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The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.

The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit. Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required. The device consists of four basic elements: Base Device, Extendible Cable, Oxygen Sensor W/ Diverter Fitting, and Tee Adaptor.

Here's a breakdown of the acceptance criteria and study information for the Precision Medical Inc. PM5950 Accu O2 Oxygen Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for tests related to accuracy, drift, response time, etc. It lists a series of compliance reports and tests performed by Precision Medical Inc. to demonstrate substantial equivalence. These are:

• Ingress of water ISO 80601-2-55 (201.11.6.5)
• Oxygen Analyzer Measurement Accuracy ISO 80601-2-55:2011 (201.12.1.101,102,104)
• Shock & Vibration Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (201.15.3.5.101)
• EMC Testing for PM5950 Oxygen Analyzer ISO 80601-2-55:2011 (202.6.2)
• Oxygen Analyzer - Leakage to Atmosphere ISO 80601-2-55:2011 (201.102)
• Operating and Storage Temp
• Operating and Storage Temperature of the PM5950 O2 Analyzer Review
• Software Validation of PM5950
• Effects of Elevation-Barometric Pressure Change
• Drop Test of PM5950 in Shipping Box
• Performance Test
• Process Validation of the PM5950
• Life Expectancy of the Keypad
• Label Durability
• Cleaning and disinfection of ME Equipment of ME Systems
• Compatibility with substances used with ME Equipment

The data provenance is from in-house testing conducted by Precision Medical, Inc. in the USA. The data is prospective in nature, as it was generated specifically for the 510(k) submission to demonstrate compliance.

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

This information is not provided in the document. The testing appears to be primarily engineering and performance verification against specified technical standards and internal criteria, rather than expert-based ground truth establishment for a diagnostic output.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (an oxygen analyzer), testing would likely involve direct measurement against known gas concentrations or calibrated reference instruments, rather than human adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI devices where human readers are involved in making diagnoses or assessments. The PM5950 Accu O2 Analyzer is a measurement device for oxygen concentration.

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

Yes, a standalone performance evaluation was done. The entire suite of tests (accuracy, response time, drift, environmental robustness, software validation, etc.) outlined in section "8. Declarations of Conformity and Summary Reports" represents the standalone performance evaluation of the device itself. The device is designed to provide direct measurements without human interpretation or algorithm modification once calibrated.

7. The Type of Ground Truth Used

The ground truth for the device's performance (e.g., accuracy, response time) would be established using calibrated reference standards and instruments to generate known oxygen concentrations. For other tests (like shock, vibration, ingress of water, EMC), the ground truth is defined by the specific requirements and methodologies of the referenced international and national consensus standards (e.g., ISO 80601-2-55, IEC 60601 series).

8. The Sample Size for the Training Set

This information is not applicable/not provided. The PM5950 Accu O2 Analyzer is a hardware-based measurement device that relies on a galvanic fuel cell sensor and a microprocessor. It does not appear to utilize machine learning or AI models that require a "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification.

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

This information is not applicable/not provided for the reasons stated above (no AI/ML training set).

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The Easy Go Aspirator provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / health care environments.

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses an internal battery, with internal charger/power supply, on two models, and AC only on the third model.

I am sorry, but based on the provided text, there is no information regarding acceptance criteria related to device performance, nor any study conducted to prove the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence of a new medical aspirator (PM66) to a predicate device (PM65) by highlighting:

• Device Descriptions: Comparing the general features and specific models of the new device (PM66LI, PM66AC, PM66S) to the predicate (PM65).
• Differences: Listing the new features and enhancements in the PM66 models, such as internal battery chargers, Lithium batteries, AC-only operation, charge/battery level indicators, and waste container options.
• Conclusion of Equivalence: Stating that the new devices are substantially equivalent to the predicate, with added features that ease and enhance operation, implying that their safety and effectiveness are comparable.
• Intended Use: Defining the purpose and environment for the device.
• Applied Standards: Listing various ISO and IEC standards that the device adheres to.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a study with sample sizes, data provenance, or ground truth establishment.
• Information on expert involvement or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm performance study.
• Information on training set sample sizes or ground truth establishment for a training set.

This type of 510(k) submission generally relies on demonstrating that the new device has "substantially equivalent" technological characteristics and/or intended use to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific statistical outcomes to meet "acceptance criteria" in the way one might see for a novel AI/software device. The equivalence often relies on engineering comparisons, bench testing (to ensure it meets listed standards like vacuum pressure), and sometimes non-clinical performance data to show the new features don't negatively impact safety or effectiveness.

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The Precision Medical EasyPulse portable oxygen concentrator (model PM4150) is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device can be used in a home, institution, vehicle and for transportable use.

The EasyPulse Portable Oxygen Concentrator (POC), model PM4150, was designed to provide supplemental oxygen to patients requiring oxygen therapy. The EasyPulse POC uses electronic conserving device technology to provide the patient with a lightweight, battery powered oxygen concentrator. The device can be used in the home, institution, vehicle and various mobile environments. A nasal cannula is used to channel oxygen from the device to the patient. The device is not intended to be life supporting or life sustaining.

The EasyPulse POC provides pulsed dose delivery to the user through a selection of 5 settings. Setting 1 delivers the lowest amount of oxygen and setting 5 provides the highest. Minute volumes for each setting and oxygen concentration are listed in the device specifications. Oxygen minute volume is controlled electronically by monitoring the user's breath rate. By monitoring the user's breath rate the device is able to provide the patient the same amount of oxygen per minute.

The EasyPulse POC offers the user multiple options to power the device. The device includes an internal Lithium-Ion battery, not accessible by the patient, that will provide varying runtimes dependent upon the setting chosen. Stated battery runtimes are listed in the specifications. An external AC/DC power supply is included with the device. The external AC/DC power supply allows the user to power the device from a standard 110 VAC outlet. An external DC/DC automobile adapter is also provided with the device. The external DC/DC automobile adapter allows the user to power the device from a standard 12V automobile accessory jack. When connected to either the AC/DC power supply or external DC/DC automobile adapter, the device will default to charging the internal battery when the unit is in the OFF position. If the unit is turned on while connected to either of the above, the device will simultaneously run (provide oxygen) and charge the internal battery.

The provided text describes a 510(k) submission for the Precision Medical EasyPulse portable oxygen concentrator (Model PM4150). However, it does not contain information about a study proving the device meets specific acceptance criteria in the manner typically seen for medical imaging or AI-driven diagnostic devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device and lists various performance and safety tests conducted to show the device's functionality and adherence to relevant standards. There is no mention of "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy that would be relevant to an AI-driven device or a device requiring expert review for ground truth.

Therefore, I will interpret "acceptance criteria" as the reported specifications and "study" as the performance testing conducted to verify these specifications, as described in the provided document.

Here's the breakdown of the information based on your request, with explicit statements where requested information is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a portable oxygen concentrator and not an AI/diagnostic device, the "acceptance criteria" refer to the device's technical specifications and the "reported device performance" are the measurements taken during testing to confirm these specifications.

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

• Sample size: Not specified. The document refers to "test units" but does not give a specific number.
• Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Precision Medical, Inc. The nature of the device (a physical medical device) suggests these are laboratory and engineering tests, not involving human patient data in the context of clinical trials to establish efficacy for a diagnosis.

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

• Not applicable / Not provided. The device is a portable oxygen concentrator, not an AI-driven diagnostic tool that would require expert-established ground truth for a test set in the conventional sense (e.g., radiologist review of images). The "ground truth" for this device's performance is derived from physical measurements and adherence to technical specifications and regulatory standards.

4. Adjudication method for the test set

• Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth in diagnostic tasks. This is not relevant to the described performance testing of an oxygen concentrator.

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 provided. An MRMC comparative effectiveness study is exclusively relevant to AI-assisted diagnostic tools and does not apply to a portable oxygen concentrator.

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

• Not applicable / Not provided. The device is a physical medical device. There is no "algorithm only" performance reported in the context of diagnostic AI. Its "standalone" performance refers to its ability to meet its technical specifications independently, which is what the listed performance tests address.

7. The type of ground truth used

• The "ground truth" for this device's performance is physical measurement against established engineering specifications and regulatory standards. For example, oxygen concentration is measured by an appropriate sensor, and sound level by a sound level meter. There is no ground truth based on expert consensus or pathology in the context of a diagnostic outcome.

8. The sample size for the training set

• Not applicable / Not provided. This device is a hardware product, not a machine learning model, so there is no training set in the AI sense.

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

• Not applicable / Not provided. As there is no training set mentioned in the context of AI, this question is not relevant to the provided information.

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The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.

The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.

The provided document is a 510(k) summary for the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit. It does not contain the detailed performance study information typically associated with AI/ML-based medical devices or diagnostic tools that would have "acceptance criteria" and "reported device performance" in the way an AI model would be evaluated.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Precision Medical 2200 liquid oxygen system K041122) and the results of general performance and mechanical/climatic testing.

Therefore, I cannot directly provide answers to all the requested categories, as they are not applicable to the type of device and submission described. However, I can extract the relevant information from the document as it pertains to the device's validation.

Here's a breakdown of what can be extracted and what cannot:

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

• The document states: "The Precision Medical, Inc. Easy Mate 6+6 has successfully passed tests in the following areas; Mechanical / Climatic, Device Performance."
• It does not provide a table with specific quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy, duration of oxygen delivery under certain conditions) or corresponding measured performance values. This type of detail is usually found in the full 510(k) submission, not the summary.
• Acceptance Criteria (General): The device functions as intended to deliver supplemental oxygen at set rates.
• Reported Device Performance (General): The device successfully passed mechanical/climatic and device performance tests.
• Specifics of Acceptance Criteria/Performance: Not provided in this summary.

Applicability of other questions for this type of device:

The remaining questions (2-9) are typical for the evaluation of AI/ML algorithms or diagnostic devices where "ground truth" establishment, expert review, and statistical analysis of performance against a reference standard are critical. For a purely mechanical device like a portable liquid oxygen unit, these concepts are not directly applicable in the same way.

• No "test set" in the context of images or patient data for AI.
• No "experts" establishing ground truth for disease presence.
• No "adjudication method."
• No "multi-reader multi-case (MRMC) comparative effectiveness study" as there's no human interpretation component to be assisted by AI.
• No "standalone" algorithm performance study.
• No "ground truth" in the diagnostic sense (pathology, outcomes data). The "ground truth" for this device would be its ability to physically deliver oxygen accurately and safely, validated through engineering and functional tests.
• No "training set" as this is a mechanical device, not an AI model.

Summary based on the provided text for a general medical device, not an AI/ML device:

The document describes the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit.

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

(Note: Specific quantitative values for criteria and performance are not included in this 510(k) 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. This device undergoes engineering and functional testing, not a clinical "test set" in the diagnostic data sense. Details on the number of units tested are not in this summary.

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. The "ground truth" for this mechanical device is established through engineering specifications and verified by technical testing, not through expert interpretation of data.

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

• Not applicable. No expert adjudication process is described for this type of device validation.

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 mechanical device, not an AI-assisted diagnostic tool for human interpretation.

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

• Not applicable. There is no algorithm or AI component in this mechanical device.

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

• Engineering/Functional Specifications: The "ground truth" for this device would be its adherence to established engineering specifications for oxygen production, flow rates, pressure regulation, and mechanical durability. This is verified through direct measurement and physical testing.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set."

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

• Not applicable. See point 8.

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The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.

The blender is not intended as a life supporting device.

The Precision Medical, Inc. Heliox/oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of Heliox/oxygen mixtures are required.

The provided 510(k) summary for the Precision Medical, Inc. HeliO2 Blender does not contain a study that proves the device meets specific acceptance criteria in the way described in your request.

This document is a premarket notification (510(k)) submission to the FDA. For this type of device (a medical gas blender), "proving acceptance criteria" typically involves demonstrating substantial equivalence to a predicate device, as well as meeting recognized performance standards for medical gas blenders. The submission focuses on comparison to a predicate device and outlines the device's technical specifications and intended use, rather than presenting a performance study with detailed acceptance criteria and results against those criteria.

Here's an breakdown of the information available and what is not present, based on your request:

1. Table of acceptance criteria and the reported device performance

The document provides a table comparing the Heliox/oxygen blender to its predicate (air/oxygen blender) for various specifications. These specifications act as de facto acceptance criteria for functional performance, largely demonstrating equivalence or improvement compared to the predicate.

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

This information is not provided in the summary. For a medical device like a blender, "test set" would typically refer to the various configurations and conditions under which the device was tested (e.g., different flow rates, oxygen percentages, inlet pressures, gas mixtures). The document only states the specifications; it does not detail the testing methodology, number of test runs, or data provenance.

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 and not provided for this type of device. "Ground truth" established by experts, especially clinical experts, is relevant for AI/diagnostic devices where human interpretation is involved. For a mechanical medical gas blender, performance is measured against engineering specifications, not expert consensus on an image or diagnosis.

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

This is not applicable and not provided. Adjudication methods are used in studies where there is subjective assessment or disagreement, typically in diagnostic or imaging trials. Performance of a medical gas blender is measured objectively using calibrated instruments.

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 and not provided. MRMC studies are used for evaluating diagnostic systems where human readers interpret medical cases, often with and without AI assistance. This device is a mechanical blender, not a diagnostic tool requiring human interpretation of cases.

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

This is not applicable and not provided. "Standalone" performance testing relates to AI algorithms. This device is a mechanical blender and does not involve algorithms in the sense of AI. Its performance is inherent to its mechanical design and operation.

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

For this device, the "ground truth" for its performance would be objective engineering measurements from calibrated test equipment, adhering to relevant standards for medical gas blenders (e.g., flow meters, oxygen analyzers, pressure gauges). This is implied by the listed specifications but not explicitly detailed as "ground truth" in the provided text.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train AI models. This device is a mechanical product, not an AI system.

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

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

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the HeliO2 Blender to a predicate oxygen blender through a comparison of their technical specifications and intended use. It does not present a "study" in the typical clinical or AI sense, but rather relies on the device meeting established engineering performance criteria consistent with or better than the predicate device. The detailed methodological aspects of a performance study (like sample size for test sets, expert involvement, adjudication, or training sets) are not included in this type of regulatory submission for a mechanical device.

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The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.

Precision Medical, Inc. Concentrator is a medical device that produces concentrated oxygen from room air. The concentrator uses a molecular sieve and a pressure differential absorption process to concentrate oxygen from air.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study conducted to prove the device meets those criteria:

Acceptance Criteria and Device Performance

Note: For "Flow accuracy," "Storage temperature," "Weight," "Sound level," "Outlet pressure," and "Back pressure," the acceptance criteria were inferred from the reported performance of the Precision Medical device, as the table presents them as if the Precision Medical performance is the criteria for meeting the requirement within its own column.

Study Information

Based on the provided text, the study focuses on technical performance testing rather than a clinical study involving human subjects or expert assessment of data.

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

   • The document does not specify a "sample size" in terms of cases or patients for a test set. The tests described are for the device itself (e.g., mechanical, climatic, life test, alarm testing).
   • Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal testing of the Precision Medical, Inc. Oxygen Concentrator. It is a prospective study in the sense that the tests were specifically conducted on the manufactured device.

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

   • Not applicable. The ground truth for this device is based on objective measurements against engineering specifications and regulatory standards (like ISO 8359:1996 and 60601-1). No human "experts" are establishing a subjective "ground truth" for interpretation of data in the way radiologists establish ground truth for medical images. The measurements themselves are the ground truth.

3. Adjudication method for the test set:

   • Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The device's performance is objectively measured.

4. 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 MRMC comparative effectiveness study was done. This document describes the technical performance testing of a medical device (oxygen concentrator), not an AI-powered diagnostic or assistive tool for human readers.

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

   • The entire performance evaluation reported is a "standalone" evaluation of the device itself (the oxygen concentrator). There is no "algorithm" in the sense of AI being evaluated here, but the device's functional performance criteria are tested without human intervention impacting its core operation.

6. The type of ground truth used:

   • The ground truth is based on engineering specifications, objective measurements, and compliance with recognized standards (e.g., ISO 8359:1996, 60601-1 Section 10.1). For example, oxygen percentage is measured and compared to the 93% ±3% specification.

7. The sample size for the training set:

   • Not applicable. This is a medical device (oxygen concentrator) whose performance is evaluated against physical and functional specifications. It does not involve machine learning or a "training set" for an algorithm.

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

   • Not applicable, as there is no training set mentioned or implied for this device's evaluation.

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The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.

The Precision Medical, Inc. Oxygen monitor is made of two components, the monitor, and the sensor, attached by a coiled cable. The monitor houses the LCD screen, circuit board, key pad, and batteries. The sensor is a galvanic oxygen sensor that produces a millivolt signal that is proportional to partial pressure of oxygen being measured. The monitor converts the millivolt signal sent from the sensor to a percent oxygen concentration displayed on the LCD screen.

Here's a breakdown of the acceptance criteria and the study information for the Precision Medical, Inc. Oxygen Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only lists the tests performed.

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

This information is not provided in the document. The tests performed are engineering and performance validation tests on the physical device itself (e.g., accuracy, temperature range), not on interpretations by experts.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are technical performance measurements of the device, not analyses requiring expert adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The device is an oxygen monitor, which provides a direct measurement, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a physical oxygen monitor, not an algorithm. Its performance is inherent to its physical and electronic design. The data provided describes standalone device performance.

7. Type of Ground Truth Used

The ground truth used for these performance tests would be calibrated reference standards or known environmental conditions. For example, for "Accuracy & Linearity," the ground truth would be precisely measured oxygen concentrations and controlled temperature/humidity. For "Electromagnetic Emissions & Immunity," the ground truth would be established by the testing standards themselves.

8. Sample Size for the Training Set

This is not applicable as the Precision Medical, Inc. Oxygen Monitor is a hardware device that measures oxygen concentration using a galvanic fuel cell. It does not employ machine learning or AI models that require a training set.

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

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

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The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.

The Precision Medical, Inc. Air and Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required.

The provided text describes the Precision Medical, Inc. Blender, an oxygen blender, and its substantial equivalence to a predicate device (Bio-Med Blender). The document explicitly lays out performance specifications for the device and a summary of performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The "Reported Device Performance" column directly reflects the specifications of the Precision Medical, Inc. Blender, which are stated to be equivalent to the predicate device. The document affirms that "The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance."

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

The document states, "The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in technical reports that would accompany such a submission but is not present in this summary.

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

This device is an oxygen blender, which is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment. Therefore, this section is not applicable. The performance is measured against established physical and mechanical parameters.

4. Adjudication method for the test set

As this is a mechanical device, performance is evaluated against defined physical and operational specifications using measurement tools, not through human interpretation or adjudication. Therefore, an adjudication method is not applicable.

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 device is an oxygen blender, not an AI-assisted diagnostic or interpretive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study is not applicable.

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

This question is related to AI/algorithm performance. The Precision Medical, Inc. Blender is a purely mechanical device. Therefore, this is not applicable.

7. The type of ground truth used

For the Precision Medical, Inc. Blender, the "ground truth" for performance evaluation is based on defined engineering specifications and measurable physical/mechanical parameters (e.g., oxygen concentration, flow rates, pressure differentials, alarm intensity, temperature range). These are objective measurements rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This device is not an AI/machine learning system that requires a "training set." Its design and performance are based on engineering principles and physical testing. Therefore, this is not applicable.

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

As there is no training set for this mechanical device, this is not applicable.

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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 Precision Medical, Inc. Liquid Oxygen System is intended to provide supplemental oxygen to oxygen patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 4 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.

The Precision Medical, Inc. Liquid Oxygen system consists of a vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid oxygen reservoir,where it is filled by a connection that allows the portable device to be filled by the larger reservoir. The Precision Medical Inc System is a mechanical device containing no electrical components.

The provided document is a 510(k) summary for a medical device (Precision Liquid Oxygen System) and does not contain information about a study with acceptance criteria and reported device performance metrics in the format requested.

It's a regulatory submission demonstrating substantial equivalence to a predicate device, not a performance study report with detailed statistical analysis as might be found for AI/ML devices.

Here's why the requested information cannot be fully provided based on the input:

• Type of Device: The Precision Medical, Inc. Liquid Oxygen System is a mechanical device with no electrical components. The questions in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) are highly relevant to AI/ML device evaluations, not mechanical medical devices like this one.
• Nature of "Performance Testing" described: The document states, "The Precision Medical, Inc. Liquid Oxygen System successfully passed tests in the following areas: Mechanical / Climatic Device Performance." This indicates physical and environmental testing typical for mechanical devices, not diagnostic or clinical performance metrics measured against ground truth with statistical analysis.
• Absence of Specific Data: There is no table of acceptance criteria with corresponding reported device performance values, no sample sizes for test sets, no details on ground truth establishment, no mention of experts, or any of the other AI-related study parameters.

Therefore, I cannot directly populate the requested table and detailed study information based on this document. The document confirms that performance testing was done but only provides a very high-level summary that it "successfully passed" mechanical and climatic performance tests, without specifying the criteria or the quantitative results.

If this were an AI/ML device, the detailed study information would typically be present in a much more extensive clinical or performance study report.

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