clinical "ground truth" in terms of disease presence/absence or medical condition for this type of device.

8. Sample Size for the Training Set

Not applicable. There is no AI algorithm involved, so no training set is used.

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

Not applicable, as no training set is involved.

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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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Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: Relaxation of muscle spasms; Prevention or retardation of disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion. Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Besmed various models of Powered Muscle Stimulator, BE-560 / BE-580

This document is a 510(k) premarket notification decision letter from the FDA for a powered muscle stimulator. It does not contain the kind of information requested regarding acceptance criteria and a study proving device performance.

The letter states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device does not require a new premarket approval application (PMA) but can be marketed under general controls provisions.

The enclosed "INDICATIONS FOR USE STATEMENT" lists the intended uses of the device.

Therefore, I cannot provide the requested information from this document.

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