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The Invacare® Perfector™V Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare® Perfecto2™V Oxygen Concentrator. The subject device is used by patients who require supplemental oxygen concentration level of the output gas ranges from 87% to 95.6% at an output flow rate range of 1/2 to 5 liters per minute. The oxygen is delivered to the user through the use of a nasal cannula.

This document is a 510(k) Premarket Notification for the Invacare Perfecto2V Oxygen Concentrator. It asserts substantial equivalence to a predicate device, the Invacare Platinum 5 Oxygen Concentrator (K020386), rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of a new functional claim (e.g., related to AI performance).

Therefore, I cannot extract the information required for the requested table and study details (acceptance criteria, performance, sample sizes, expert involvement, adjudication, MRMC, standalone, ground truth, training set specifics) because the provided text describes a submission for a medical device (oxygen concentrator), not a software/AI device that would involve the assessment of algorithmic performance against a ground truth.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to a previously cleared predicate device.
• Bench Testing: Performance testing (e.g., oxygen concentration levels, flow rates, electrical safety, biocompatibility) to show the device meets its defined specifications and is equivalent to the predicate.
• Risk Management and Software Verification: Ensuring the device's design and software meet relevant standards.

There is no mention of an AI component, image analysis, human reader studies, or any of the elements typically associated with the kind of "acceptance criteria" and "study" described in your prompt, which are relevant to diagnostic or AI-driven medical devices.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of AI or sophisticated diagnostic performance.

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The Invacare TPOC Portable Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare TPOC Portable Oxygen Concentrator can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC Portable Oxygen Concentrator does not nor is it intended to sustain or support life.

The Invacare TPOC is to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institution, vehicle and various mobile and outdoor environments. The device is not intended to sustain or support life. The device is typically used with a nasal cannula to direct oxygen from the device to the patient.

When set for Continuous Flow Mode, the TPOC can deliver up to 3 LPM continuous flow in 0.5 LPM increments. While in Pulse Delivery Mode, when the demand for oxygen is detected, the oxygen is delivered through pulsed flow with pulse flow settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6% in all modes.

The modified TPOC contains an integrated oxygen sensor to provide added monitoring of the output gas purity, as well as additional patient warnings and alarms based on those levels. The oxygen sensor process uses a heated Zirconia element as the method of measurement. This is the exact same sensor process used in previously cleared oxygen concentrators such as the Invacare Platinum 5 Oxygen Concentrator, K020386.

With the addition of continuous flow, the TPOC is now capable of supporting two features commonly with the addition of ocultified no ne nextrators; usc with a humidification and use in conjunction with PAP, Bi-Level and other such devices as an oxygen bleed-in. The use of this equipment is only during continuous flow mode, as indicated in the User's Manual. odulphileit is only aaning othium battery pack, standard power options include switching power Anong with a rents from AC power outlet (120 VAC/ 60 Hertz nominal) and from accessory DC outlets typically found in a mobile vehicle type environment (12 VDC nominal).

The Invacare TPOC uses a molecular sieve and pressure swing adsorption methodology to produce the The in theater Tr C abber a nair enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath in pulse mode. In continuous flow mode, the operation is the same with the exception that the oxygen is delivered continuously, without the need for breath detection.

The basic technology of the Invacare TPOC is equivalent to its predicate device.

This document describes the Invacare Transportable Oxygen Concentrator (TPOC, Model TPOC100) and its 510(k) summary, which essentially acts as a claim for substantial equivalence to a predicate device, the Invacare Flyer Oxygen Concentrator (K0719028).

There is no detailed study provided within the given text that explicitly describes acceptance criteria and then presents study results to prove those criteria were met for the Invacare TPOC.

The document states: "Performance Testing: The performance testing conducted as a result of the modifications to the Invacare Flyer, as required by the risk analysis, was performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not provide the specifics of these acceptance criteria or the study details.

Based only on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" are implied by the performance characteristics listed for the device itself and against its predicate. The text explicitly states that "Performance Testing... was performed and the results demonstrated that the predetermined acceptance criteria were met," but it does not list those specific criteria or the detailed results of the tests. The table above largely compares the TPOC's specifications to the predicate and notes its own specifications as the "reported device performance."

Regarding the study proving the device meets the acceptance criteria:

The provided text only makes a general statement about performance testing, rather than describing a specific study with detailed methodology. Therefore, most of the following information is missing from the input text:

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

• Missing. The document does not specify any sample size for a test set or the provenance of data. The "performance testing" mentioned is generic.

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 / Missing. This device is an oxygen concentrator, not an imaging or diagnostic device that would typically rely on expert human interpretation for ground truth establishment. Therefore, there would not be "experts" establishing ground truth in this context, but rather engineering/technical verification against specifications.

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

• Not applicable / Missing. As above, this concept typically applies to studies where human reviewers are assessing data (e.g., medical images) and their agreement is critical for ground truth. It's not relevant to the performance testing of a physical medical device like an oxygen concentrator against its specifications.

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. This is not an AI-assisted diagnostic or interpretive device. An MRMC study would not be applicable to an oxygen concentrator.

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

• Not applicable. This isn't an algorithm; it's a hardware device with embedded software. Its performance would inherently be "standalone" in terms of its mechanical and electronic functions. The "standalone" concept typically applies to pure AI/algorithm performance.

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

• Inferred: The "ground truth" for oxygen concentrators meeting performance criteria is based on direct physical measurements against engineering specifications and validated test methods (e.g., oxygen concentration using a sensor, flow rate measurement, weight measurement, battery life tests, safety tests). The document mentions an integrated oxygen sensor and "predetermined acceptance criteria" from risk analysis, which implies such direct measurements.

8. The sample size for the training set

• Not applicable/Missing. This device does not use a "training set" in the context of machine learning or AI. Performance testing involves demonstrating the device meets its specifications, not training an algorithm.

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

• Not applicable/Missing. No training set is involved for this type of device.

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The intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

The Drive Solstice Oxygen Concentrator is a PSA (Pressure Swing Adsorption) system Oxygen Concentrator, the output of oxygen is 1 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of the adsorption material -molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed top. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the top of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Drive Solstice Oxygen Concentrator:

The provided document is a 510(k) summary for the Drive Solstice Oxygen Concentrator. It primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against pre-defined acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and sample sizes for testing and training sets is not explicitly present in this type of regulatory submission.

The document argues that the device meets acceptance criteria by demonstrating that it is substantially equivalent to a legally marketed predicate device (Zhongshan A&J Medical Equipment Co., Ltd's A&J-POCA01 Oxygen Concentrator - K071608). The underlying assumption is that if the predicate device met its acceptance criteria and the proposed device is equivalent, then the proposed device also meets those implied criteria.

Let's break down what can be inferred or is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria." Instead, it presents a comparison of specifications between the proposed device and two predicate devices. The acceptance criteria are implicitly the performance characteristics of the predicate device, which the proposed device must meet or be comparable to.

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

• Sample Size: Not applicable/not provided. This document does not describe a performance testing study with a "test set" in the traditional sense of a clinical or image-based AI study. The "test" here is a comparison of specifications to a predicate device.
• Data Provenance: Not applicable/not provided. The document states "Medical Depot claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K071608." This implies the "data" is the set of specifications published or known for the predicate devices. There is no mention of country of origin for any new test data or whether it was retrospective or prospective, as no such new test data is presented for this device.

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

• Number of Experts: Not applicable/not provided. There is no mention of experts establishing ground truth for a test set, as no such test set or study is described. The "ground truth," in this context, is the established performance and safety of the predicate device, which the FDA has already cleared based on its own review.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not provided. No test set requiring expert adjudication is described in the 510(k) summary.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is typically associated with AI/medical imaging devices, assessing human reader performance with and without AI assistance. The device in question is an oxygen concentrator, a physical medical device, not a diagnostic AI tool.
• Effect Size: Not applicable.

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

• Standalone Study: No, a standalone algorithm-only performance study was not done or described. This concept is most relevant for AI algorithms. For a physical device like an oxygen concentrator, performance is measured against its technical specifications (e.g., oxygen purity, flow rate, alarms). While the manufacturer would have performed internal testing to ensure the device met its specifications, this 510(k) summary does not detail those specific test results or methodology; instead, it relies on substantial equivalence.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" implicitly used in this 510(k) submission is the established performance and safety of the legally marketed predicate device(s), specifically the Zhongshan A&J A&J-POCA01 Oxygen Concentrator (K071608). The manufacturer is asserting that their device is essentially identical in form, function, and materials, and therefore shares the same "truth" of being safe and effective.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not provided. This concept applies to machine learning models. The Drive Solstice Oxygen Concentrator is a physical device, not an algorithm that requires a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable/not provided. As the device is not an AI algorithm, there is no training set or ground truth associated with it in that context.

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The LFY-I-5 Oxygen Concentrators are indicated fro the administration of supplemental oxygen. The LFY-I-5 Oxygen Concentrators are not intended for life support nor does it provide any patient monitoring capabilities.

The Longfei Model LFY-I-5 Oxygen concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life. Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired. The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch. The LFY-I-5 Oxygen concentrator is a 5-liter per minute oxygen concentrator that is of the pressure swing adsorption (PSA) type. The pneumatic system consists of 5 major components: inlet filtration, air compressor and heat exchanger, synthetic Zeolite molecular sieve beds and distribution value module, outlet filtration, and flow meter. The electrical system consists of AC power distribution to the air compressor and a motor with gear reduction used to drive the distribution valve; the unit is double insulated and uses a two-conductor power cable. Device monitoring circuit are included that monitor oxygen concentration. In the event of a malfunction, the unit will shut down and activate visual.

The provided document is a 510(k) summary for a medical device (Oxygen Concentrator), and therefore it does not contain the level of detail typically found in a clinical study report regarding acceptance criteria, performance metrics, and study design elements like sample size, ground truth establishment, or expert qualifications.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific clinical acceptance criteria through a standalone study.

Here's what can be extracted and what cannot based on the provided text:

Acceptance Criteria and Device Performance:

The document indicates that the device "complies with the ASTM Standard Specifications for Oxygen concentrators for Domiciliary Use (Anesthesia) and the ISO standard 8359: 1996, Oxygen concentrators for Medical Use (Anesthesia)."

Compliance with these standards implicitly means meeting the performance criteria outlined within them. However, the document does not explicitly list the specific quantitative acceptance criteria or the reported device performance values against those criteria. It states that "Conformance or variance with these standards is described on the following pages," but those pages are not included in the provided text.

Therefore, a table of explicit acceptance criteria and reported device performance cannot be created from this document. The "device performance" in this context is the general statement of compliance with the mentioned standards.

Regarding the study proving the device meets acceptance criteria:

The document does not describe a specific clinical study designed to prove the device meets acceptance criteria in the manner usually associated with a standalone performance study. The 510(k) process for this type of device relies on demonstrating equivalence to a predicate device and compliance with recognized standards through engineering tests, rather than a prospective clinical trial with human subjects.

Given the nature of the device (an oxygen concentrator) and the regulatory pathway (510(k)), the "study" likely refers to bench testing and engineering verification to ensure the device meets the specifications outlined in the ASTM and ISO standards it claims to comply with.

Information that cannot be provided from the text:

The following information cannot be found in the provided 510(k) summary:

• Sample sized used for the test set and the data provenance: Not applicable in the context of this 510(k) submission, which relies on engineering and performance testing against standards rather than a clinical "test set" with human data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an oxygen concentrator's performance would be established through calibrated instruments and engineering measurements, not expert consensus on clinical data.
• Adjudication method: Not applicable.
• 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 completely irrelevant for an oxygen concentrator, which is not an AI-powered diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm-based device. Its performance is inherent in its electromechanical function.
• The type of ground truth used: As mentioned, ground truth would be based on precise physical measurements (e.g., oxygen concentration, flow rate) using calibrated equipment, not pathology, expert consensus, or outcomes data in the clinical sense.
• The sample size for the training set: Not applicable, as this is an electromechanical device, not a machine learning model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary based on the document:

The provided document, a 510(k) summary for an oxygen concentrator, indicates the device's compliance with established industry standards (ASTM and ISO). This compliance is the primary "proof" of its performance as required for 510(k) clearance. The document does not describe a clinical study or provide specific quantitative performance data or details about study design elements typically associated with clinical trials of diagnostic or AI-enabled software devices.

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