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The Spirit Hair Removal laser Family intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy.

The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin.

The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm² for the 918 model and 4.5 to 10J/cm² for the 916 model) is preset.

For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair.

The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.

The provided text is a 510(k) premarket notification for the "Spirit Hair Removal Laser Family" (K153718). It focuses on demonstrating substantial equivalence to a predicate device (Soprano XL K112031) rather than presenting a study to prove a device meets specific acceptance criteria based on its own clinical performance for effectiveness.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted directly from this document. The document primarily describes the justification for substantial equivalence through comparison with a previously cleared device and adherence to safety standards.

Here's a breakdown of the information that can be extracted, and where requested information is not available:

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

The document does not explicitly state "acceptance criteria" for clinical performance that the device itself must meet (e.g., a specific percentage of hair reduction to be considered effective). Instead, it establishes substantial equivalence by comparing its technological characteristics and intended use to a predicate device.

The tables provided compare features of the Spirit Hair Removal Laser Family to the predicate device, demonstrating they are technologically similar and perform comparably, which serves as the basis for substantial equivalence rather than fulfilling novel performance criteria.

The acceptance criterion for this submission is "substantial equivalence" to the predicate device. The performance shown is that the Spirit Hair Removal Laser Family's characteristics and safety comply with relevant standards and are comparable to those of 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)

The document mentions "Bench and clinical data demonstrate that the Spirit Hair Removal laser Family meet the required specifications." However, no sample size or specific details about a clinical test set are provided. The focus is on demonstrating equivalence through technical specifications and safety standards, rather than direct new clinical efficacy data for this specific device. The clinical data referred to might be from the predicate device or a general understanding, but details are absent for the Spirit Hair Removal Laser Family.

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 document does not describe a study involving expert assessment to establish a "ground truth" for a test set.

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

Not applicable. No such study involving adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser for hair removal, not an AI-assisted diagnostic device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This refers to an algorithm's performance, which is not relevant for a physical laser device. The "performance" of the laser is its ability to meet documented technical specs and operate safely.

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

Not applicable, as no specific clinical efficacy study is detailed for this device where a ground truth would be established. The document relies on the "ground truth" that the predicate device is safe and effective for its indicated use, and the new device is substantially equivalent. The definition of "Permanent reduction in hair regrowth" as "the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime" could be considered an "outcomes data" ground truth for hair removal efficacy generally, but it's not a parameter measured in a new clinical study for this submission.

8. The sample size for the training set

Not applicable. This device is a physical laser system, not an algorithm that requires a training set.

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

Not applicable. This device is a physical laser system, not an algorithm that requires a training set.

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The Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment in a dental operatory.

The Spirit Dental Operative Units serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, foot control, and a junction box that houses a power supply and air/water regulators. Various Handpieces and accessories can be added to the Spirit Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them into the Sprit Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments.

The provided text is a 510(k) Summary for a dental operative unit, not a study describing AI device performance. Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This document focuses on establishing "substantial equivalence" to a predicate device for regulatory approval, primarily through non-clinical testing and comparison of technical specifications, rather than presenting a performance study of a device against specific acceptance criteria in the way you've described for an AI-powered medical device.

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Non-diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

Not Found

This document is a 510(k) premarket notification letter from the FDA for a dental operative unit and accessories (Trade/Device Name: Spirit/DocPortMacro). It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for AI/ML-based medical devices.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It pertains to a physical dental device, not software or an AI/ML product. Therefore, I cannot extract the requested information from the provided text.

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The Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life sustaining nor life supporting device.

The Spirit 300 HAS is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. Dependant on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent setting for 1, 1.5, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting. The Spirit 300 HAS is filled from a concentrator liquefaction device.

The provided text is a 510(k) summary for the Spirit 300 HAS Portable Liquid Oxygen Unit. It describes the device and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and validation study results in detail. While device performance in terms of flow settings is mentioned in the device description, specific acceptance criteria for these performances and the studies validating them are not provided in this summary.

Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based on the provided text.

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The Spirit 5000 Cardiac Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit 5000 Cardiac Coil is compatible with SENSE technology and designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Spirit 5000 Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is designed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc.

The indications for use are the same as for standard imaging:

The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time (1) spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Spirit 5000 Cardiac Coil is a four element receive only phased array coil. The coil is composed of rigid top and bottom pieces. A split top latch releases the coil from either side. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and have a high impact and tensile strength.

The provided document is a 510(k) premarket notification for the Spirit 5000 Cardiac Coil. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of a novel AI/software medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

Here's why and what information is available:

• Nature of the Device: The Spirit 5000 Cardiac Coil is a hardware component (a receive-only phased array RF coil) for an MRI system, not an AI/software device that generates diagnostic interpretations or measurements.
• 510(k) Process: For devices like this, the primary demonstration of safety and effectiveness is through comparison to legally marketed predicate devices, showing that the new device has "substantially equivalent" technological characteristics and intended use. This typically involves engineering tests, compatibility testing, and performance specifications, but not usually extensive clinical studies with expert-adjudicated ground truth and specific performance metrics like sensitivity/specificity in the context of diagnostic algorithms.

Information that can be extracted or inferred from the document:

• Acceptance Criteria and Reported Device Performance: This information is not provided in the format requested, as the submission focuses on equivalence. The "Safety and Effectiveness" section (page 1, section 9) details product features and compares them to predicate devices, indicating similarity rather than reporting distinct performance metrics against specific acceptance criteria. For example:

  • Intended Use: "imaging of the cardiovascular system" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
  • Indications for Use: "Identical to routine MRI imaging" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
  • Coil Enclosure Material: "Flame Retardant Polyurethane, Flame Retardant Polycarbonate" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
  • Coil Design: "Receive-only phased array coil" - "Similar to the Interventional Body Coil (K000437)"
  • Prevention of RF Burns: "Does not transmit RF Power, Decoupling isolates the coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing." - "Similar to the Interventional Body Coil (K000437)"
  • Radio Frequency Absorption: "Coil is a receive only coil and does not transmit RF power." - "Similar to the Interventional Body Coil (K000437)"

• Sample size for the test set and data provenance: Not applicable/Not provided. The document does not describe a "test set" in the context of evaluating diagnostic performance with patient data or a specific algorithm.

• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a requirement for this type of device and submission.

• Adjudication method for the test set: Not applicable/Not provided.

• MRMC comparative effectiveness study: No. This is a hardware component, not an AI system that assists human readers.

• Standalone (algorithm only without human-in-the loop performance) study: No. This is a hardware component.

• Type of ground truth used: Not applicable/Not provided. The "ground truth" for a cardiac coil would relate to its engineering specifications and imaging capabilities (e.g., signal-to-noise ratio, image uniformity), which are part of its technical characteristics, but not "ground truth" for diagnostic accuracy in the way it's used for AI.

• Sample size for the training set: Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.

• How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided document outlines the FDA's decision regarding a traditional medical device hardware component (MRI coil) based on substantial equivalence, and therefore does not contain the detailed performance and study information typically associated with the evaluation of AI/software medical devices.

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The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III Total SENSE Cardiac Coil is designed for use with the Intera 3.0T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.

Anatomic Regions: cardiovascular system Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Spirit III TotalSENSE Cardiac Coil is a six element receive only phased array coil. The coil is composed of a flexible top piece and a rigid bottom piece. The flexible top piece allows for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible and rigid plastic housings, which are fire rated. All rigid plastic housing parts have a high impact and tensile strength.

Here's an analysis of the provided text regarding the Spirit III TotalsENSE Cardiac Coil, structured to address your requested information.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation is primarily a 510(k) submission summary for a Magnetic Resonance Imaging Accessory. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Note: The acceptance criteria are largely implied by the comparison to predicate devices, where the "acceptance" is that the new device performs identically or similarly in these functional and safety aspects. This document does not provide quantitative performance metrics (e.g., signal-to-noise ratio, image resolution benchmarks) that would typically be associated with a detailed performance study. The safety aspects (RF burns, RF absorption) are critical for MR coils and are addressed by design features.

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

The provided text does not describe a specific clinical or technical test set with a defined sample size. The submission focuses on a comparison to predicate devices based on design features, intended use, and indications for use. There is no mention of a study involving real patient data or a specific "test set" that was evaluated. Therefore, no information on data provenance (country, retrospective/prospective) is available.

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

Since no specific test set or clinical study is described, there is no information provided regarding experts establishing ground truth. The assessment is primarily technical and regulatory, comparing the new device's specifications to existing, cleared devices.

4. Adjudication Method for the Test Set

As there is no described test set or clinical data evaluation, there is no adjudication method mentioned.

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

The document describes an MRI accessory (a cardiac coil), not an AI-powered device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant in this context. The study is not comparing human reader performance with or without AI assistance.

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

This device is an MRI coil, a hardware component. It is not an algorithm or software that would have a standalone performance evaluated. Therefore, no standalone performance study was done in the context of an algorithm.

7. The Type of Ground Truth Used

Given that this is a 510(k) for an MRI coil, the "ground truth" for demonstrating safety and effectiveness relies on engineering specifications, design comparisons to predicate devices, and adherence to established safety principles for MRI equipment. It does not involve medical ground truth like pathology, expert consensus on disease diagnosis, or outcomes data from a clinical trial in the way an AI diagnostic device would. The ground truth here is predominantly technical conformance and substantial equivalence.

8. The Sample Size for the Training Set

The device is a hardware component (an MRI coil), not a software algorithm that requires a training set. Therefore, there is no training set sample size.

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

As explained above, there is no training set for this device.

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The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.

The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Siemens Magnetom Trio 3.0T MRI scanner manufactured by Siemens Medical Solutions, Inc.

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Spirit III TotalSENSE Cardiac Coil is an eight element receive only phased array coil. The coil is composed of a flexible top piece and a rigid bottom piece. The flexible top piece allows for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible and rigid plastic housings, which are fire rated. All rigid plastic housing parts have a high impact and tensile strength.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria for the Spirit III TotalSENSE Cardiac Coil. The document is a 510(k) premarket notification summary and a letter from the FDA determining substantial equivalence to predicate devices, focusing on the device's intended use, description, and comparison to existing technology. It does not include specific performance metrics, study designs, or data about the device's performance against predefined acceptance criteria.

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The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients.

The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.

The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear.

The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube.

The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.

The provided text describes a medical device, the Spiritus™ Respiratory System, a patient interface accessory for positive airway pressure treatment. However, the document is a 510(k) summary and approval letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance studies with acceptance criteria in the manner typically seen for novel AI/ML devices.

Therefore, much of the requested information (like sample size for test/training set, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods) is not available in this document. The document describes traditional engineering performance testing, not studies of diagnostic accuracy that would involve expert readers or AI algorithms.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the way that would be expected for a diagnostic AI device. Instead, it lists the types of performance tests conducted and asserts that these tests confirmed the device's performance. The implied acceptance criterion for these tests is "meets performance expectations for a substantially equivalent device."

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

• Test Set Sample Size: Not specified. Standard engineering-style performance testing was performed, not studies on patient data.
• Data Provenance: Not applicable in the context of device performance testing described. These are likely bench or laboratory tests.

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

• Number of Experts: Not applicable. These were engineering performance tests, not human-read diagnostic studies.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. The device is a patient interface accessory, not a diagnostic imaging device or an AI algorithm that would typically undergo MRMC studies.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering standards, specifications, and comparison to the predicate device's known performance for flow resistance, enclosed volume, and intentional leak rate.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI/ML 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.

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The CAIRE Spirit 300 will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 is neither a life sustaining nor life supporting device.

The Spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuuminsulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. The economizer regulator riams the ony gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below 20 PSI, the economizer regulator will draw liquid oxygen from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar head regulator be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold. Dependant on the flow selection setting, the manifold either delivers the gas to the the manifolial Deportually diverts a 2 LPM continuos flow directly to the oxygen outlet. The continuos flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document describes a 510(k) premarket notification for the CAIRE Spirit 300, a portable liquid oxygen unit. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined.

The document primarily focuses on establishing substantial equivalence to predicate devices (CAIRE Stroller, Puritan Bennett HELiOS, DeVilbiss LP05PP) based on technological characteristics and non-clinical testing. It states that the Spirit 300 "oxygenates similarly" to the predicate devices.

Therefore, I cannot provide the requested information in the format because the data is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance: This information is typically found in performance testing reports, which are not included here. The document only generically states "non-clinical testing clearly shows that the Spirit 300 oxygenates similarly" to predicate devices. It notes slight differences, such as the Spirit 300 being "more sensitive" and oxygenating "a little better at the higher flow settings" than the DeVilbiss product.
• Sample Size (test set) and Data Provenance: Not specified. "Non-clinical testing" is mentioned, but no details on the number or type of tests, or the origin of any data, are provided.
• Number of Experts and Qualifications: Not specified. This typically relates to ground truth establishment for diagnostic or interpretive devices, which the Spirit 300 is not.
• Adjudication Method: Not applicable or specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. The Spirit 300 is an oxygen delivery device.
• Standalone (algorithm only) performance: Not applicable. This device is not an algorithm, but a physical medical device.
• Type of ground truth used: Not applicable in the context of diagnostic performance. For a device like this, performance would be measured against engineering specifications (e.g., oxygen flow rate, concentration, duration).
• Sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

• Description of the Device: The Spirit 300 is a small, lightweight liquid oxygen portable unit with a vacuum-insulated cryogenic dewar, vaporizer coil, economizer regulator, pressure safety relief valves, manifold, electronic printed circuit board conserving device, and protective case. It has a 0.3-liter liquid oxygen capacity.
• Intended Use: Provides supplemental oxygen for ambulatory home healthcare patients by vaporizing medical grade liquid oxygen and dispensing it via an integral electronic conserving device. It is not a life-sustaining or life-supporting device.
• Technological Characteristics vs. Predicate Devices:
  • CAIRE Stroller: Spirit 300 has an integral electronic conserving device (delivers doses with patient inhalation) vs. Stroller's continuous flow. Spirit 300 is smaller/lighter. Dewar design, plumbing, fill connectors, relief valves, and vent valves are similar. Non-clinical testing showed similar oxygenation.
  • Puritan-Bennett HELiOS: Spirit 300 has an integral electronic conserving device vs. HELiOS's pneumatic conserving device. Otherwise, similar. Non-clinical testing showed similar (or significantly better) oxygenation.
  • DeVilbiss #LP05PP: Similar technical operation of conserving devices. Spirit 300 is 0.34L capacity vs. DeVilbiss 0.49L. Non-clinical testing showed similar oxygenation, with Spirit 300 being more sensitive and oxygenating "a little better at the higher flow settings."

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