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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 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 Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.

The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts. Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure). The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure. The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals. The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Hamilton Medical VENTILAIR II Medical Air Compressor:

The provided text is a 510(k) summary for the Hamilton Medical VENTILAIR II Medical Air Compressor. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device). This typically involves comparing characteristics and performance data. The document does not describe acceptance criteria in the sense of predefined thresholds for a study to pass, but rather presents performance characteristics of the VENTILAIR II and compares them to predicate devices to establish substantial equivalence.

It's important to note that a 510(k) summary often summarizes testing, and a detailed study protocol with explicit acceptance criteria might be in the full submission, but not fully reproduced here.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices, and the "reported device performance" is that of the VENTILAIR II. The goal is to show the VENTILAIR II performs as well as or better than the predicates for the relevant characteristics.

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The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.

The Newport C250 Air Compressor is electric and produces air from the normal environment to supply compressed air for Newport ventilators.

This document appears to be a 510(k) summary for a medical device, the Newport C250 Air Compressor. It details the device's intended use, its substantial equivalence to predicate devices, and the testing performed. However, it does not contain a study that proves the device meets specific acceptance criteria in the format requested.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that comprehensive testing was conducted "in accordance with various industry recognized standards" and that "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table.

The standards mentioned are:

• IEC 60601-1-2:1993
• CSA 22.2 No 601-1-M90
• UL 2601-1
• EN 55011:1998 &A1:1999

These are general safety and electromagnetic compatibility (EMC) standards for medical electrical equipment. They would have specific test limits and pass/fail criteria, but these are not enumerated in the 510(k) summary. The summary only states that the device meets its specifications and is safe/effective, implying it passed the tests against these standards.

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

This type of information is not applicable to this 510(k) submission. The Newport C250 Air Compressor is an electromechanical device, not an AI/software device that processes data in the way typically associated with "test sets" or data provenance (e.g., country of origin for clinical images). Testing would involve a fixed number of physical units of the compressor, often a single unit or a small batch, subjected to rigorous environmental, electrical, and performance tests. The data provenance would be from laboratory testing.

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

This is not applicable to the Newport C250 Air Compressor. "Ground truth" established by experts is relevant for diagnostic or image analysis AI/software, not for a physical air compressor whose performance is measured by objective physical parameters (e.g., pressure, flow, purity, noise, electrical safety).

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in labeling or assessing data, which is not relevant for the testing of this physical 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:

Not applicable. This is a physical medical device (an air compressor), not an AI-assisted diagnostic or image analysis system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to its premarket submission.

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

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

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

Not applicable. The "ground truth" for a device like an air compressor would be its physical specifications and objective measurements of its performance (e.g., pressure output, air purity, noise levels, power consumption) against established engineering and safety standards.

8. The sample size for the training set:

Not applicable. Training sets are used for machine learning models, not for physical electromechanical devices like an air compressor.

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

Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding acceptance and testing:

• Acceptance Criteria (Implied): The device's specifications (e.g., "supply a source of clean, oil-free pressurized air at 42 psig") and compliance with the listed industry standards (IEC 60601-1-2, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011). While not numerically stated here, these standards contain specific, measurable acceptance criteria.
• Study/Testing Information: "Comprehensive testing has been conducted... in accordance with various industry recognized standards." The results of this testing "provides assurance that the device meets its specifications and is safe and effective for its intended use." The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate, often through a combination of design, performance testing, and comparison of technical characteristics to the predicate. The FDA's clearance implies they were satisfied with the demonstration of compliance with the standards and the device's specifications.

This 510(k) summary is typical for a Class II electromechanical device that does not involve AI or complex data analysis, hence the absence of the detailed information about test sets, experts, or training data that you requested.

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The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are ACpowered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.

These line powered piston compressors are housed in a plastic cabinet (case). The plastic cabinet is the only distinctive component between the three devices, that are identical for all other components, material and characteristics. Dimensions are 4.7 in. x 9.1 x 7.5 in. and weight 3.3 lbs. P3, P4 and P5 units contain no microprocessors or other electronic components. They operate from 115 VAC, 60 Hz. Each unit is supplied with an instruction manual and an accessory kit containing a nebulizer pediatric mask, a mouthpiece.

The provided document describes a 510(k) premarket notification for MED2000 SpA Nebulizer Compressors, Models P3, P4, and P5. This submission focuses on establishing substantial equivalence to a predicate device (Med2000 SpA Nebulizer Compressor, Models P1 and P2). The testing performed is primarily non-clinical, demonstrating safety and effectiveness in accordance with FDA guidance, rather than a study proving specific acceptance criteria related to disease diagnosis or treatment efficacy.

Therefore, many of the requested elements are not applicable to this type of regulatory submission. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Specific Tests Performed (acting as implicit acceptance criteria for safety and performance):

• EPA PM 2.5 Testing
• EMC testing
• Dielectric Withstand
• Current Dispersion Test or Leakage Current Test
• Surface Temperature Test
• Air Temperature Test
• Storage conditions Operating environment extremes
• Sinusoidal Vibration Test
• Impact Resistance - Drop Test
• Fluid Spill Resistance Test

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set for clinical performance, as it primarily relies on non-clinical engineering and performance testing. The "device sample(s) tested" is mentioned, but the exact number isn't quantified. The data provenance is internal testing performed by the manufacturer, MED2000 SpA, or its contracted labs, for regulatory submission purposes, and is inherently "prospective" for the purpose of demonstrating equivalence. The country of origin of the manufacturer is Italy.

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 nebulizer compressor, and its performance is evaluated through engineering and safety tests rather than clinical outcomes requiring expert-established ground truth.

4. Adjudication method for the test set
Not applicable. The tests performed are objective engineering and safety measurements, not subjective evaluations requiring 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 a medical device (nebulizer compressor), not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" in the context of its function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of submission is defined by established engineering standards, regulatory guidance (e.g., FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND), and comparison to the predicate device's known performance for safety and basic operational characteristics. There is no clinical "ground truth" like pathology or outcomes data needed for this 510(k) submission.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.

The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1.

The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.

The provided text describes a Medical Air Compressor and its regulatory clearance, not an AI/ML device. Therefore, many of the requested criteria related to AI/ML device evaluation (such as expert adjudication, MRMC studies, standalone performance, and training/test set details) are not applicable to this document.

Here's a breakdown of the applicable information:

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

The document does not explicitly present a quantitative "acceptance criteria" table in the way one might expect for an AI/ML device that generates specific performance metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with voluntary and international standards.

• Materials and Design: "The materials and design of this device are similar to those of the predicate device (Drager Inc. Medical Air Compressor, Model 98, K982789)."
• Technical Characteristics: "The technical characteristics of the Independence™ Medical Air Compressor do not introduce new questions regarding safety or effectiveness."
• Labeling: "the labeling associated with the Independence™ Medical Air Compressor provides similar information as the predicate device." |
  | 2. Safety and Effectiveness | - Performance Testing: "Performance testing was conducted per internal, company requirements."
• Environmental and EMC Testing: "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
• Compliance with Standards: "The Independence™ Compressor device is also compliant with various voluntary and international standards including: IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."
• Overall Conclusion: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." and "In summary eVent Medical Ltd. has demonstrated the Independence™ Medical Air Compressor to be safe and effective." |
  | 3. Regulatory Classification | - Classification: Class II per 21 CFR 868.6250, Portable Air Compressor. (Matches predicate and regulatory requirements). |

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. For a medical air compressor, "test set" would likely refer to engineering validation and verification tests, not a clinical data set.

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 is not applicable as the device is a medical air compressor, not an AI/ML diagnostic tool requiring expert ground truth in a clinical context.

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

This is not applicable for the reasons stated above.

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 is not applicable. The device is an air compressor, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical product, not an algorithm.

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

For a medical air compressor, "ground truth" would be related to engineering specifications and performance metrics. The document states:

• "Performance testing was conducted per internal, company requirements."
• "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
• Compliance with "IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."

Therefore, the "ground truth" or reference standards are the engineering specifications, regulatory guidance documents, and international voluntary standards.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML product that learns from training data.

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

This is not applicable as the device is not an AI/ML product.

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