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The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.

Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.

The FDA 510(k) clearance letter and supporting documentation for the Portable Oxygen Concentrator (Spirit-3) do not describe a study involving an AI/ML component or human readers. Therefore, there is no information available regarding acceptance criteria related to AI/ML performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The provided document focuses on demonstrating the substantial equivalence of the Spirit-3 Portable Oxygen Concentrator to predicate devices through technical specifications, non-clinical performance testing (bench testing), and compliance with various international standards. The "performance" being discussed in the document refers to the physical and functional performance of the oxygen concentrator itself (e.g., oxygen concentration, flow control, electrical safety, biocompatibility), not the performance of an AI/ML algorithm in an image or data interpretation task.

Therefore, many of the requested categories are "Not Applicable" (N/A) in the context of this specific regulatory submission.

However, I can extract the acceptance criteria and reported device performance for the Spirit-3 Portable Oxygen Concentrator based on the non-clinical tests described.

Here's the information derived from the provided text, adapted to the requested format where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the Spirit-3 Portable Oxygen Concentrator meets its acceptance criteria was a series of non-clinical bench tests and evaluations demonstrating compliance with recognized consensus standards and comparison to a legally marketed predicate device.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm being evaluated. For the performance testing of the physical device, it implicitly refers to the specific unit(s) of the Spirit-3 device undergoing testing. The document does not specify the number of devices tested but implies standard product testing.
• Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturing and submission process for Jiangsu Yuyue Medical Equipment & Supply Co., LTD. (China). This is prospective testing of the manufactured device.

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

• Not Applicable. This device is a physical oxygen concentrator, not an AI/ML diagnostic or interpretative device that requires expert ground truth for output validation.

4. Adjudication method for the test set:

• Not Applicable. As no expert interpretation was required. Device performance was objectively measured against predefined standard requirements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is relevant for AI/ML systems that assist human readers in tasks like image interpretation. The Spirit-3 is a portable oxygen concentrator and does not involve human reading or AI assistance in that capacity.

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

• Not Applicable. The device does not involve a standalone algorithm for diagnostic or interpretative purposes. "Standalone" performance in this context refers to the device's inherent mechanical, electrical, and oxygen delivery performance.

7. The type of ground truth used:

• The "ground truth" for the performance of the portable oxygen concentrator is defined by the international consensus standards mentioned (e.g., ISO 80601-2-69, ISO 80601-2-67, IEC 60601-1, ISO 10993 series) and the specifications of the predicate devices. These standards provide benchmarks and methodologies for evaluating physical and electrical safety, essential performance, and biocompatibility.

8. The sample size for the training set:

• Not Applicable. This device does not use an AI/ML training set.

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

• Not Applicable. No AI/ML training set was employed for this device.

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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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The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The SPIRIT™ Navigable Lead Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), to aid in positioning of the device in the vasculature.

The provided 510(k) summary for the Acumen Medical, Inc. SPIRIT™ Navigable Lead Delivery Catheter (K083855) does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or information on AI/ML components.

This document describes a medical device that introduces pacing or defibrillator leads and catheters. It is a traditional medical device submission, primarily focused on establishing substantial equivalence to a predicate device (Acumen Lead Delivery Sheath with Stylet, K070197) based on similar intended use, method of operation, construction, materials, and biocompatibility testing. Performance is generally asserted through "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." without detailing specific performance metrics or study designs.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's what can be inferred or stated based on the available information:

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not specified as no such test set or ground truth establishment is described for performance evaluation.

4. Adjudication method for the test set

• Not applicable/Not specified.

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 a traditional medical device (catheter) and does not involve AI/ML or human readers/interpretation in the way an imaging AI diagnostic device would.

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

• No. This is not an AI/ML algorithm.

7. The type of ground truth used

• Not applicable/Not specified, as performance testing details are very high-level. For a mechanical device like this, "ground truth" would typically refer to engineering specifications and performance capabilities (e.g., tensile strength, bending radius, flow rates) as tested in a lab setting, rather than clinical outcomes or expert labels.

8. The sample size for the training set

• Not applicable/Not specified, as this device does not involve an AI/ML algorithm that requires a training set.

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

• Not applicable/Not specified.

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The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). 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 vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 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 headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous 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 dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document is a 510(k) summary for the Caire Inc. Spirit 300 Portable Liquid Oxygen Unit. It describes the device, its indications for use, and confirms that modifications have not altered the fundamental scientific technology of the predicate device.

Based on the provided text, there is no acceptance criteria or study information that describes device performance in the way requested. This document is a regulatory submission summary for substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Here's why:

• Type of Document: This is a 510(k) summary, primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory approval. It asserts that modifications haven't altered fundamental technology, but it doesn't present the detailed test results or the specific acceptance criteria for those tests.
• Focus on Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technical characteristics and demonstrating that any differences don't raise new questions of safety or effectiveness. It's not typically about proving performance against a novel set of clinical acceptance criteria with detailed study results as one might find for a PMA or CE Mark submission.

The document states: "Caire Inc confirms that the modifications described here within have not altered the fundamental scientific technology of the predicate device (Spirit 300) cleared under 510(K) number K013251." This is the primary "proof" offered in this summary, not a new study.

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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 ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.

The ACCU-CHEK Spirit Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows the delivery of 0.1 to 25.0 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal or meal bolus.

The provided text does not contain specific acceptance criteria, study details, or performance metrics for the ACCU-CHEK Spirit Insulin Infusion Pump.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.

The only statement related to device performance is a general claims that "Testing of the ACCU-CHEK Spirit demonstrated that the device meets the resuirements for its intended use. The data also demonstrates that the ACCU-CHEK Spirit is substantially equivalent to the predicate devices." No specific criteria or reported performance values are given.

Therefore, I cannot provide the requested table and detailed information about the study as the necessary data is not present in the provided text.

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The SOMATOM Spirit is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (* spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Spirit is a whole body X-ray computed tomography stanners, The Siemens SOMATOM 'Spint is a 'Wiole' 600' whole '600' '1. tem' which features a continuously rotaing tube-detector system and functions according to the fan which features a coliminously folling tabe accords of program used for patient beam principle. The system soltware is a control, image reconstruction, and image archive/evaluation.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the SOMATOM Spirit, a Computed Tomography X-ray System, outlining its safety and effectiveness for substantial equivalence to predicate devices. It focuses on the device description, indications for use, technological characteristics, and general safety and effectiveness concerns related to regulatory standards, rather than performance metrics or a detailed study of its capabilities.

Therefore, I cannot provide the requested information.

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The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators.

SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment.

All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.

The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA).

The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem.

The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system.

The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function.

ResTrax™ ~ResTrax™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory.

The ResTrax™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population.

Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTrax™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.

The provided text describes a 510(k) submission for the S7™ Elite and AutoSet® Spirit™ CPAP Systems with the SomnoTraxx™ System. This submission is for a modification to an existing device, specifically adding an accessory (the SomnoTraxx™ System) for wireless data transmission.

However, the document is a regulatory filing that focuses on demonstrating "substantial equivalence" of the modified device to predicate devices, rather than a detailed report of a study designed to prove the device meets specific acceptance criteria in the manner one might find for a novel diagnostic or therapeutic algorithm.

Therefore, much of the requested information regarding detailed acceptance criteria tables, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly provided in this type of regulatory document.

Here's what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the SomnoTraxx™ system's data transmission or display functionalities, nor does it present detailed quantitative performance results against such criteria. The "acceptance criteria" here refer more broadly to demonstrating that the modified device (with SomnoTraxx™) still functions safely and effectively, and is "substantially equivalent" to predicate devices.

The key statement regarding performance is:
"Design Verification and Validation were performed on the S7 Elite™ & AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System, in accordance with the risk analysis and product requirements. All tests with ourned the product meets the acceptance criteria. ResMed has determined that the modified design has oonlined the product mode effectiveness of the device."

This indicates that internal tests were conducted, and the reported device performance is that it "meets the acceptance criteria" and maintains the "effectiveness of the device" (meaning the core CPAP function is not degraded by the addition of SomnoTraxx™ and the SomnoTraxx™ itself performs as intended). No specific numerical performance metrics are given.

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

• Sample Size for Test Set: Not specified. The document refers to "Design Verification and Validation" tests but does not detail the number of units, data points, or patients used in these tests.
• Data Provenance: Not specified explicitly as patient data. The tests would likely involve laboratory or simulated environments to verify the functionality of the wireless transmission and data retrieval. As the SomnoTraxx™ is an accessory for existing CPAP systems for home use in the US, the provenance of eventual usage data would be from US patients in a home setting, but the verification and validation data for the accessory itself are not detailed. These tests are likely retrospective, as they are performed on the designed system before marketing.

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

Not applicable/Not specified. This type of information is typically for diagnostic algorithms where a "ground truth" needs to be established (e.g., presence or absence of a disease). For a system focused on wireless data transmission of usage and therapeutic information, the "truth" is whether the transmitted data accurately reflects the data stored in the CPAP device. This would be verified through technical tests, comparing source data to received data, rather than through expert medical assessment of cases.

4. Adjudication Method

Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts who establish a ground truth. Since expert consensus on medical findings is not the nature of the "ground truth" for this device, an adjudication method is not relevant.

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

Not applicable. An MRMC study assesses how human readers' performance changes with or without AI assistance. The SomnoTraxx™ system is a data transmission and display system, not an AI-assisted diagnostic or interpretive tool that directly aids human readers in making a diagnosis or interpretation in the clinical sense. It augments follow-up care by providing data, but it does not replace or assist a human in interpreting diagnostic images or complex medical signals.

6. Standalone (Algorithm Only) Performance Study

The SomnoTraxx™ system's core function (wireless transmission and display of data) is inherently "standalone" in that it performs its function without human intervention in the data transmission process itself. However, it is an "augmentation" to human follow-up care. The testing would have focused on the accuracy and reliability of the data transmission and storage, which can be considered its standalone performance. No specific performance metrics like accuracy, reliability percentages, or latency are provided in this summary.

7. Type of Ground Truth Used

For the SomnoTraxx™ system, the "ground truth" would be the actual usage and therapeutic information stored within the S7 Elite or AutoSet Spirit CPAP flow generator's memory. The verification tests would have compared the wirelessly transmitted and displayed data against this source data to ensure fidelity.

8. Sample Size for the Training Set

Not applicable. The SomnoTraxx™ system's functionality (wireless data transmission) is based on engineering design and communication protocols, not on machine learning algorithms that require a "training set" to learn from data.

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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