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The Sunrise Medical Quickie Rhythm Powered Wheelchairs intended use is to provide mobility to persons limited to a seating position that have the capability of operating a powered wheelchair. The Quickie Rhythm Power Wheelchairs provide an optional means of mobility for physically challenged people.

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This document is a 510(k) clearance letter from the FDA for a powered wheelchair, not a study evaluating a medical device's performance against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

The letter simply states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain any performance data or study results.

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The DeVilbiss Sleep Recorder is intended for screening patients suspected of or exhibitina symptoms of sleep disorders. The DeVilbiss Sleep Recorder can be used with an autotitrating CPAP to record the results of CPAP treatment for adults diagnosed with sleep apnea syndrome. Patients suffering from excessive daytime sleepiness should be referred to a sleep disorder specialist. The results of an unattended screening are insufficient to identify all possible medical disorders that may produce these symptoms. This device is intended to aid the physician in diagnosing adult sleep apnea. A qualified medical professional should score the device's recorded signals to determine respiratory events.

The DeVilbiss Sleep Recorder consists of a main control box, a chest mounted interface box and several sensors mounted to the patient. The main control box contains a Novametrix oximeter board, the microcontroller and memory board, four AA battery compartment and connectors for external devices. The main control box is intended to be placed on a night stand or near the patient's bed. A chest mounted interface box containing body position sensors and connections for a nasal thermistor, a nasal cannula, snore microphone and three ECG leads is attached to the patient. The sensors used for a standard diagnostic recording are: 1. ECG leads (3) 2. Snore Microphone 3. Nasal Thermistor or Nasal Cannula 4. Oximeter Probe 5. Body Position sensor (inside chest box)

Here's an analysis of the provided text regarding the DeVilbiss Sleep Recorder (K012437) in relation to acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, explicit quantitative acceptance criteria for device performance are not detailed. The summary states the device's performance tests and clinical trials demonstrated "substantial equivalence to the predicate devices based on types of sensors, battery operation, real time monitoring, presentation and analysis of the recorded data and intended use." It also mentions "tests confirming accuracy of the recorded data to the product specifications and the conformance to electrical standards applied for a Class II Type CF device."

Without specific numerical targets for accuracy, sensitivity, specificity, or agreement with a reference standard, a table of "acceptance criteria" versus "reported performance" cannot be fully constructed.

However, the reported demonstration of performance is that the device achieved substantial equivalence to its predicate devices (Bio-Logic Sleep Scan K962103 and Nellcor Puritan Bennett (Melville) Ltd. Sandman Sleep Data Storage System K934599) through performance tests and clinical trials. This substantial equivalence is the de facto "acceptance" based on the FDA's 510(k) pathway.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "performance tests and clinical trials" without specifying the number of participants or cases involved in these studies.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to generally as "performance tests and clinical trials." Given the submission is to the US FDA, it is highly probable the data was generated or is applicable to the US market, but no specific geographic origin is provided.
• Retrospective or Prospective: Not explicitly stated.

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

• The document states: "A qualified medical professional should score the device's recorded signals to determine respiratory events." and "The information in the study is hand scored for respiratory events and used by a healthcare professional to determine if CPAP treatment is a preferred approach."
• Number of Experts: Not specified.
• Qualifications of Experts: "Qualified medical professional" and "healthcare professional." Specific qualifications (e.g., "radiologist with 10 years of experience" or "board-certified sleep physician") are not provided.

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

• Adjudication Method: Not specified. The phrase "hand scored for respiratory events" does not indicate any specific adjudication process if multiple scorers were involved.

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:

• MRMC Study: No. This device is an ambulatory sleep recorder that collects physiological signals. The analysis is "performed on one or more channels to determine SpO2 desaturations, heart rate shifts and Pulse Transit Time (PTT) shifts." There is no mention of "AI assistance" or comparative effectiveness studies involving human readers improving with or without AI. The device functions as a data collection tool, and a human scorer interprets its output.

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

• Standalone Study: The device is not intended for standalone diagnosis. The document explicitly states: "The information in the study is hand scored for respiratory events and used by a healthcare professional to determine if CPAP treatment is a preferred approach." and "A qualified medical professional should score the device's recorded signals to determine respiratory events." This signifies a human-in-the-loop process is mandatory for diagnosis. The device is a "portable recording system" that aids the physician.

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

• Type of Ground Truth: The ground truth for determining "respiratory events" is effectively expert scoring/interpretation by "a qualified medical professional" or "healthcare professional" based on the recorded signals. This is implicit in the statements regarding hand scoring and professional interpretation. There is no mention of a more objective ground truth like pathology or long-term outcomes data for direct correlation with the device's signal detection.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable/not stated. As described, this device is a physiological signal recorder. There is no mention of a machine learning or AI component that would require a distinct "training set" in the context of supervised learning algorithms. The device's "performance tests and clinical trials" would typically focus on the accuracy of its measurements against established standards or predicate devices, rather than training a diagnostic algorithm.

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

• Ground Truth for Training Set: Not applicable, as there's no evident training set for an AI/ML algorithm within the device description. The device's function is to record physiological data accurately. The "ground truth" for its validation would be the accuracy of these recorded signals against known benchmarks or the predicate device's signals, not a diagnostic classification that would typically be trained.

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The DeVilbiss PD1000 Compact Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate Joneer than they would with a continuous flow regulator on the same cylinder.

The DeVilbiss PD1000 compact conserving device is designed to extend the use time of oxygen cylinders. The device uses PulseDose technology to accomplish the oxygen savings. PulseDose senses the start of inhalation and instantly releases a short "pulsed" dose at the very beginning of the inhalation cycle. Since all of the "pulsed" oxygen finds its way deep into the lungs, less oxygen is required to accomplish the same effect than with traditional continuous flow oxygen systems.

The PD1000 compact conserving device contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. The PD1000 then delivers oxygen to the patient by sensing inhalation via a pressure switch and opening a two-way valve for a specified period of time controlled by a microprocessor. The unit is designed to deliver 16.5 cc/lpm of oxygen to the patient at 1.0. 1.5. 2.0, 2.5, 3.0, 4.0, 5.0 and 6.0 flow settings. The unit is powered by two "AA" alkaline or nickel metal hydride batteries. The PD1000 has a continuous flow back-up mode that will deliver 2 ipm continuous to the patient in the event of a device failure or dead batteries.

The device has two LED's that indicate battery status and valve activation. When the unit is first turned on, either a red or green LED will flash to indicate the unit is turned on and the battery status. Each time the valve is activated during an inhalation, the red or green LED will flash to indicate the valve was activated and the battery status. The device will operate approximately 4 -- 8 hours when the red LED first begins to flash. When the battery voltage drops below approximately 1.9 vdc the red LED will remain on continuously and the valve will no longer operate. The continuous flow back-up mode can still be used to provide oxygen therapy to the patient when the batteries are no longer able to operate the unit.

The ability of the PD1000 to detect patient inspirations is based on the sensitivity of the pressure switch which is set within a range of .1 to .25 cm H2O. The device is capable of delivering a bolus of oxygen at the beginning of each inhalation up to 40 breaths per minute (every 1.5 second minimum delay between breaths will cause the device to "skip" breaths at rates greater than 40 breaths per minute.

Here's an analysis of the provided text regarding the DeVilbiss PD1000 Oxygen Conserver and its acceptance criteria, focusing on the requested information:

Acceptance Criteria and Device Performance for DeVilbiss PD1000 Oxygen Conserver (K020329)

The submission for the DeVilbiss PD1000 primarily focuses on demonstrating substantial equivalence to its predicate device, the DeVilbiss EX2000 PulseDose Conserver, through technological characteristic comparisons and performance data. The core acceptance criteria revolve around matching the pulse volumes of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "The pulse volumes of the PD1000 were compared to the pulse volumes of the EX2000 predicate device. The pulse volume in cubic centimeters, valve "ON" time and waveform of the pulse volume or "bolus" was recorded for each setting of the PD1000. This data was also obtained for the same settings on the EX2000."

• Sample Size for Test Set: Not explicitly stated in terms of the number of unique device units tested or the number of measurements taken per unit. It refers to "each setting" and "same settings." However, given the nature of the device (mechanical/electronic), the sample size would likely refer to a representative number of manufactured units. Specific numbers are not provided.
• Data Provenance: The study appears to be an internal, prospective laboratory study conducted by the manufacturer, Sunrise Medical HHG, Inc., Respiratory Products Division, located in Somerset, PA, USA. There is no indication of external data sources or retrospective analysis of clinical patient data.

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

• Number of Experts: Not applicable. The "ground truth" for the performance data (pulse volumes, breath detection sensitivity, etc.) was established through direct measurement and comparison to the predicate device's performance, not through expert consensus on qualitative data.
• Qualifications of Experts: Not applicable. The performance data is quantitative and measured instrumentally.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "test set" involves direct technical measurements of physical characteristics (e.g., pulse volume, valve "ON" time, sensitivity). These are objective measurements and do not require human adjudication in the way that, for example, classifying medical images would.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study is a non-clinical, technical comparison of the new device's performance against a predicate device's measured performance in a laboratory setting.
• Effect Size: Not applicable, as no MRMC study was conducted. The study is focused on demonstrating technical equivalence rather than a clinical improvement over a human-in-the-loop process.

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

• Standalone Performance: Yes, the performance evaluation described is entirely standalone. The device (DeVilbiss PD1000) was tested intrinsically for its ability to produce specific pulse volumes and detect breath events, independent of a human operator influencing its core function during the test. There is no "human-in-the-loop" aspect to the technical performance measurements described.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is primarily objective, quantitative measurements of physical characteristics and performance parameters, directly observed and compared to the established performance of the legally marketed predicate device (DeVilbiss EX2000 PulseDose Conserver). In essence, the predicate device's performance served as the "ground truth" for the new device's expected performance. There is no mention of pathology, expert consensus, or outcomes data for this specific validation.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical/electronic oxygen conserver, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "programming" of the device involves fixed valve times programmed during assembly, not learned parameters from a data set.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set." The device's operational parameters (e.g., fixed valve times) are pre-programmed based on engineering design and prior knowledge from the predicate device, not established through an iterative training process with a ground truth dataset.

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The DeVilbiss Heated Humidifier System, consisting of the 9100D DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry.

The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode when used with the 9200 heated humidifier system. The heated humidifier system may adversely affect the operation of certain CPAP machines that have automated pressure setting.

The DeVilbiss Heated Humidifier System is for use in the home environment and is to be used only on the order of a physician. The humidifier can be used with CPAP and Bilevel devices, which have a maximum operating pressure of 20 cm H20. The humidifier can also be used with noninvasive ventilation devices that have a maximum operating pressure of 40 cmH20.

Model 9200D Heated Humidifier

The provided text is a 510(k) premarket notification letter from the FDA to Sunrise Medical HHG, Inc. regarding the DeVilbiss Model 9200D Heated Humidifier. It does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria for an AI/ML device.

The document is a regulatory approval letter stating that the device is "substantially equivalent" to legally marketed predicate devices. It discusses the device's indications for use and regulatory classification, but not performance metrics or study designs for validating AI/ML software.

Therefore, I cannot provide the requested information based on the given text. The text does not describe an AI/ML device or its associated studies and acceptance criteria.

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The system is used on the order of a physician for the treatment of asthma, bronchitis and other respiratory diseases. The nebulizer converts the liquid medication into a fine aerosol mist which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patients airway.

The Sunrise Medical Model 800 Series jet nebulizer is a reusable hand held, small volume jet nebulizer. The nebulizer is designed for use in conjunction with a compressed gas source such as the Sunrise Medical Pulmo-Aide Model 5650 Compressor (FDA 510(k) Registration # K923888), Sunrise Medical Pulmo-Mate Model 4650 Compressor (FDA 510(k) Registration # K931015) or Sunrise Medical Pulmo-Aide LT Model 3650 Compressor (FDA 510(k) Registration # K970289). The nebulizer & compressor system is used on the order of a physician to treat various respiratory problems. The nebulizer converts the liquid medication into a fine aerosol mist, which can be inhaled for home respiratory therapy. This allows the medication to be deposited at the affected areas of the patient's airway. The Sunrise Medical Model 800 Series iet nebulizer is designed to offer high respirable aerosol output for the patient. The nebulizer is intended as a long term usage nebulizer (approximately 1 year) similar to other reusable nebulizers that are currently being marketed by competitors of Sunrise Medical such as the Pari LC Plus and Pari Jet permanent nebulizers manufactured by Pari of Germany and distributed here in the U.S. Accessories include a triggering system to shut off airflow to the nebulizer to conserve medication between breaths.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KG93492 medical device submission:

Based on the provided 510(k) summary for the Sunrise Medical Model 800 Nebulizer (KG93492), the information is very limited regarding specific acceptance criteria and detailed study performance data. This document is a summary provided for FDA clearance of a Class II device, which often focuses on substantial equivalence to predicate devices rather than extensive clinical trials with detailed performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format often seen for software or AI-based devices. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Sunrise Medical Model 700, Pari LC Plus, Pari Jet).

The key performance claims are related to:

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

The document does not specify a sample size for a "test set" in the context of clinical or performance testing. The statement "Testing performed on the aerosol output and particle size..." indicates that some form of testing was done, but details regarding the number of devices tested, number of measurement cycles, or the specific methodology are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

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

This information is not provided. Given that this is a 510(k) for a medical device (nebulizer) and not an AI/software device, the concept of "ground truth" and expert adjudication in the manner typically discussed for diagnostic algorithms is generally not applicable here. Performance is measured against physical metrics (aerosol output, particle size) rather than expert interpretation of data.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not relevant or described for this type of device submission. Performance is measured objectively rather than through expert consensus on qualitative outcomes.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools to assess how human readers' performance (e.g., accuracy, speed) is affected by AI assistance. A nebulizer is a therapeutic device, not a diagnostic one.

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

Not applicable. This device is a physical, mechanical nebulizer, not an algorithm or software. Its performance is inherent to its design and function, not an "algorithm only" performance.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the nebulizer's performance would be objective, quantitative measurements of physical properties like:

• Aerosol Output Rate: The amount of medication delivered per unit of time.
• Particle Size Distribution: The range and average size of the aerosolized particles (specifically, the respirable fraction).

These are empirical measurements, not expert consensus, pathology, or outcomes data in the usual sense. The document states "Testing performed on the aerosol output and particle size," implying these direct measurements were the basis for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth needed for it.

Summary of Limitations from the Provided Text:

The provided 510(k) summary is very high-level and characteristic of device submissions from 1999 for physical medical products. It focuses heavily on establishing substantial equivalence to predicate devices based on functional characteristics, intended use, and general performance claims (high respirable output, similar aerosol treatment, long-term use). It lacks the detailed quantitative performance metrics, study designs, sample sizes, and ground truth methodologies that would be expected for more modern AI/software-as-a-medical-device (SaMD) submissions or even detailed clinical studies for novel physical devices. The FDA clearance is based on the premise that the new device is "substantially equivalent" to already marketed devices, implying that if the predicates were safe and effective, so too would be the new device given similar performance characteristics.

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The revised DeVilbiss 5 Liter Oxygen Concentrator is designed to provide supplemental low flow oxygen therapy for patients suffering from COPD, cardiovascular disease, and lung disorders. The oxygen concentrator is used in home type environments: homes, patient care facilities, etc.

The DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.

The revised DeVilbiss 5 Liter Oxygen Concentrator is a 1-5 lpm, pressure swing adsorption, oxygen concentrator based on molecular sieve technology. Room air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulates. A pneumatic valve directs air into one of the two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing an enriched oxygen product for the patient. Simultaneously in the other bed, nitrogen is desorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues, providing a continuous flow of oxygen at a purity of 93% +/-3% to the patient. The concentrator is available with or without an oxygen monitoring device.

The provided text describes a 510(k) submission for a medical device, the DeVilbiss 5 Liter Oxygen Concentrator. However, it does not contain information about a study with acceptance criteria in the typical sense of a clinical or performance study with a test set, ground truth established by experts, or sample sizes for training and testing.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. This pathway primarily relies on comparing the technological characteristics and performance of the new device to a device that is already legally on the market.

Here's an analysis based on your requested categories, highlighting where the information is available and where it's not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The "acceptance criteria" here are largely implicit, derived from industry standards and the comparison to the predicate device. The primary performance metric mentioned is oxygen purity.

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

• Sample Size for Test Set: Not applicable. This document does not describe a clinical or performance study with a test set of human/animal subjects or a dataset in the way an AI/ML study would. The performance data is stated as "Based on tests performed," implying internal engineering or bench testing, not a formal clinical trial with a defined test set.
• Data Provenance: Not applicable in the context of clinical data. The "tests performed" would likely be internal V&V (Verification and Validation) carried out by the manufacturer.

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

• Not applicable. Ground truth, in the sense of expert consensus on clinical cases, is not part of this 510(k) submission for an oxygen concentrator. The "ground truth" for this device's performance is objective measurement of oxygen purity.

4. Adjudication method for the test set

• Not applicable. There is no test set in the clinical/AI sense that would require 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

• Not applicable. This is not an AI-powered device, nor is it a diagnostic imaging device that would involve human readers.

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

• Not applicable. This is a standalone medical device (oxygen concentrator), but not in the context of an "algorithm only" performance study. Its performance (oxygen purity) is inherent to the device's function, not an algorithm's output.

7. The type of ground truth used

• Ground Truth: Objective measurements of oxygen purity (e.g., using an oxygen analyzer) and verification of other mechanical/electrical specifications (e.g., pressure relief valve function, alarm functionality). This is not an expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• 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

• Not applicable. No training set is involved.

Summary:

The provided document describes a 510(k) submission for an oxygen concentrator, which demonstrates substantial equivalence to "legally marketed predicate devices." The "study" referenced is not a typical clinical trial or AI performance study. Instead, it involves bench testing and engineering verification to confirm that the revised device meets established performance specifications (primarily oxygen purity) and that any changes (e.g., to the valve, cycling mechanism, or alarms) do not negatively impact safety and effectiveness compared to the predicate device. The "acceptance criteria" are therefore derived from the established performance of similar devices and general regulatory requirements for medical device safety and efficacy.

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The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use only on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).

The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on configuration) a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, suction tubing, internal battery, and an AC to DC adapter. The device is designed and manufactured to comply with UL 2601-1 and/or CAN/CSA-C22.2 No. 601.1 M90 safety standards.

The manufacturer, Sunrise Medical HHG Inc., states that the DeVilbiss Suction Unit will meet the performance standards per ISO 10079-1:1991, "Medical Suction Equipment", which covers aspects such as vacuum level, flow, construction, life test, and sound level. This standard itself outlines the acceptance criteria for these parameters.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the provided text states the device will meet the performance standards per ISO 10079-1:1991 without providing specific numeric values for the device's performance, the table will reflect the general nature of these criteria as described in the standard.

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

The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Performance Testing" was conducted to confirm compliance with ISO 10079-1:1991.

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

This information is not provided in the 510(k) summary. The performance testing described relates to engineering standards rather than clinical evaluation requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The testing relates to objective engineering measurements against a standard, not subjective clinical assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The 510(k) pertains to a non-diagnostic medical device (suction pump) and its performance against engineering standards, not a diagnostic algorithm or image analysis system. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

Yes, in a sense. The "Performance Testing" described is analogous to a standalone study for the device's physical and functional characteristics. The device (algorithm only, if considering its operational mechanics as an "algorithm") was tested independently against the engineering standard ISO 10079-1:1991. Human-in-the-loop performance is not a relevant concept for a suction pump's primary performance criteria.

7. The Type of Ground Truth Used:

The ground truth used for the performance testing of the DeVilbiss Suction Unit is the objective performance specifications and requirements outlined in the international standard ISO 10079-1:1991, "Medical Suction Equipment." This standard defines measurable targets for vacuum level, flow rate, construction integrity, operational life, and sound levels.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. Suction pumps are not typically developed using "training sets" in the context of machine learning or AI. Their design and manufacturing are based on engineering principles and iterative development/testing, not data-driven machine learning.

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

This information is not applicable. As stated above, a "training set" with established ground truth, as understood in AI/ML, is not relevant for the development and testing of a medical suction pump, which relies on established engineering and safety standards.

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The DeVilbiss Model 6305D Heavy Duty AC Aspirator is used primarily to provide a vacuum source for oral, nasal and pulmonary aspiration. The device is used on the order of a physician.

The DeVilbiss Model 6305D Heavy Duty AC Aspirator is an AC powered vacuum pump assembly designed to be used in conjunction with a collection canister to meet the requirements for oral, nasal and pulmonary aspiration.

Here's a breakdown of the acceptance criteria and the study details for the DeVilbiss Model 6305D Heavy Duty AC Aspirator, 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 provided text does not contain information about a "test set" in the context of a typical AI/software device evaluation. The evaluation is focused on the physical performance of the aspirator, not a diagnostic or AI-driven assessment of patient data. Therefore, the concepts of data provenance (country of origin, retrospective/prospective) are not applicable here.

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

This information is not applicable as the evaluation is not based on expert-established ground truths for a test set of data. The ground truth for performance is based on direct physical measurements of the device's vacuum pressure and flow rate.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it relevant to this type of device. This evaluation pertains to the physical performance of a medical device (an aspirator), not the diagnostic accuracy or human-in-the-loop performance with an AI system. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report.

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

A standalone performance study was implicitly done, but not in the context of an "algorithm." The device itself (the aspirator) was tested in a standalone manner to measure its physical performance (vacuum pressure and flow rate) against established criteria. This is an "algorithm only" in the most rudimentary sense of the device operating on its own.

7. Type of Ground Truth Used

The ground truth used for this evaluation was direct physical measurements of the device's performance characteristics (maximum deadhead vacuum pressure and minimum free flow rate). These are objective, quantifiable physical properties.

8. Sample Size for the Training Set

There is no concept of a "training set" for this device evaluation. The device is a physical product, not a machine learning model.

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

This question is not applicable as there is no training set for this device.

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