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The Breathe Technologies Life2000™ Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

The Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor.

The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System is applicable for adult patients who require the following types of ventilatory support:

• · Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• · Assist/Control mode of ventilation.

The System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

The Breathe Technologies Life2000 Ventilation System includes a portable, battery powered, continuous ventilator that was cleared in K141943 along with the Breathe Pillows Interface, Universal Connector and various other dedicated accessories.

In this submission, the Life2000 Ventilation System is expanding with the inclusion of additional components, including the Life2000 Compressor, a portable air compressor. This Life2000 Compressor provides a primary source of compressed air for the Life2000 Ventilator, in addition to the previously cleared gas sources of facility in-wall compressed gas (air & oxygen) and tanks of compressed medical gas. The Life2000 Compressor provides a dedicated docking station for the Life2000 Ventilator.

The Ventilator administers the physician-prescribed volume to the patient via the previously cleared Breathe Technologies Universal Connector which connects into the patient's tracheostomy tube, endotracheal tube, or any off the shelf non-invasive mask. It can also be used with the previously cleared Breathe Technologies Pillows Interface (K141943), a type of nasal mask.

This submission includes new versions of the Pillows Interface, labeled as the Breathe Pillows Entrainment Interface, that have an inlet for supplemental oxygen. It also includes labeling for the use of third party supplemental Oxygen Adapters for use with the Universal Connector. These inlets or Adapters allow the physician to administer supplemental oxygen into the patient circuit or interface.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes a Breathe Technologies Life2000™ Ventilation System seeking 510(k) clearance, intending to demonstrate substantial equivalence to its predicate device (the previous version of the Life2000 Ventilation System, K141943) and a reference device (Siemens Compressor Mini, K023354). The acceptance criteria are largely implied by compliance with various medical device standards and through bench testing and human factors validation. The "device performance" is primarily assessed against the predicate and reference devices, demonstrating functional equivalence and safety.

Since specific quantitative acceptance criteria with numerical targets and direct performance comparisons are not explicitly laid out in a table in the provided text, I will infer them from the comparisons made to the predicate and reference devices, and the standards listed.

Inferred Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance

• Test Set (Human Factors Validation - HFV): "over 100 participants"

  • Data Provenance: Not explicitly stated, but the context of an FDA submission for a US company (Breathe Technologies, Irvine, CA) suggests the data is likely from the USA and would be prospective as it involves active testing with participants for validation.
  • Test Set (Bench Testing): Not explicitly stated, but typically involves a number of units sufficient to demonstrate design validation and compliance with standards.

• Training Set: Not mentioned in the provided text. The document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device through testing and comparison, rather than developing a new algorithm/AI from a training set.

3. Number of Experts and their Qualifications (for Ground Truth)

• Human Factors Validation: No explicit mention of experts establishing a "ground truth" for the test set in the traditional sense (e.g., radiologists interpreting images). The HFV tests evaluated user performance against usability objectives (safe and effective use).
  • The study involved diverse user groups: Patients, Caregivers, Respiratory Therapists, and Physicians and Critical Care Nurses. Their performance in using the device constituted the primary evaluation in the HFV. Their "qualifications" are implied by their roles as end-users of the device.

4. Adjudication Method (for Test Set)

• The document does not describe an adjudication method in the context of expert consensus, as it is not an interpretative study. The Human Factors Validation (HFV) tests assessed user performance directly.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a substantial equivalence submission for a physical medical device (ventilator system), not an AI/software device requiring human reader interpretation or assistance. Therefore, there is no discussion of AI assistance or its effect size on human readers.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This is a hardware medical device (ventilator system and accessories), not an algorithm or AI. Standalone performance for this device would refer to its functional performance as a ventilator (volume, pressure, alarms, etc.), which was tested through bench testing and compliance with various standards, as listed. The "algorithm" in this context would be the device's control software, which is implicitly validated through the functional and performance testing.

7. Type of Ground Truth Used

• For Human Factors Validation: The ground truth was implicitly the observed safe and effective use of the device by representative users (patients, caregivers, respiratory therapists, physicians, and critical care nurses) in simulated environments, as evaluated against predefined usability goals and error detection.
• For Bench Testing and Compliance: The ground truth was established by approved engineering specifications, international/national standards, and regulatory guidelines (e.g., ISO 10993-1, FDA Draft Reviewer Guide for Ventilators, ASTM F1246-91, AAMI/ANSI 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-72, IEC 62133, IEC 62366, FDA Guidance Documents). The device's performance was measured against these objective criteria.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. The document does not describe a machine learning algorithm or AI component that would require a distinct training set. The submission focuses on validating hardware components and their integrated system.

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

• Not applicable. As no training set for an AI/algorithm is mentioned, the method for establishing its ground truth is not discussed.

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The Ombra® Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.

The Ombra* Table Top Compressor provides a source of compressed air for use with jet nebulizers. The device is a motor-driven compressor, housed in a plastic case with rubber skids. It operates from 120V/60Hz. It is supplied with several replaceable air filters. The Ombra* Table Top Compressor is intended for adult, child and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

The Ombra* Table Top Compressor is a medical device designed to provide compressed air for use with jet nebulizers. The provided text details the device's characteristics and its comparison to predicate devices, but it does not describe a study involving acceptance criteria in the traditional sense of clinical performance or algorithm evaluation.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This is a common pathway for medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria based on patient outcomes are often not required if the new device is sufficiently similar to a predicate.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in this context.

Here's the information that can be extracted from the provided text, framed within the substantial equivalence approach:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are typically defined by demonstrating that the new device's parameters are comparable to or within acceptable limits relative to the predicate devices, and that it complies with relevant safety and performance standards.

The "study" that proves the device meets these criteria is the "Non-Clinical Test Summary."

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

• Sample size: Not specified as a "sample size" in the context of patient data. The testing involved one unit of the Ombra* Table Top Compressor to characterize its operating parameters.
• Data provenance: Not applicable in the context of clinical data. The tests were conducted internally to characterize the device's physical and electrical properties.

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 this context refers to objective measurements of the device's physical and electrical performance, not expert clinical interpretation.

4. Adjudication method for the test set:

• Not applicable. There was no human interpretation or adjudication involved in the objective measurements.

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 device is a compressor, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a standalone hardware component. Its performance is measured directly, not via an algorithm.

7. The type of ground truth used:

• Objective physical and electrical measurements of the device's operating parameters (e.g., pressure, flow rate, current, sound level, temperature ranges) and compliance with recognized safety and EMC standards. Comparisons were made against the specifications of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. As there is no training set, this question is irrelevant.

In summary, the Ombra Table Top Compressor gained clearance through a 510(k) submission based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing and adherence to recognized electrical and electromagnetic compatibility standards.* The "acceptance criteria" were met by showing that its technical specifications were comparable to predicates and that it complied with relevant safety standards, raising no new safety or effectiveness concerns. No clinical performance studies or AI-related evaluations were conducted or required for this type of device.

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The Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.

The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical

The Oricare C4500 Medical Air Compressor is a medical device designed to supply dry, filtered, and compressed air to medical ventilators. The submission provides a "Substantial Equivalence Summary" rather than a detailed study report with acceptance criteria and direct performance metrics. However, it implicitly demonstrates that the device meets acceptance criteria by establishing substantial equivalence to a legally marketed predicate device, the EKOM DK50 D Medical Compressor (K060781). This is achieved by comparing various operational and physical characteristics of the Oricare C4500 against those of the predicate device.

Here's an analysis based on the provided text, outlining the acceptance criteria (inferred from predicate device characteristics) and the reported performance of the Oricare C4500:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are inferred from the specifications of the predicate device, the EKOM DK50 D Medical Compressor (K060781). The reported device performance is that of the Oricare C4500 Air Compressor, demonstrating that it either matches or has minor, non-adverse differences compared to the predicate.

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Indicated for supplying compressed air for medical ventilators.

The Ekom model DK50 DS is a portable air compressor designed to supply air to medical equipment, i.e., ventilators.

The Model DK50 DS contain an oil-free piston compressor driven by a low maintenance single phase electric motor. Compressed air is cooled where condensed water is separated into a vessel. Incoming air passes through 2 filters and undergoes double filtration as it passes through the system. Constant output pressure is maintained by a pressure regulator. There is a built-in air tank which allows peak air consumption of 200 Lpm.

The device may be used as a standby source of air. In this configuration, the respiratory equipment is supplied with compressed air from the facilities central air distribution. Air pressure in this central distribution is sensed by the Ekom pressure sensor. If the pressure is sufficient, the compressor stays in the STANDBY mode. If the pressure falls the compressor automatically starts and becomes the main air supply.

When the compressor is used as the main source, the control unit determines its operation according to the current need for air. If air consumption is zero, the device switches to STANDBY.

The compressor is equipped with indicators for output pressure, operation hours, power status, drying efficiency and battery condition as well as acoustic and optic alarms to warn of high operating temperature, low output pressure and loss power.

The provided document describes a medical device (portable air compressor DK50 DS) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML or diagnostic device.

The document focuses on:

• Device Description: A portable air compressor designed to supply air to medical ventilators.

• Indications for Use: Supplying compressed air for medical ventilators in hospital or sub-acute institution environments.

• Substantial Equivalence: A comparison of the DK50 DS with two predicate devices (K060781 - Ekom Model DK50 D and K041406 - Newport Model C250) based on specifications like output flow, power, alarms, and physical dimensions.

This is a 510(k) premarket notification for a traditional medical device (a portable air compressor), not an AI/ML-driven diagnostic or image analysis tool. Therefore, the concepts of acceptance criteria for diagnostic performance (like sensitivity, specificity), ground truth, test/training sets, expert adjudication, or MRMC studies are not applicable to the information provided.

The "acceptance criteria" discussed in the document are effectively the technical specifications and performance characteristics compared against the predicate devices to establish substantial equivalence.

Therefore, I cannot provide the requested information because it is not present in the given text.

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The device is a portable air compressor intended to provide compressed air for medical purposes. It is used with a pneumatic nebulizer to administer humidified air or medication to the patient. The device is intended for use on adult and pediatric patients in a home health care or institutional environment. It's not approved for use with ventilators.

The EMG TRITON-COMP. Is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital use. It is capable of servicing nebulizers and humidifiers to produce particle aerosol mist. The EMG TRITON-COMP. Powered by AC current (115V 60Hz) through the wall electric outlet at home, Maximum constant working pressure at 50psi, delivering up to 22LPM of flow (at pressure 10psi) and does not need software to drive. The outlet compressed air pressure of EMG TRITON-COMP. is produced through a built-in compressor. The consist parts include motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve ----etc. When turns on the compressor, motor starts to run and its shaft drives the eccentric crank to actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down strike, a vacuum pressure is produced in the cvlinder, then the air will be sucked into the cylinder through an one-way inlet port. When the piston is being in the up strike, it presses out the air through the other outlet port to the atmosphere, these two one-way ports avoid the air being sucked from the atmosphere as well as the air in cylinder being pressed back to the inlet port. When motor keeps running, then the compressed air through outlet port is produced. One set of iron cover with protective earth encloses the compressor and wire harness to protect user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a compressed air pressure regulator, pressure gauge and air outlet port. The pressure regulator connected to the air outlet tube of compressor. The pressure gauge and the compressed air outlet port are connected to the pressure regulator through a three way connector and inner tube. Device's compressed air pressure can be adjusted by tuning the knob of pressure regulator, accuracy within +/-5%. The pressure gauge display the pressure data during operation.

The provided document describes a 510(k) premarket notification for a medical device, the EMG TRITON-COMP. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with AI components. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

Here's the information that can be extracted or inferred:

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

The document doesn't explicitly state acceptance criteria in a quantitative table format with corresponding performance results in the way one would see for a novel device undergoing clinical trials. Instead, it relies on demonstrating compliance with safety standards and similarity to predicate devices. The "performance validation test" mentioned includes:

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness. The reported performance is that it is the same as the predicate device for the listed validation tests, and it also meets specified safety standards.

2. Sample sized 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 refers to "performance validation tests" but does not detail the methodology, sample sizes, or data provenance for these tests. This is typical for a 510(k) summary relying on engineering and bench testing rather than clinical study 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/not provided. The device is an air compressor, and its performance tests would involve measurements of physical parameters (pressure, flow rate, etc.) for which "ground truth" is established by calibrated instruments and engineering specifications, not expert human assessment in a clinical context.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments, typically in clinical studies or human-in-the-loop performance evaluations, which are not described for this device.

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

An MRMC study was not done. This device is a portable air compressor, not an AI diagnostic tool. Therefore, human reader improvement with or without AI assistance is not applicable.

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

This information is not applicable. The device is a physical air compressor, not an algorithm.

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

The "ground truth" for the device's technical specifications and performance tests would be based on engineering specifications, calibrated measurement systems, and established test protocols for mechanical and electrical devices. For example, pressure gauge accuracy is verified against a master calibrated gauge, and flow rates are measured using calibrated flowmeters. No expert consensus, pathology, or outcomes data are mentioned as ground truth.

8. The sample size for the training set

This information is not applicable/not provided. This device is a mechanical compressor, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

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

This information is not applicable/not provided as there is no training set mentioned for this device.

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The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03 are intended to provide a source of compressed air for medical purposes, to be used in home health care and hospital use. The Walkie-Neb model is intended to be used only in home health care.

These devices are indicated for use with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.

The nebulizer compressors Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb. FJ03, Q03 and Walkie-Neb are a family of nebulizer compressors intended to be used as compressed air generators for pneumatic nebulizers used by patients for aerosol therapy. There are 7 model families with an AC powered motor (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, and Q03) and one model with a DC low voltage motor (Walkie-Neb), with a rechargeable battery pack and an external charger/power supplier.

The 7 AC model families have different plastic housings, which define the model name of the product. Inside they have the same compressor but with different electrical motors, to provide different pneumatic performances.

Here's an analysis of the provided 510(k) summary regarding the nebulizer compressors, focusing on acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

For this device, the acceptance criteria are not explicitly stated as numerical thresholds (e.g., "sensitivity must be >90%"). Instead, the core acceptance criterion for these nebulizer compressors is substantial equivalence to their predicate devices based on equivalent operating flow rate and pressure. The study demonstrates this equivalence through performance tests.

• Flaem Nuova compressors (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03 and Walkie-Neb): Have the same performance, safety, and EMC requirements as the predicate devices.
• AC Flaem Nuova compressors (series F700): Have the identical operating pressure and flow ranges as the Respironics Mister Neb compressor (K013027).
• AC Flaem Nuova compressors (series F1000 and F1500): Have the identical operating pressure and flow ranges as the Healthdyne Inc. NEBULIZER SYSTEM compressor (K922623).
• Walkie Neb Model: Has equivalent operating pressure and flow ranges to the Respironics Mister Neb compressor (K013027). |
  | Intended Use: The new devices must have the same or equivalent intended use as the predicate devices. | Achieved Equivalence:
• The Flaem Nuova compressors and the predicate devices (explicitly mentioning Salter Labs, Salter Aire Compressor, K992285) are indicated for the same intended use.
• The new devices are intended to provide a source of compressed air for medical purposes, for use with pneumatic nebulizers to produce aerosol mist for respiratory therapy in adult and pediatric patients. This aligns with typical nebulizer compressor intended uses. |
  | Technology/Design: The new devices' technological characteristics should be substantially equivalent to the predicate devices. | Achieved Equivalence:
• AC and DC power supply: Same as predicate devices.
• Internal Compressor (for AC models F700, F1000, F1500) and electrical motors: Identical or very similar to specific predicate devices, leading to identical performance.
• Walkie Neb: Mechanical configuration, batteries, charging system, and accessories are substantially equivalent to Invacare Portable Desktop (K042483). |

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

The document does not specify a "test set" in the context of clinical trials involving human subjects or a defined set of performance measurements on a specific number of units in a population study. The performance tests are described as in-house laboratory engineering tests performed by Flaem Nuova on their own devices.

• Sample Size: Not specified quantitatively. It likely refers to testing individual units of each model family (Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, FJ03, Q03, and Walkie-Neb) rather than a statistically significant sample size of manufactured devices.
• Data Provenance: The tests were conducted by Flaem Nuova, the manufacturer, in Italy. The data is thus retrospective in the sense that it's based on tests already completed on their devices. It is not clinical data from patients.

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

This information is not applicable to this type of device and study. The "ground truth" here is the measured physical performance (flow rate and pressure) of the devices, compared against the known specifications or performance of the predicate devices. This does not involve expert interpretation or subjective assessment of clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no expert interpretation or human assessment of results where discrepancies might occur, no adjudication method (like 2+1, 3+1) is needed. The performance is measured objectively.

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

No, an MRMC comparative effectiveness study was not performed. This type of study would involve human readers (e.g., clinicians) assessing cases both with and without AI assistance, which is not relevant for a nebulizer compressor. The submission explicitly states: "Clinical data were not required."

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 (nebulizer compressor), not an AI algorithm. Its performance is inherent to its mechanical and electrical design, not dependent on an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering performance specifications and comparative measurements. Specifically:

• The "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993, which outlines the expected performance parameters for such devices.
• The known operating flow rate and pressure of the identified predicate devices. The new devices' measurements were compared directly against these established values to demonstrate equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of machine learning for this physical device. The device's design and manufacturing are based on engineering principles, not an iterative learning process from a dataset.

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

This information is not applicable as there is no training set for a physical nebulizer compressor.

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The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.

The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators.

The provided text describes a 510(k) premarket notification for two medical compressors, DK50 D and DK50 DM. It details their intended use, describes them as substantially equivalent to a predicate device, and lists the standards they were tested against. However, the document does NOT contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/ML device.

This document is for a traditional medical device (compressors), not an AI/ML device, and therefore the concepts of "acceptance criteria" and "device performance" are addressed differently. The "study" mentioned is a general statement about adherence to industry standards, not a specific clinical or performance evaluation with statistical metrics.

Given the information provided, here's how the questions can be addressed:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria: Not explicitly stated as quantifiable metrics in the document. The general acceptance criterion is that the device "meets its specifications and is safe and effective for its intended use" and is "substantially equivalent" to the predicate device.
   • Reported Device Performance: The document states that "Comprehensive testing has been conducted on The DK50 D and DK50 DM Medical Compressors in accordance with various industry recognized standards, including: IEC 60601-1-2:2001, EN 55011:1998 &A1:1999." The outcome of this testing is that the device "meets its specifications." Specific performance metrics (e.g., flow rate, pressure, noise levels, durability) are not detailed in this summary.

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

   • Not applicable / Not provided. The testing mentioned refers to engineering and quality assurance testing against standards, not a clinical study with a "test set" of patients or data in the context of AI/ML.

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)

   • Not applicable / Not provided. Ground truth is not established in this context. The "truth" is whether the device adheres to engineering specifications and safety standards.

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

   • Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are relevant for interpreting complex data, often in clinical imaging or diagnostic studies, where human consensus is needed for ground truth. This is not
     pertinent to the testing of an air compressor.

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 / Not done. MRMC studies are for evaluating human performance, often with or without AI assistance, usually in diagnostic tasks. This device is an air compressor, not a diagnostic tool, and has no human-in-the-loop AI component.

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

   • Not applicable / Not done. This refers to AI algorithm performance. The device is a mechanical compressor.

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

   • Not applicable / Not provided. In the context of this device, "ground truth" would be the engineering specifications and performance parameters as defined by internal design documents and relevant industry standards. The summary does not provide specific details on how conformity to these was verified beyond stating "comprehensive testing."

8. The sample size for the training set

   • Not applicable / Not provided. This concept is for AI/ML models.

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

   • Not applicable / Not provided. This concept is for AI/ML models.

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The Precision Medical, Inc. Minimate compressor is intended to provide compressed air to a hand held medication small volume nebulizer. The device is not intended as a life supporting device.

The compressor is made up of three basic sections - l. Electrical motor - 2. Compressor - 3. Housing. A 1/30 hp electrical motor drives the air compressor. The compressor is a piston type, which is self lubricating, thus providing a oil free, air supply to the nebulizer. The housing provides protection for the components, reduces noise, and dampens the vibration from the compressor. The housing also protects the end user from the components of the device.

This 510(k) summary for the Precision Medical PM5 MiniMate Compressor primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a study designed to rigorously prove device performance against specific metrics. The provided text is a regulatory submission, not a scientific study report.

Therefore, many of the requested sections cannot be filled based on the provided document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document implies the acceptance criterion is that the device passes specific tests. However, the quantitative thresholds for these tests are not provided.

Reported Device Performance:
"The Precision Medical, Inc. Minimate compressor PM5 successfully passed tests in the following areas; Mechanical / Climatic Electrical Device Performance"
No specific quantitative performance metrics are provided.

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

Not provided in the document. This is a regulatory summary, not a detailed test report.

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

Not applicable. This device is a compressor, not a diagnostic imaging or AI device that would require expert-established ground truth for performance evaluation in the way described. Its performance is measured against engineering specifications.

4. Adjudication Method for the Test Set

Not applicable for this type of device and submission.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved.

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

Not applicable. This device is a mechanical compressor, not an algorithm.

7. The Type of Ground Truth Used

For a device like a compressor, "ground truth" would be established by engineering standards and specifications, validated through laboratory testing using calibrated equipment. The document states it "successfully passed tests" in Mechanical, Climatic, Electrical, and Device Performance areas, implying these engineering standards were met.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing processes are subject to quality system regulations, but there's no "training" in the AI sense.

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

Not applicable. See point 8.

Summary of available information:

The provided document is a 510(k) summary for a medical device (a portable nebulizer compressor). Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a detailed scientific study with AI-specific performance metrics. The "study" referenced is general performance testing (mechanical, climatic, electrical, device performance) that the device successfully passed, but no specifics on methodologies, sample sizes, or quantitative results are included in this summary.

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The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include:

• Volume Controlled (VCV) .
• Pressure Controlled (PCV) .
• Pressure Controlled, Volume Guaranteed (PCV-VG) ●
• Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) ●
• Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC) .
• Bi-level Airway Pressure Ventilation ●
• Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
• Apnea backup (active in Bi-level and CPAP/PSV) .

The Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation is a complete system featuring patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.

The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling and an integrated air compressor.

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Note: The document provided is a 510(k) summary for a medical device (ventilator). These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner one might find for a novel diagnostic algorithm. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not typically found or disclosed in this type of regulatory filing for this class of device. The "studies" for this device often refer to engineering tests and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. For this type of device, "testing" primarily refers to engineering verification and validation against performance specifications and recognized standards, not necessarily a "test set" of patient data in the way one would analyze an AI algorithm.
• Data Provenance: Not applicable in the context of clinical patient data. The "study" refers to engineering and quality assurance testing.

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

• Not specified or applicable. The ground truth for a ventilator's performance is typically established by metrological standards, engineering specifications, and functional testing, not by expert clinician consensus on a dataset.

4. Adjudication method for the test set

• Not specified or applicable. Adjudication methods are typically used for subjective clinical interpretations, which is not the primary assessment method for a ventilator's functional performance in this context.

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 done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists, pathologists). The GE Datex-Ohmeda Engstrom Carestation is a standalone mechanical ventilator; it does not involve human "readers" interpreting output with or without AI assistance in this manner.

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

• Yes, in essence. The "performance" of the ventilator is "standalone" in that its operation (controlling gases, delivering breaths, monitoring) is independent of human interpretation in the way an AI algorithm might be. The device's integrated measurement capabilities (FiO2, airway pressure, spirometry, volume monitoring) perform their functions autonomously. However, this is not a standalone "algorithm" in the context of an AI-driven diagnostic. It is the core function of the device itself.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by:
  • Engineering specifications and design requirements: Ensuring the device can deliver specified volumes, pressures, and modes of ventilation accurately.
  • Compliance with recognized voluntary standards: (e.g., UL 2601, ASTM F1100, EN/IEC 60601 series). These standards define acceptable performance characteristics and safety criteria.
  • Functional tests and calibration: Verifying that components and the overall system operate within specified tolerances.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm trained on a dataset. Its design and validation rely on engineering principles, component testing, and system-level functional verification.

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

• Not applicable, as there is no "training set" in the context of an AI algorithm.

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The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include:

• Volume Controlled (VCV) .
• Pressure Controlled (PCV) ●
• Pressure Controlled, Volume Guaranteed (PCV-VG)
• Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) .
• Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC) ◆
• Bi-level Airway Pressure Ventilation .
• Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
• Apnea backup (active in Bi-level and CPAP/PSV) .

The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

The Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation is a complete system featuring patient monitoring, patient vertilation, and the capability of interfacing with central information management systems.

The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling and an integrated air compressor.

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows nower, nebulization, and pneumatic gas flow to and from the vehinder ann some bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Additional optional accessories include a trolley/cart, compressor, airway modules, module bay, Additional optional water trap mounting brackets, and auxiliary electrical outlets. Support ann, mamamor and watcher is provided via the ventilator display unit. The rne ason internate for Nebulizer (K021175) is provided standard with the unit.

The provided text describes a 510(k) submission for the "GE Datex-Ohmeda Engstrom Carestation," a continuous ventilator. This document explicitly states that the device has been validated through "rigorous testing that, in part, supports the compliance" of the device to several voluntary standards.

However, the provided text does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy related to disease detection or diagnosis.

Instead, this document is a regulatory submission demonstrating substantial equivalence to a predicate device and compliance with applicable safety and performance standards for a medical ventilator. The "acceptance criteria" here are compliance with these regulatory and voluntary standards, and the "study" is the rigorous testing mentioned, but the specifics are not detailed in the provided text.

Therefore, I cannot fill out the detailed table and answer the specific questions about sample size, expert ground truth, MRMC studies, or standalone performance as they relate to performance metrics typically expected for AI/diagnostic devices. The information provided is for a traditional medical device (ventilator).

Here's what I can extract from the provided text based on the general nature of the request:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions that relate to AI/Diagnostic studies, the document does not provide the necessary information:

2. Sample sized used for the test set and the data provenance: Not applicable/Provided. This document is for a physical medical device (ventilator), not a diagnostic algorithm. The "testing" refers to verification and validation against engineering specifications and regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth, in the context of this device, relates to its ability to meet performance specifications (e.g., deliver set volumes/pressures, maintain alarms accurately), which would be assessed by engineers and testing personnel against pre-defined engineering requirements and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided. This is not a study requiring adjudication of diagnostic outputs.

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 device is a ventilator, not an AI or diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a ventilator, not an algorithm being assessed in standalone mode.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for a ventilator's performance would be its adherence to established engineering specifications and physiological parameters (e.g., accuracy of delivered tidal volume, pressure control, alarm functionality) as measured by calibrated equipment and verified against relevant standards (e.g., ISO, ASTM, IEC). The specifics are not detailed here.

8. The sample size for the training set: Not applicable/Provided. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable/Provided.

In summary: The provided document is a 510(k) summary for a ventilator, focusing on its substantial equivalence to predicate devices and compliance with safety and performance standards. It does not contain the detailed study information typically found for AI or diagnostic devices, which is what the individual questions are tailored for. The "acceptance criteria" are the regulatory and voluntary standards, and the "study" is the internal "rigorous testing" conducted by the manufacturer to demonstrate compliance, the specifics of which are not disclosed in this summary document.

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