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The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.

1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user.
2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.
3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.

The AG100s system is comprised of the following main components:

• The AG100s control unit
• The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
  Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter.
  When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the AG ETT). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
  The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.

The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence of a modified medical device (AG100s) to a previously cleared predicate device. This type of document typically does not contain detailed acceptance criteria and performance data in the format of a clinical study report with specific statistical outcomes, sample sizes, and expert qualifications.

However, I can extract the types of performance evaluations mentioned and general statements about the device's functionality.

Based on the provided document, here is an attempt to address your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the modified device (AG100s) functions equivalently to its predicate. The "performance data" section lists the types of tests conducted to support this claim.

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

The document does not specify quantitative sample sizes (e.g., number of patients, number of devices) for any of the tests mentioned (Comparative AG100s Cuff pressure control + suction performance, Software System V&V Test, Usability Validation).

Regarding data provenance: The studies were conducted by Hospitech Respiration Ltd., which is based in Israel. The nature of the studies ("Comparative," "V&V Test," "Usability Validation") suggests they are prospective validation and verification tests conducted specifically for this submission, likely involving laboratory or simulated environments, and potentially human factors evaluations. There is no mention of retrospective clinical data from patients.

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

The document does not provide this information. Given the nature of the tests (performance, software V&V, usability), "ground truth" would likely be established by engineering specifications, validated test methods, and human factors validation protocols rather than expert consensus on medical images or diagnoses. For usability, experts in human factors might be involved, but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Adjudication is typically used in clinical studies when there's uncertainty in ground truth or to resolve discrepancies among multiple readers. For the verification and validation tests described, results would likely be directly compared against predefined engineering specifications or performance metrics rather than requiring adjudication.

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

No, an MRMC comparative effectiveness study was not reported. MRMC studies are typically clinical studies evaluating the performance of AI-assisted human readers compared to unassisted readers, especially in diagnostic imaging. This document describes technical verification and validation studies to demonstrate substantial equivalence of a physical medical device.

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

The device itself is an automated system for monitoring and controlling cuff pressures and evacuating secretions. Its core function is inherently "standalone" in that it performs these tasks without immediate human intervention for each action, although it is designed for use by trained medical professionals who would set initial parameters and manage the patient. The performance tests described (cuff pressure control, suction performance, CO2 monitoring functionality, software V&V) inherently evaluate the device's standalone technical performance. There isn't a separate "algorithm only" evaluation as described for, for example, an AI diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests would be based on:

• Engineering Specifications: For parameters like cuff pressure control range (10-50 mmHg), suction pressure range (-20 to -120 mmHg), and flow rate (0-12 L/min).
• Validated Test Methods: Using calibrated equipment to measure and verify the device's outputs against its intended specifications.
• Functional Requirements: Demonstrating that features like CO2 monitoring leading to cuff pressure adjustment, and secretion evacuation, work as designed.
• User Needs/Human Factors Data: For the usability validation.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data in humans presented in this summary to establish ground truth.

8. The Sample Size for the Training Set

This document is for a modified physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here. The device's operation is governed by pre-programmed logic, not by a machine learning model trained on data.

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

As stated above, the concept of a "training set" is not applicable to this device.

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AG 100s is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

The AG100s system is comprised of the following main components:

• The AG100s control unit
• The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
• The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway.
• Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter.

AG100s, including its three components, monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user).

Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period.

The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

The provided text describes the Hospitech Respiration Ltd. AG100s device, an airway management system. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and reported device performance from a test set. Instead, it compares the characteristics of the AG100s system to its predicate device, the AnapnoGuard 100 System (K150157). The "Comparison" column in the table on pages 6-7 serves to highlight similarities and differences, and performance tests are mentioned to support substantial equivalence where differences exist.

Below is a summary of the performance-related comparison provided in the document:

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AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

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

Acceptance Criteria and Device Performance

The document describes several performance criteria derived from a comparison with predicate devices and specific performance bench tests. The clinical study primarily focuses on the effectiveness of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and reducing CO2 leakage.

Table 1: Acceptance Criteria and Reported Device Performance

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The AG MASSTM Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

The AG MASS™ is a sterile injection and draining device. The device is intended to deliver Saline fluid in order to dilute secretions accumulated above the cuff of an Endotracheal Tube and drain out all fluids. The AG MASS™ contains two syringes of 35 CC and 10 CC that are enclosed within MASS main body and is designed for use with Hospitech's AnapnoGuard ETT. The AG MASSTM is provided sterile for single use.

The provided document is a 510(k) summary for the AG MASS™ Suction Pump System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on bench testing. However, the document explicitly states that clinical studies were not required and therefore not performed to determine the safety and efficacy of the device.

As a result, I cannot provide the information requested regarding acceptance criteria and a study proving device performance in the context of clinical or comparative effectiveness studies with human readers. The information you are asking for, such as sample size, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document because such studies were not deemed necessary for this device's market clearance.

The document focuses on "Performance Bench Tests" and demonstrates compliance with relevant standards:

1. Table of acceptance criteria and reported device performance:

Based on the provided document, the "acceptance criteria" were primarily compliance with specific standards and successful completion of bench tests to demonstrate the device is "as safe and effective as the cleared predicate devices."

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

• Sample Size: Not applicable. The document states, "Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device." Performance was demonstrated through bench testing, not a clinical test set with a patient sample size.
• Data Provenance: Not applicable for clinical data. The data provenance described relates to engineering bench tests.

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

• Not applicable. Ground truth as typically understood for medical imaging or AI performance (e.g., radiologist consensus) was not established because clinical trials were not performed. The "ground truth" for the bench tests would have been engineering specifications and compliance with standards.

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

• Not applicable. No clinical test set requiring human adjudication was utilized.

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 comparative effectiveness study was not conducted. This device is a mechanical suction system, not an AI or imaging diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a physical medical device (suction pump system), not an algorithm or software. Its performance is inherent to its mechanical function, not an algorithmic output.

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

• For the bench tests, the "ground truth" was compliance with established engineering standards (e.g., ISO for sterilization and biocompatibility) and successful demonstration of the physical functionalities (e.g., draining validation). There was no clinical ground truth (like pathology or outcomes data) established as no clinical studies were performed.

8. The sample size for the training set:

• Not applicable. This device is a mechanical product, not an AI model that requires a training set.

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

• Not applicable, as no training set was used.

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The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways).

The Hospitech AG Cuffill is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.

The AG Cuffill is a disposable hand held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheotomy and LMAs tubes. AG Cuffill is configured as a syringe and consists of a sensitive pressure gauge embedded within the syringe plunger. AG Cuffill is battery powered. AG Cuffill is intended for one patient; it is limited to 100 operations and can be cleaned with disinfectant.

Here's an analysis of the provided text regarding the AG Cuffill device's acceptance criteria and study findings:

Acceptance Criteria and Device Performance Study for Hospitech AG Cuffill

The Hospitech AG Cuffill is a disposable, hand-held device designed to measure and manually regulate intra-cuff pressure of endotracheal, tracheotomy, and Laryngeal Mask Airway (LMA) tubes. The device's performance was evaluated through non-clinical testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

Note: The document specifies that "AG Cuffill accuracy is within its specifications and is better than the Posey Cufflator." This implies that "better than" the predicate is a form of acceptance criterion, or at least a favorable outcome.

2. Sample Size and Data Provenance for Test Set

The document is a 510(k) summary for the AG Cuffill and primarily focuses on non-clinical performance testing. It does not describe a clinical study with a "test set" in the context of patient data. Instead, it refers to tests conducted on the device itself.

• Sample Size for Test Set: Not applicable in the context of human subjects or patient data. The tests were performed on the device.
• Data Provenance: Not applicable in the context of human subjects or patient data (e.g., country of origin, retrospective/prospective). The data originated from internal performance testing conducted by the manufacturer, Hospitech Respiration Ltd.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for the device's performance (e.g., accuracy against a known standard) would have been established through calibrated reference instruments and defined specifications, not expert interpretation of patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. Device performance tests rely on objective measurements against pre-defined specifications or calibrated reference standards, not on adjudication of subjective interpretations.

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

• Was an MRMC study done? No. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Algorithm Performance Study

• Was a standalone study done? Yes, in a sense, as the performance tests listed are for the device's inherent functionality. The "Accuracy Verification Performance Test" and "Comparison Test with predicate device" provide standalone performance data for the AG Cuffill as a device, showing its accuracy (within ±1 mmHg) and comparison to a predicate.

7. Type of Ground Truth Used

The ground truth for the stated performance metrics was established through device specifications and calibrated measurement standards. For example, the accuracy was determined by comparing the AG Cuffill's readings against a precise, calibrated pressure measuring system across different pressure ranges. The "Comparison Test with predicate device" used the predicate device's measured performance as a comparative 'ground truth' or benchmark.

8. Sample Size for Training Set

The document does not describe a machine learning algorithm that requires a "training set." Therefore, information on a training set sample size is not applicable.

9. How Ground Truth for Training Set Was Established

As there is no mention of a training set for a machine learning algorithm, this is not applicable. The device's functionality is based on direct physical measurement, not on AI algorithms trained on data.

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The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.

The AnapnoGuard™ Endotracheal Tube is a sterile, single-use device supplied with main lumen with a standard 15mm connector. Four lumens are embedded within tube walls. One is a standard lumen used for the inflation/deflation of the cuff. Two suction lumens are embedded in the dorsal side of the tube having spatially unified into one success above the cuff. The two suction lumens are unified into one external lumen. These lumens are used to evacuate secretions that accumulate above the cuff. A forth lumen is embedded on the ventral side of the tube having an inlet port above the cuff. It is used for a) venting the subglottis space during suction to avoid vacuum b) for saline (or other fluid) rinsing above the cuff to dilute the secretions and ease the suction c) for air sampling above the cuff to detect leakage of air from the lungs past the cuff. The AnapnoGuard ETT is comprised of the following components: Main lumen (PVC or Silicone), Cuff (Polyurethane for PVC tube and Silicone for Silicon tube), Cuff inflate/deflate lumen, Two suction lumens combined into one outside of the tube sealed with a cap, Venting/air and CO2 sampling lumen sealed with a cap, Murphy eye (with or without).

The provided text describes the AnapnoGuard™ Endotracheal Tube and its substantial equivalence to predicate devices, thus demonstrating its safety and effectiveness. However, it does not contain specific acceptance criteria, a table of acceptance criteria vs. reported device performance, or detailed information about the studies that would allow for a complete answer to your request. The document focuses on regulatory compliance through substantial equivalence, which often relies on comparative analysis with existing, cleared devices rather than a new standalone clinical study with predefined acceptance criteria.

Therefore, I can extract and infer some information, but a complete table of acceptance criteria and device performance, as well as detailed study information, cannot be fully provided from the given text.

Here is what can be inferred and explicitly stated from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a table comparing them to reported device performance. Instead, it relies on demonstrating compliance with established standards and substantial equivalence to predicate devices. The "reported device performance" is summarized as being "as safe and effective as the cleared predicate devices" and that "no occlusion or any adverse events occurred during the study, airway stay open throughout study procedure."

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

• Sample Size:
  • Pre-clinical study: 6 goats.
  • Bench Tests: The sample sizes for each specific bench test (e.g., number of tubes tested for cuff resting diameter) are not provided.
• Data Provenance: The preclinical study was conducted by Hospitech Respiration Ltd. The location of the animal study (e.g., country) is not specified. The study is referred to as "preclinical," which implies a prospective study in an animal model.

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 preclinical animal study, the "ground truth" would likely be established by veterinary specialists or researchers involved in the study, observing the animals and collecting physiological data. However, the document does not mention the number or qualifications of experts for this specific purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not done. The document states, "Due to the pre-clinical study performed with the AnapnoGuard ETT device, the thorough performance tests and comprehensive clinical study performed by the cleared predicate device (Attachment No. 9), Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device." This indicates reliance on predicate device data and preclinical/bench testing for the AnapnoGuard ETT, not a human reader study.

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

This question is not applicable as the device is a physical medical device (endotracheal tube), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the preclinical study: Observational data from animal intubation (e.g., "no occlusion or any adverse events occurred," "airway stay open"). This would be considered outcome data within the context of the animal model.
• For bench tests: Measurements against established physical and performance standards (e.g., cuff diameter measurements, resistance tests). This is objective measurement data compared to specifications.
• For substantial equivalence: Comparison against the characteristics and performance of the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device, not an AI model that requires a training set.

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

This question is not applicable as the device is a physical medical device, not an AI model.

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