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The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.

The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its operation with air being pulled into the external air intake filter. This filtered air enters the compressor via a suction resonator and fine filter. Pressurized air then exits the compressor. Next, an electronic valve system directs the air into one of two tubes that contain molecular sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the nitrogen from the air as it is pushed through the sieve beds, this process is called pressure swing adsorption (PSA). As one tube is generating the product gas, the other is being purged of the adsorbed nitrogen. After passing through the oxygen storage tank, the rate of product gas being delivered to the patient is set by a restricting orifice and pulse dose valve based upon detection of a breath. It then passes through a fine particle filter and thru a sensor that detects the oxygen concentration of the product gas before it exits the device through a fire-resistant outlet. Once the product gas leaves the device, it travels to the patient via oxygen tubing and a cannula inserted in the nose. The Nano POC offers the user multiple options to power the device; a detachable lithium ion battery, replaceable by the patient, and an external AC/DC power supply. The device will charge the lithium ion battery when the battery and power supply are both attached. The device operates from 100V to 240V and at 50/60Hz. The device is approximately 8.3″ wide by 3.5″ deep by 6.5″ high (21.6cm x 8.9cm x 16.5cm). The device weighs about 4.7 pounds (2.1 kg) including the battery. The device provides an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy without the higher cost of bottled oxygen. The device produces a product pressure of less than 170 kPa (25 psig) and flow is set by a controller that delivers pulsed flow rates nominally equivalent to continuous flow rates of 1 to 5 LPM. The device provides pulsed dose delivery of oxygen to the user through a selection of 5 settings; setting 1 delivering the least and setting 5 delivering the greatest amount of oxygen enriched product gas. Oxygen pulse volume per minute is controlled electronically by monitoring the user's breath rate and therefore adjusting bolus volume to deliver the same amount of oxygen per minute to the user. The device does not contain, nor does it produce, any latex, phthalates, harmful chemicals, animal tissue, blood components, or radioactive materials that the user or patient could physically contact. The user has short term surface contact with the device (PC + ABS cabinet and PET HMI overlay), but the nasal cannula has contact with the face for the duration of the treatment. The product gas also has prolonged contact with the respiratory airways. The device is not invasive nor implanted. The device is not life supporting, life sustaining, sterile, or radioactive. The device does not incorporate a medical substance, animal tissue or blood component. The device is reusable and should be used as often as prescribed, for the duration prescribed. Smoking cigarettes while undergoing treatment, especially during treatment, is a contraindication to the intended purpose of the device. Nidek Medical Products, Inc. warns against the use of oil or grease, using the device around an open flame, and using the device without a prescription from a doctor.

The provided text describes the acceptance criteria and the studies performed for the Nidek Medical Products, Inc. Nuvo Nano Portable Oxygen Concentrator (POC).

1. Table of Acceptance Criteria and Reported Device Performance:

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The modified devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The modified devices are substantially equivalent to the predicate devices. Modifications were made to improve reliability, ease of assembly and serviceability The compressor was changed from a vertically oriented tension spring supported configuration to a horizontally oriented compression spring supported configuration to minimize damage from shipment and handling. The cabinet back was changed from a single part to two parts to simplify assembly and serviceability. Labeling was changed to increase type size for improved readability and to correct some clerical errors. The motor run capacitor was changed to a type that includes an internal protective device. The device circuit breaker was changed from a 10 A rating to a 5 A rating. The modified devices continue to be AC powered devices that provide a high level of inspired oxygen, using the same method as that of the predicate devices, by separating oxygen from ambient air with the pressure swing adsorption (PSA) process. Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The modified device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg.]. The device is available in both 115V and 230V models. The device status indicators are the same as in the predicate devices: They are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure. The modified device is not life supporting, life sustaining or sterile. The modified devices may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. Recommended accessory devices are described in the User's Guide. One of these devices may optionally be included with the device.

The provided document is a 510(k) summary for the Mark 5 Nuvo Lite OCSI and Mark 5 Nuvo Lite STD oxygen concentrators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study against predefined metrics.

Therefore, most of the requested information (items 1-9) regarding acceptance criteria and a study to prove meeting those criteria is not directly applicable or available in this 510(k) summary. The summary details modifications made to existing predicate devices and argues for substantial equivalence based on technological characteristics and non-clinical performance (bench testing against relevant standards).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit "acceptance criteria" in the traditional sense of a clinical trial or performance study with numerical targets. Instead, it compares the modified devices' characteristics to those of the predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it matches or is within an acceptable range of the predicate device's performance, along with meeting certain non-clinical standards.

Notes on the "Acceptance Criteria" column: For a 510(k) demonstrating substantial equivalence, the "acceptance criteria" are generally that the modified device performs comparably to the predicate device, or that any differences do not raise new questions of safety or effectiveness. The values listed in the "Predicate Devices" column serve as the benchmark for comparison.

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

• Sample Size: Not applicable. This summary presents engineering and design changes and bench testing results, not a study with a "test set" of patients or clinical data. The "test set" implicitly refers to the modified device prototypes and components during iterative development and verification.
• Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the non-clinical testing against standards.

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

• Not applicable. As this is a 510(k) for device modifications and substantial equivalence, there is no mention of experts establishing a "ground truth" for a clinical test set. The determination of substantial equivalence is made by regulatory bodies (FDA) based on the submitted technical documentation and performance data against established standards and predicate devices.

4. Adjudication Method:

• Not applicable. No clinical test set or expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. These are oxygen concentrators, not diagnostic imaging devices where MRMC studies are common to assess human reader performance with and without AI assistance.

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

• Not applicable. These are medical devices with mechanical and electronic components, not AI algorithms. Performance testing focuses on the physical device's specifications (e.g., oxygen concentration, flow rate, safety features) rather than algorithm standalone performance.

7. The Type of Ground Truth Used:

• Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is adherence to engineering specifications, safety standards (ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90), and comparability to the predicate device's established performance characteristics.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or AI algorithms requiring training sets.

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

• Not applicable, as there is no training set for an AI algorithm.

Summary of the Study provided:

The "study" presented in this 510(k) is a non-clinical performance evaluation and comparison report. The manufacturer conducted various tests to ensure the modified devices continued to meet relevant safety and performance standards and were substantially equivalent to their predicate devices despite the changes.

• Non-Clinical Performance: "The device was tested to applicable requirements ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 + A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, and FDA Reviewer Guidance document 'Excerpts Related to EMI from November 1993' as appropriate to the area of usage."
• Conclusion: "The modified devices include all the same or similar materials, operate with the same technology and demonstrate the same performance so are substantially equivalent to the legally marketed predicate devices."

This indicates that various bench tests and measurements were performed to verify that changes to components (compressor, capacitor, circuit breaker, etc.) did not negatively impact the overall performance (e.g., oxygen concentration, flow rate, noise level, operating ranges) or safety of the device when compared to the established performance of the predicate device and relevant industry standards.

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The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

Mark 5 Nuvo 8 OCSI
Mark 5 Nuvo 8 STD

I'm sorry, but this document does not contain the information requested. This is an FDA 510(k) clearance letter for the Mark 5 Nuvo 8 OCSI and Mark 5 Nuvo 8 STD portable oxygen generators. It states that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. However, it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any information related to AI or MRMC comparative effectiveness studies. This type of information would typically be found in the 510(k) submission itself, not the clearance letter.

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The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The proposed device is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The proposed device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg]. The device is available in both 115V and 230V models.

The device status indicators are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure.

The proposed device is not life supporting, life sustaining or sterile.

The proposed device may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

The provided text describes a 510(k) summary for the Mark 5 Nuvo Lite OCSI and Mark 5 Nuvo Lite STD oxygen concentrators. The information primarily focuses on regulatory approval, device description, and substantial equivalence to predicate devices, rather than a detailed study reporting acceptance criteria and device performance in the manner typically seen for clinical outcome-based or AI/software device studies.

Therefore, many of the requested categories for a study proving device performance are not explicitly detailed in the provided documents.

Here's an analysis based on the available information:

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

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

The provided document describes nonclinical performance testing primarily focused on compliance with recognized standards (ISO, EN, IEC, UL, CAN/CSA, FDA guidance for EMI). It does not detail specific "test sets" or "data provenance" in the context of clinical studies with patient data. The testing mentioned would involve laboratory-based assessments of device specifications and safety standards, rather than tests on a "sample size" of patients or patient 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)

Not applicable. The document describes testing against engineering specifications and regulatory performance standards, not against expert-established ground truth from clinical data.

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

Not applicable. This type of adjudication is relevant for interpreting clinical data, particularly in medical imaging or diagnostic contexts. The testing here is for engineering performance and regulatory compliance.

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. The device is an oxygen concentrator, not an AI or diagnostic software.

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

Not applicable. The device is physical hardware (an oxygen concentrator), not a software algorithm.

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

The "ground truth" for this device's performance is based on engineering specifications, direct measurements of oxygen concentration and flow rate, and compliance with established national and international safety and performance standards for medical electrical equipment and oxygen concentrators. There is no biological "ground truth" in the clinical sense mentioned.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning. The design and validation are based on engineering principles and regulatory standards.

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

Not applicable.

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The Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The proposed device is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%. The oxygen concentration status indicator (OCSI) board controls the device status indicators including an operator alert when the oxygen concentration in the product gas is below the set point. It is not a life-supporting, life-sustaining or sterile device.

The proposed device is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999, ISO 8359 and FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage.

The proposed device may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

The provided text is a 510(k) summary for the Nidek Medical Products, Inc. Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Mark 5 Nuvo Concentrator K032509) by detailing the device description, technological characteristics, and nonclinical performance (compliance with various electrical and safety standards).

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Details about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
• The type of ground truth used, sample size for the training set, or how ground truth was established for the training set.

The core of this 510(k) is that the proposed device is "exactly the same as the predicate device except the board configuration was modified to incorporate an oxygen concentration status indicator (OCSI)." The performance claims revolve around the device providing a "nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%" and the OCSI board controlling a "operator alert when the oxygen concentration in the product gas is below the set point." However, it does not present a specific study with defined acceptance criteria to quantitatively prove these performance metrics in the way your request describes. It primarily relies on compliance with existing safety and electrical standards and the substantial equivalence to the predicate device.

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The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90 ±3% at a flow rate of 5 l/min ±10%. It is not a life-supporting, life-sustaining or sterile device.

The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.

Here's a breakdown of the acceptance criteria and the study information for the Nidek Medical Products, Inc. Mark 5 Nuvo (M5C5) Oxygen Concentrator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Nidek Mark 5 Nuvo (M5C5) Oxygen Concentrator primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and their direct fulfillment in a table. However, we can infer some key performance metrics and the reported device performance from the "Device Description" section and the "Nonclinical Performance" section.

Note on Acceptance Criteria: It's important to understand that for a 510(k) submission, the primary "acceptance criterion" is generally substantial equivalence to a predicate device. This means the new device performs as safely and effectively as a legally marketed device. The performance specifications listed above are the design specifications that were likely established to meet the intended use and demonstrate equivalence, rather than explicitly stated "acceptance criteria" against which a study was formally tested and presented in a table in this summary.

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

The document does not explicitly state a "test set" in the context of clinical studies with a specific sample size. The performance testing conducted was nonclinical.

• Sample Size: Not applicable for a traditional test set involving patient data. The testing was performed on the device itself. The number of units tested is not specified but would typically involve one or more production or prototype units under various conditions.
• Data Provenance: The testing was nonclinical, conducted at Intertek Testing Services NA Inc. located at Duluth, GA. This indicates laboratory-based testing, not human subject data.

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

Not applicable. The testing was nonclinical and involved adherence to recognized safety and performance standards. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for nonclinical performance is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process for this nonclinical performance testing.

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

No. This document describes a 510(k) submission for an oxygen concentrator, which involves a nonclinical performance evaluation against recognized standards and a comparison of technological characteristics to a predicate device. MRMC studies are typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI's impact on their performance is being evaluated.

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

Yes, in a conceptual sense. The "Nonclinical Performance" testing was a standalone evaluation of the device's adherence to applicable safety and electrical standards. The device itself (the oxygen concentrator) was tested independently without human-in-the-loop performance being a relevant parameter for its primary function of producing oxygen.

7. The Type of Ground Truth Used

For the nonclinical performance testing, the "ground truth" was compliance with established international and national electrical, medical device safety, and electromagnetic compatibility standards (EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999).

For the substantival equivalence comparison, the "ground truth" was the performance and design of the predicate device (Mark-5 (M5C5) Concentrator, K883591, and Model 590 Oxygen Concentrator, K895141).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (an oxygen concentrator) and does not involve AI or machine learning algorithms that would require a "training set" of data in the computational sense.

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

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

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The Pulmo-Mist compressor is designed for use by adult or pediatric patients requiring aerosolized medications.
The Pulmo-Mist Nebulizer Compressor is intended to be used to supply a continuous positive pressure to a nebulizer device for the purpose of generating an aerosol medicine.

The Pulmo-Mist compressor is an electrically powered piston type compressor that provides approximately 6 I/min of air flow against a back pressure of 10 psig. It is designed to supply air to a small volume nebulizer. The package optionally contains a legally marketed small volume disposable nebulizer kit, specifically the Westmed "VIXONE®", manufactured by Westmed, Inc. and private labeled for distribution by Nidek Medical Products, in the original manufacturer's unopened package, Each such package includes a mouthpiece, a nebulizer, a connector tube and flexible air tubing and labeling. The nebulization particle size varies slightly depending on the nebulizer used and on the viscosity of the material being nebulized. When used with the VIXONE, the MMAD is approximately 1 µm with a saline solution. Other manufacturers of small volume nebulizers report similar values for similar flow rates.
The Pulmo-Mist compressor is a portable unit. It weighs approximately 3.2 pounds and has dimensions of 7.5 in w x 4.5 in h x 7.5 in d.

The provided text describes the 510(k) submission for the Nidek Medical Products, Inc. Pulmo-Mist Compressor (K020797). This device is a physical medical device (a compressor for nebulizers) and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance) are not applicable to this submission.

However, I can extract the acceptance criteria and the study performed related to its regulatory approval as a traditional medical device.

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

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

• Sample Size: Not specified as this is a physical device. The testing was likely conducted on a limited number of units of the Pulmo-Mist Compressor.
• Data Provenance: The device was submitted by Nidek Medical Products, Inc. in Birmingham, AL, USA. The testing was conducted in the context of US regulatory approval (FDA 510(k) process). It's a prospective evaluation of the manufactured device.

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. This is a physical device for which performance is measured against engineering specifications and industry standards, not against expert interpretation of data.

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

• Not applicable. Performance testing for this type of device does not involve 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 physical device, not an AI/ML system.

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)

• The "ground truth" for this device's performance is established by adherence to engineering specifications, electrical and mechanical safety standards (UL544, UL1431), and industry performance guidelines (FDA Reviewer Guidance for Home Use Respiratory Devices). Its functionality is assessed based on its ability to generate the specified airflow and pressure.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Study Description:

The study proving the device meets the acceptance criteria was a performance testing study conducted by Nidek Medical Products, Inc. (or a designated testing facility) on the Pulmo-Mist Compressor.

• Methodology: The device was assessed against specific benchmarks and standards.

  • Regulatory Guidance: The testing followed the Anesthesiology and Respiratory Devices Branch's "Reviewer Guidance for Home Use Respiratory Devices" (March 1992) and "Reviewer Guidance for Premarket Notification Submissions" (November 1993).
  • Safety Standards: Compliance with Underwriter's Laboratory (UL) standards UL544 (Medical and Dental Equipment) and UL 1431 (Personal Hygiene and Healthcare Appliances) was also a critical component.
  • Technical Equivalence: The submission also highlighted the technical equivalence of the Pulmo-Mist compressor to the legally marketed predicate device (Invacare Model IRC 1001 Env) by identifying common components and design principles (same motor supplier, similar enclosure, wiring, etc.).
  • Functionality: Performance aspects like airflow rate (approximately 6 L/min) and pressure (10 psig back pressure) were likely measured and verified. The nebulization particle size reference (approx. 1 µm MMAD with VIXONE and saline) is a characteristic of the nebulizer when used with the compressor, not directly the compressor itself, but implies the compressor provides adequate power for this effect.

• Results: The "Performance Data" section explicitly states: "The Pulmo-Mist compressor met all the required performance criteria and functioned as intended." It also notes: "Summary results for the legally marketed device show equivalent performance," reinforcing the substantial equivalence claim.

In summary, for K020797, the "study" was a series of engineering, electrical, mechanical, and safety tests conducted in accordance with recognized standards and FDA guidance documents to demonstrate that the physical device functions as intended and is substantially equivalent to a predicate device.

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The Silenzio Delta is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients 30 kg and over.

Silenzio Delta has three modes of operation. In CPAP mode,treatment is carried out by applying a continuous positive airway pressure through a nasal mask. In the BPAP mode, the pressure during expiration is lower than during inspiration, as prescribed by the physician. In a third mode, a minimum breathing rate can be set between 0 to 25 BrPM. The operation is identical as in BPAP mode, but if the patient fails to make an inspiratory effort within the interval set by the minimum BrPM control, the device will cycle to the pressure support level to deliver the breath to the patient based on the minimum BrPM setting.

The Silenzio Delta can be used to administer oxygen by using external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise regulated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Silenzio Delta Continuous Positive Airway Pressure System. It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed.

The letter primarily:

• Confirms the device has been reviewed and determined to be "substantially equivalent" to legally marketed predicate devices.
• Outlines general regulatory requirements for the device.
• Provides contact information for further regulatory inquiries.
• Includes the "Indications For Use" for the device, describing its intended purpose and modes of operation.

Therefore, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them based on the provided text. The requested information would typically be found in a more detailed technical submission or clinical study report, which is not part of this FDA letter.

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