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The FloCHANNEL is intended for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. A filtered disposable nasal/oral cannula attaches to the patient and connects into the input of the FloCHANNEL device. The outputs of the device provide low-voltage signals that are intended to be input into a physiological recorder.

The FloCHANNEL device can be used for pediatric patients, two years and older and adult patients including geriatric patients. The device is not intended for pediatrics and infants below two years of age for the purpose of respiration or SIDS monitoring.

The FloCHANNEL, FC-100, Sleep Diagnostic Device accomplishes its intended purpose by providing a measure nasal airflow resistance effects. The device simultaneously measures relative airflow of isolated left, right, and oral passages. The FloCHANNEL, FC-100, provides analog voltage out hardware amplified analog voltages from three all now sensors, hardware analog voltages to aid in scoring the respiration of a patient. The outputs provided an have a summed output, and two microprocessor all now sensors, hardware analog voltages to aid in scoring the respiration of a patient.

The FloCHANNEL, FC-100, is dependent on the patient interface unit to be able to compute and detect the respiration patterns of the patient. This accessory is three air compute and delove the respirately pannula. The cannula is of one-piece construction that allows independent pneumatic fluid connection between the FloCHANNEL, FC-100, that the patient's left nasal airway, right nasal airway, and oral airway. The filter shall arra the patient of on habat all ways greater than or equal to 0.1 microns in size between prevent the transfer or partiountios groater and filter per channel on the patient interface unit with independently sealed chambers to prevent cross flow between pneumatic channels.

The FloCHANNEL has an output selection switch that is accessible from the outside of the enclosure and to a lour pockibility in the output options to be able to configure to a the switch to to ano it signal conditioners. With this switch there is the ability to create four different output voltage ranges.

There are six (6) output connectors on the FloCHANNEL, FC-100. All output connectors are Nort Julier. This re Nasal Processed Airflow, Oral Airway Processed Airflow, Sum r 10003500 Airflow and Right Nasal Processed Airflow, Relative Tidal Volume, and IE Marker.

The provided text does not contain specific acceptance criteria or a detailed study report with performance metrics. The document is a 510(k) summary for the Dormio Tech FloCHANNEL Model FC-100, focusing on demonstrating substantial equivalence to a predicate device.

However, I can extract the information requested as much as possible based on the available text, and note where information is not present.

Acceptance Criteria and Device Performance Study in 510(k) Summary for Dormio Tech FloCHANNEL Model FC-100

The provided 510(k) summary for the Dormio Tech FloCHANNEL Model FC-100 states that "The FloCHANNEL passed all of the tests and acceptance criteria as outlined in the test procedures. Test data demonstrates equivalence to the predicate device." However, the document does not explicitly define the specific acceptance criteria or provide the detailed reported device performance against those criteria. It focuses on claiming substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide quantitative acceptance criteria (e.g., specific accuracy thresholds, signal-to-noise ratios, or other performance specifications) nor does it provide quantitative performance data (e.g., specific numerical results from tests).

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document states "All risk assessment, design verification and validation activities were conducted in accordance with the device product requirements" and "The FloCHANNEL was proven clinically equivalent or superior to the predicate device." This suggests validation data was collected, but details on the nature (retrospective/prospective, country of origin, etc.) are absent.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned. The submission focuses on device equivalence, not human reader improvement with AI assistance. The device is a "Breathing Frequency Monitor" (ventilatory effort recorder), which typically involves direct physiological measurement rather than image interpretation by human readers.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: The device itself is a standalone hardware device that provides analog voltage outputs. "Standalone performance" in the context of an algorithm or AI is not applicable here as the device is a sensor and signal conditioner for direct physiological measurement, without embedded AI for interpretation. It outputs raw data ("low-voltage signals") to a physiological recorder for subsequent analysis by other systems or human experts.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. For a breathing frequency monitor, ground truth would typically refer to highly accurate reference measurements of airflow or ventilatory effort, likely from established medical equipment or gold-standard methodologies, which the device's output signals are compared against.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware sensor and signal conditioner, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

The Chad Therapeutics Bonsai a pneumatic-controlled device, which is a combination of r the Onad Therapoulator and an oxygen conserver, designed for use with ambulatory a low probute regulativers boluses of oxygen that is equivalent to 1 to 7 liters per minute, depending on the flow rate setting.

The provided text describes a 510(k) submission for the Chad Therapeutics Bonsai Model 800, which is a modified oxygen conserver. However, the document does not contain an acceptance criteria table or a study report detailing specific performance metrics against acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general statements about design verification and validation activities.

Therefore, many of the requested sections below cannot be populated from the provided text.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that "The Bonsai passed all of the test criteria established in the Bonsai design verification and validation tests." However, it does not provide a table with specific acceptance criteria or the reported performance data for each criterion. It only mentions one specific safety test the regulator passed.

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

This information is not provided in the document. The document only generally states "All risk assessment, design verification and validation activities were conducted in accordance with approved product requirements to demonstrate that the Chad Therapeutics Bonsai would perform as intended."

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)

This information is not applicable as this device is an oxygen conserver and the document describes engineering verification and validation, not studies requiring expert visual assessment or ground truth establishment in a medical imaging or diagnostic context.

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

This information is not applicable for the type of device and testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this device is an oxygen conserver and does not involve human readers interpreting images or data with or without AI assistance.

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

This information is not applicable as this is a mechanical medical device, not an algorithm or AI system.

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

For this type of device (oxygen conserver), "ground truth" would generally refer to established engineering standards, specifications, and physical measurements. The document implies that the "ground truth" for the tests involved verifying the device's performance against predefined "product requirements" and industry standards like ASTM G 175-03.

8. The sample size for the training set

This information is not applicable as this is a mechanical medical device, not an algorithm or AI system that requires a "training set."

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

This information is not applicable for the same reason as above.

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The Chad Therapeutics Lotus (modified Chad Therapeutics OXYMATIC Model 411) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as a portable oxygen delivery system for patients who require supplemental oxygen at flow rates equivalent to 1 to 6 liters per minute, in their home and for ambulatory use.

The Chad Therapeutics Lotus is a microprocessor-controlled device, which is a combination of a low-pressure regulator and an oxygen conserver, designed for use with a compressed oxygen source to provide a pulse of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.

This document is a 510(k) premarket notification for a medical device modification, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. A 510(k) submission, especially a "Special 510(k)," primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical trial to prove efficacy against acceptance criteria.

However, I can extract the information that is present and explain why certain information is not available in this type of document.

1. A table of acceptance criteria and the reported device performance

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

This information is not provided in this 510(k) submission. The testing described (ASTM, EMC, software compliance) involves engineering and bench testing, not typically a "test set" in the context of human data. There's no human subject data mentioned, so concepts like country of origin, retrospective/prospective, or sample size are not applicable here.

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)

This information is not applicable/provided. The testing performed is primarily technical and regulatory compliance (e.g., engineering standards, software standards). There is no mention of "ground truth" being established by medical experts for a diagnostic or interpretative purpose.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts are involved in interpreting data (e.g., radiology images). The tests described are bench tests and engineering compliance checks.

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

There was no MRMC comparative effectiveness study done. This is a special 510(k) for a device modification (oxygen conserver), and it does not involve AI or human interpretation of cases. The document focuses on demonstrating physical and software modifications maintain safety and effectiveness equivalent to the predicate device.

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

This is not applicable. The device is an oxygen conserver, a physical medical device, not an algorithm or AI system.

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

The "ground truth" in this context is based on engineering standards, safety standards (e.g., ASTM PS 127-00), and regulatory compliance specifications (e.g., EN 60601 for EMC, FDA guidance for software). These standards define the acceptable performance characteristics and safety profiles for the device. There's no biological or clinical "ground truth" derived from patient data mentioned.

8. The sample size for the training set

This is not applicable. The device is a hardware product with software; it is not a machine learning model that requires a "training set" of data in the AI sense.

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

This is not applicable for the same reason as point 8.

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The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.

The Chad Therapeutics Sage is a microprocessor-controlled device, which is a combination of a low-pressure regulator and a therapeutic oxygen device, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting and whether the user is at rest or active.

The provided 510(k) submission for the Chad Therapeutics Sage does not provide detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for AI/ML-based medical devices.

Instead, this submission is for a physical medical device (a non-continuous ventilator/oxygen conserver) and its acceptance criteria and "studies" are focused on demonstrating substantial equivalence to predicate devices through various types of engineering and performance testing.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not applicable or not provided in this type of submission:

Acceptance Criteria and Device Performance (Based on the document):

The document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) as would be the case for an AI/ML algorithm. Instead, the "acceptance criteria" are implied by demonstrating that the device performs as intended and is substantially equivalent to predicate devices.

Since this is a submission for a physical device, not an AI/ML algorithm, most of the specific questions regarding test sets, ground truth, experts, and AI-specific studies are not applicable (N/A) for this document.

Detailed Breakdown of Requested Information:

1. A table of acceptance criteria and the reported device performance:

   • See table above. The acceptance criteria are inferred from the device description and the claim of substantial equivalence, as specific performance metrics like sensitivity/specificity are not relevant for this type of device.

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

   • N/A. This device does not use a "test set" in the context of AI/ML data. The "testing" involved engineering and performance verification of the physical product, likely involving a limited number of physical prototypes or production units, not a dataset of patient information. The document does not specify the number of units tested.

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

   • N/A. Ground truth in the AI/ML sense (e.g., expert-labeled images) is not applicable here. The "ground truth" for a physical device is its adherence to engineering specifications and performance standards, verified through objective measurements and physical tests.

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

   • N/A. Not relevant.

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:

   • N/A. This is a physical oxygen delivery device, not a diagnostic or AI-assisted interpretation tool. MRMC studies are not applicable.

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

   • N/A. There is no standalone algorithm being evaluated in this submission. The device is a physical product.

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

   • The "ground truth" for this device's performance would be derived from objective engineering measurements, calibration standards, and validated test methods (e.g., precise oxygen flow meters, pressure gauges, electrical safety testers). These are not typically described as "ground truth" in regulatory summaries for physical devices.

8. The sample size for the training set:

   • N/A. This is not an AI/ML device; there is no "training set." The microprocessor controls are programmed based on engineering design and performance requirements.

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

   • N/A. Not applicable.

In summary: The provided 510(k) is for a hardware medical device (an oxygen conserver). The acceptance criteria are implicitly met by demonstrating that the device functions as described, meets safety standards, and is substantially equivalent to existing predicate devices. The "studies" involve various engineering, electrical, mechanical, and environmental tests, rather than clinical studies or AI/ML performance evaluations with specific datasets and ground truth.

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The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.

The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is a pneumaticcontrolled device, which is a combination of a low-pressure regulator and an oxygen conserver, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.

This document refers to a 510(k) premarket notification for a medical device called the "Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511," an oxygen conserver. The information provided is for regulatory clearance based on substantial equivalence, not a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from the provided text. This document is focused on regulatory clearance and substantial equivalence to predicate devices, not a clinical performance study with specific acceptance criteria as one might expect for a diagnostic or AI-driven device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" in the way one might for diagnostic accuracy (e.g., sensitivity, specificity, AUC thresholds). Instead, it relies on "substantial equivalence" to predicate devices and general performance, mechanical, and environmental testing.

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

This information is not provided in the document. The document mentions "Performance, mechanical and environmental testing" but does not detail the methodology, sample sizes, or data provenance for these tests. This is not a clinical study in the sense of a test set with patient data.

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)

This information is not applicable as this is not a study establishing a diagnostic ground truth or involving expert review of a test set for clinical performance. The evaluation is based on engineering and performance testing for regulatory clearance.

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

This information is not applicable as this is not a study requiring adjudication of expert opinions for a test set.

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

This information is not applicable. This device is an oxygen conserver, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or is relevant to this type of device.

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

This information is not applicable. This is a physical medical device (oxygen conserver), not an algorithm or AI system.

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

For the "testing" mentioned, the "ground truth" would be related to the device's technical specifications and intended function (e.g., ability to accurately deliver oxygen boluses at specified rates, durability under environmental conditions, safety criteria). However, the document does not specify the exact types of ground truth used for "Performance, mechanical and environmental testing." It likely refers to established engineering standards and specifications for oxygen delivery devices.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set.

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

This information is not applicable. This is not an AI/ML device that requires a training set.

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The intended use of the Chad Total O2 Delivery System is to supply low-pressure supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use. The oxygen supplied by the Total O2 Delivery System is supplemental and is not life supporting and not intended to be used with or for any life support applications or in the presence of flammable anesthetics.

The modified Chad Total O2™ Delivery System is intended for use in the same manner as the unmodified device: The Total O2™ Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

The Chad Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O2 Delivery System has been designed to reduce the need for built storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen gas cylinders for ambulatory use. The Total O2 Delivery System is comprised of conventional procedures and/or an integral pressure intensifier which supplies low pressure oxygen to a nasal cannula and/or an integral proposition of the oxygen gas cylinder for ambulatory use. The Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily, and safely connect to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O2 oxygen cylinders can only be filled by the Total O2 Delivery System. The Total O2 oxygen cylinders will be offered in two versions: 1. The original Total O2 cylinders with built in pressure reducer. 2. The Total O2 Post Valve cylinders with the same unique fill port as the original The Total O2, no built in pressure reducer but with a unique post valve outlet. The Total O2 post valve incorporates an internal mechanism to prevent filling the cylinders through the unique post valve port. Furthermore the Total O2 post valve would incorporate an index pin in the CGA V-1 number 13 position to prevent CGA-870 accordators, conserving devices, etc. from attaching to the unique post valve.

The provided document K013472 describes a Special 510(k) for the Modified Chad Total O₂™ Delivery System. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modification does not affect the device's indications for use or its fundamental scientific technology. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a full de novo study with extensive performance metrics against a predefined set of acceptance criteria.

Based on the provided text, the document states:

"Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended."

However, there are no specific acceptance criteria or detailed results of these tests provided in the document. The rationale for substantial equivalence primarily relies on the device having the "same technological characteristics" and the "hardware portion of the device is identical to the predicate device" with only modifications to the cylinder adapters and a unique post valve outlet for new cylinder types.

Since specific acceptance criteria and detailed study results are not present, much of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated from the provided text:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the document. For a Special 510(k), acceptance is typically based on demonstrating that the modifications do not alter the safety or effectiveness compared to the predicate device, often through bench testing validating specific changes.
• Reported Device Performance: The document only generically states that "Performance, mechanical, electrical, electromagnetic compatibility and r onomance, moshal (sic) testing was conducted to demonstrate that the Chad Total O₂ Delivery System would perform as intended." No specific performance metrics (e.g., flow rates, oxygen concentration, battery life, fill times, pressure retention) or their values are provided.

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

• Sample Size: Not specified. The testing mentioned appears to be bench testing on the device prototypes, not a clinical trial with human subjects.
• Data Provenance: Not specified, but implied to be internal testing conducted by Chad Therapeutics, Inc. (the manufacturer).

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 modified oxygen delivery system, and the testing described is technical/engineering performance testing, not a diagnostic or AI-driven system that requires expert ground truth for interpretation.

4. Adjudication method for the test set:

• Not applicable. As above, this type of testing (mechanical, electrical, performance) does not typically involve adjudication by experts in the way clinical diagnostic studies do.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study is not mentioned as this is not a diagnostic imaging device or an AI-assisted interpretation system requiring human reader comparison.

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

• Not applicable. This is a physical oxygen delivery device, not an algorithm.

7. The type of ground truth used:

• Not explicitly stated/applicable for this context. For mechanical and electrical performance, the "ground truth" would be engineering specifications and established standards for oxygen delivery systems. The document states testing was done to ensure the device "would perform as intended," implying comparison against these internal specifications and safety standards for the device type.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. This device does not involve a "training set" in the context of machine learning.

In summary, the provided document is a regulatory submission for a device modification, focusing on demonstrating equivalence to an existing predicate device rather than detailing a comprehensive new product validation study with specific acceptance criteria and performance data. The "Summary of Testing" section is very brief and high-level, indicating only that various types of engineering tests were conducted without providing any specific results or acceptance thresholds.

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The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

Not Found

This document is an FDA 510(k) clearance letter for the Chad TOTAL O2™ Delivery System. It primarily addresses the regulatory approval of the device and does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance.

The letter only includes:

• Device Name: Chad TOTAL O2™ Delivery System
• Indication for Use: "Supplemental Medical Oxygen for treatment of Respiratory Diseases."
• Regulatory Class: II
• Product Code: 73 CAW
• 510(k) Number: K971889

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification/validation report, or the actual study report submitted to the FDA for review. These documents typically contain the detailed information about performance criteria, study design, sample sizes, and ground truth establishment.

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