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The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediativ and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K170168. and has the same indications for use. The Rad-97 comprises the same measurement technologies as cleared in the predicate, which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The Rad-9, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 was also cleared in K170168. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, Pi, and PVi. The Rad-9 model can be optionally available with NIBP technology.

Masimo's Rad-97 has improved SpO2 measurement accuracy for motion and no motion conditions with RD SET Disposable sensors previously cleared under K170168. Masimo improved its RD SET Disposable sensors through sensor characterization, facilitating a SpO2 measurement accuracy claim of 1.5% Ams during no-motions conditions for patient populations (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Masimo's SpO2 measurement accuracy claim with RD SET Disposable Sensors is 1.5% Arms during motion conditions for patient population (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Although they now include improved sensor characterization, the RD SET Disposable sensors are substantially equivalent to the currently marketed product.

Additionally, this submission includes the following sensors that have non-significant changes: the Multisite Reusable Sensors (K111888), the RD Specialty Sensors (K101896), and the RD reusable sensors (K051212).

Here is a summary of the acceptance criteria and study information for the Masimo Rad-97 and Accessories, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Accuracy (ARMS)" specifications in the document.

Note: The clinical study specifically focused on SpO2 accuracy claims for no-motion and motion conditions for adult, pediatric, and infant populations. The document states that "Accordingly, the claimed Ams value is 1.5% during no-motion conditions for adults, pediatrics, and infants, and the claimed Arms value is 1.5% during motion conditions for adult, pediatrics, and infants." This implies that the reported study results support these specific claims, which are the acceptance criteria.

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

The document states: "The study was done on healthy adult volunteers".

• Sample Size: Not explicitly stated as a number, but refers to "healthy adult volunteers."
• Data Provenance: Clinical study, likely prospective, conducted on "healthy adult volunteers" at an unspecified location (typically assumed to be U.S. unless otherwise specified in FDA submissions).

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

Not applicable for this type of device and study. The ground truth for SpO2 accuracy is typically established by comparing the device's readings to arterial blood samples analyzed by a laboratory CO-Oximeter (as stated in the document: "in comparison to blood measurements from a laboratory CO-Oximeter"). No human expert "adjudication" of the ground truth is mentioned or implied for SpO2 measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 is directly derived from laboratory CO-Oximeter analysis of blood samples, not from expert adjudication of images or signals that would require an adjudication method like 2+1 or 3+1.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical accuracy study comparing the device's measurements directly to a reference standard (laboratory CO-Oximeter). It does not involve human readers or assess their improvement with AI assistance.

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

Yes, the clinical study performed was a standalone performance evaluation of the device (algorithm only) comparing its SpO2 measurements against a reference standard. The "human-in-the-loop" aspect for a device like a pulse oximeter is generally the medical professional interpreting the device's output, but the accuracy study assesses the device's measured values directly.

7. The Type of Ground Truth Used

Laboratory Standards: The ground truth for SpO2 measurements was established by "blood measurements from a laboratory CO-Oximeter."

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the validation study (test set).

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

The document does not provide information on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary for device modifications unless the model itself is novel and the training process is a key part of the submission. The device (Masimo Rad-97) and its underlying Rainbow SET technology are described as substantially similar to a cleared predicate (K170168), even with improved sensor characterization.

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The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.

The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.

This De Novo request is for an expanded indication (new intended use) for use with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.

The device is an automated temporary oral appliance that manipulates the mandible through multiple protrusion levels during an overnight sleep study in the home. The device uses the same interface as the MATRx plus Home Sleep Apnea Test, also from Zephyr Sleep Technologies, cleared under product code MNR, regulation 21 CFR 868.2375, cleared in K163665. These components include the recorder, tablet, oximeter, effector belt, and nasal cannula. The MATRx plus device for a titration study includes a mandibular positioner to determine an optimal titration position based on inputs of airflow and an oxygen desaturation index (ODI) of less than 10 events per hour. The device analyses the collected information and generates a report to assist the Healthcare Provider in the clinical management of oral appliance therapy for patients with mild to moderate obstructive sleep apnea. From this report, patients may be informed on the future efficaciousness of oral appliance (OA) therapy.

Specifically, the clinical management may be assisted by this type of oral appliance assessment study by prospectively identifying patients that are expected to achieve therapeutic success with oral appliance therapy. The oral appliance assessment study also includes the provision of a recommended target protrusive setting for the mandible through use of a legally marketed intraoral appliance (regulated under 21 CFR 872.5570, product code LQZ). The target protrusive setting is the amount of mandibular protrusion where the patient is expected to achieve efficacious therapy with the intraoral appliance and is used by the HCP to more effectively complete the titration process.

The use of the MATRx plus device for an oral appliance assessment study does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy as recommended by clinical practice guidelines.

The MATRx plus test identifies patients as suitable for intraoral therapy if a mandible protrusion level can be found where the patient has an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion.

Here's a structured breakdown of the acceptance criteria and the study that proves the MATRx plus device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Endpoints

Bench Performance Testing

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

• Sample Size for Test Set:
  • Clinical Study: The document provides "49" for "Successful Identification of Responders" and "2" for "Failure to Identify Responders" in the "Predictive Success Category," and "3" for "Successful Identification of Responders" and "6" for "Failure to Identify Responders" in the "Predictive Failure Category." This totals 49 + 2 + 3 + 6 = 60 participants in the mild to moderate OSA population for the effectiveness endpoints.
  • Human Factors: 15 patients were recruited for each study.
• Data Provenance: The MATRx plus is by Zephyr Sleep Technology, located in Calgary, Alberta, Canada. The clinical study was conducted in a clinical setting (dental professional's office for deployment, home environment for use). The study is prospective, as it involved recruiting participants, conducting the MATRx plus study, and then following up with custom oral appliance therapy.

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

• Number of Experts:
  • Effectiveness Ground Truth (Oral Appliance Outcome): While not explicitly stated how many individual experts reviewed each case, the process involved a "Sleep Health professional" reviewing baseline HSAT data and a "licensed dentist" conducting intraoral exams and subjective interviews post-study. The final determination of "successful treatment with an oral appliance" (ODI

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The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Pure Flow External Counter-Pulsa-tion device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.

The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.

PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.

The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896

This document, a 510(k) Summary for the Pure Flow External Counter-Pulsation Device (K173483), describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets acceptance criteria for a new clinical application or algorithm performance. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text in relation to your request:

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 (Test Set): For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, "Three models were tested."
• Data Provenance: Not specified, but the tests are non-clinical, likely internal laboratory testing. Country of origin not mentioned. The tests are prospective in the sense that they were designed to evaluate the physical device's performance.

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 describes non-clinical performance testing of a physical device, not an AI/algorithm-based diagnostic or prognostic tool that would require expert-established ground truth. The "ground truth" for these tests refers to the expected physical performance of the device as measured by calibrated equipment against established engineering standards.

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

• Not applicable. See point 3.

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 relates to an external counter-pulsation device, not an AI diagnostic/imaging system. No human reader studies are mentioned.

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

• Not applicable. This is a hardware medical device with some software control, not a standalone algorithm. Software verification and validation were done, but this refers to the robust operation of the device's control software, not a standalone algorithmic output.

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

• Non-clinical-specific ground truth: For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, the "ground truth" was established by reference standards (JIS T0601-2-204), which define acceptable ranges for device performance. These are engineering standards, not medical ground truths like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This document describes the testing of a physical device, and therefore does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable. See point 8.

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