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Morpheus is a prescription, patient-matched, mandibular repositioning device that is intended to reduce snoring or to treat mild to moderate obstructive sleep apnea. The device is intended for use by adult patients in either the home or sleep laboratory environment

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The provided document is an FDA 510(k) clearance letter for the Morpheus device, an intraoral device for snoring and obstructive sleep apnea. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications necessary to answer your request.

Therefore, I cannot fulfill your request using only the provided text. To answer your questions, I would need a detailed study report or a 510(k) summary that includes this information.

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BIOGENNIX Morpheus-C is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

Morpheus-C is a moldable, resorbable osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a biocompatible organic binder to facilitate shaping and containment of the implant. The osteoSPAN granules in Morpheus-C are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate with a thin laver of calcium phosphate throughout its entire porosity. The organic binder in Morpheus-C is a combination of a biocompatible polymer and type I collagen fibers. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold. The collagen in Morpheus-C provides improved intraoperative handling.

The provided document is a 510(k) premarket notification for a medical device called Morpheus-C, a resorbable calcium salt bone void filler. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way one might for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance measures, and ground truth establishment cannot be found or inferred from this document.

This document describes a traditional medical device (a bone void filler) where performance is typically assessed through:

• Biocompatibility testing: As detailed in Section VII, "Biocompatibility evaluation of Morpheus-C was conducted in accordance with 'Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.'" This included tests for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, and implantation.
• In vivo testing: "In vivo testing of Morpheus-C was conducted using a critically sized defect model. Device performance was evaluated at multiple time points against the primary predicate and negative controls using histology, histomorphometry, x-ray, and micro-CT analyses."
• Bench testing: "Bench testing results for various physical and chemical characteristics of the primary predicate apply to the subject device since the addition of the type I collagen does not affect the granule chemistry, crystallinity, porosity, pore interconnectivity, or density."
• Sterilization validation and shelf-life aging studies.

These tests are designed to show the device is safe and effective for its intended use and performs similarly to legally marketed predicate devices, not to meet "acceptance criteria" in the sense of a machine learning model's performance on a dataset.

In summary, none of the specific information requested in points 1-9 is available in this 510(k) document because it pertains to a different type of device (a physical implant) and a different type of evidentiary standard (substantial equivalence) than what is typically asked for AI/ML devices.

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Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound utilize the ultrasound probes, cable and host software application used in Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a self contained portable, multiplemode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.

User-customized parameter settings for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a B-Mode ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, and calculate angles. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device Interson USB Ultrasound Probe System, K070907.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound interfaces with the Interson USB Ultrasound Probe System software to collect the ultrasound images, measurements, and calculations. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound allows for the entry of patient information and generates reports from the recorded ultrasound images, measurements, and calculations.

The provided text describes a 510(k) premarket notification for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound systems. It asserts their substantial equivalence to a predicate device, the Interson USB Ultrasound Probe System (K070907). The document focuses on demonstrating this equivalence rather than presenting an independent study with new acceptance criteria and performance data for the device. Therefore, a direct table of acceptance criteria and reported device performance with specific values cannot be compiled from the provided text as the application relies on the predicate's established performance.

However, based on the provided text, we can infer the basis for acceptance and the type of study conducted to demonstrate this.

Here’s a breakdown of the requested information, derived from the document's content:

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

The provided document does not list specific, quantitative acceptance criteria for the subject devices, nor does it present new performance data for them. Instead, the acceptance criterion is substantial equivalence to an existing predicate device (Interson USB Ultrasound Probe System, K070907). The reported device performance is implicitly considered to be equivalent to that of the predicate device based on similar technological characteristics and a subset of clinical applications.

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

No new test set or data provenance details are reported for the subject device. The submission relies on the existing clearance of the predicate device (Interson USB Ultrasound Probe System, K070907). The specific studies and data used for the predicate device's clearance are not detailed in this document.

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

Not applicable. No new test set or ground truth establishment process is described for the subject device. The substantial equivalence argument relies on the predicate device's prior clearance.

4. Adjudication method for the test set

Not applicable. No new test set or adjudication method 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 an ultrasound imaging system, not an AI-assisted diagnostic tool to improve human reader performance. No MRMC study was conducted or referenced for the subject device.

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

Not applicable. The device is a diagnostic ultrasound system intended for use by a human operator, not an autonomous algorithm. The document emphasizes that the device functions identically to the predicate in how it generates images.

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

The type of ground truth for verifying the performance of the predicate device (and therefore implicitly the subject device) for diagnostic ultrasound imaging would typically involve comparison to other established imaging modalities, clinical findings, or expert interpretation. However, the current document does not specify the ground truth used for the predicate's original clearance.

8. The sample size for the training set

Not applicable. This document describes an ultrasound imaging device, not an AI/machine learning system that requires a training set.

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 Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Chevne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician.

Morpheus Ox displays heart rate, saturation and photoplethysmograph signals, acquired from an oximeter device. Morpheus Ox may also display signals including: EtCO2, Respiratory impedance, Plethysmograph Derived Respiratory (PDR) calculated signal, Activity, ECG, EEG, P flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP.

The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB).

The Morpheus Ox System is designed to process the raw signal data acquired by an oximeter device in standard medical download format, analyze them, obtain the study's analysis results, generate summary reports, and display the signals' data and reports on a personal computer, using a standard Internet Explorer Browser.

Signals from the oximeter device include the following:

• o Saturation
• o Photoplethysmograph signal

Scoring analysis and display includes:

• O Cheyne-Stokes Respiration (CSR)
• 0 Apnea/Hypopnea Index (AHI)
• o Display of acquired signals such as EtCO2, Respiratory impedance, Photoplethysmograph Derived Respiratory (PDR) calculated signal, ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP, and Heart rate.

Here's an analysis of the acceptance criteria and study details for the Morpheus Ox Automated Sleep Study Scoring and Data Management System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity values) that the device must meet. Instead, the "Performance Testing" section broadly states that the study was conducted "to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device."

Therefore, I will present the reported device performance as described in the "Substantial Equivalence" section, where it highlights its capabilities in relation to predicate devices.

Study Details

The provided text describes a clinical study conducted for performance validation.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It only mentions "a clinical study was conducted."

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

   • Not specified in the provided text.

3. Adjudication Method for the Test Set:

   • Not specified in the provided text.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study is not explicitly mentioned. The study is described as validating the accuracy of the device "against both a gold-standard PSG and predicate device," implying a standalone or comparative study of the device, not an assessment of human readers with vs. without AI assistance.

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

   • Yes, a standalone performance assessment of the algorithm appears to have been conducted. The text states: "...a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device." This refers to evaluating the Morpheus Ox System (the algorithm/software) directly.

6. The Type of Ground Truth Used:

   • The primary ground truth used was "a gold-standard PSG" (Polysomnography). The text states: "...a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device." Polysomnography is generally considered the gold standard for diagnosing sleep disorders.

7. Sample Size for the Training Set:

   • Not specified in the provided text. The text mentions "The Morpheus Ox software program is based on the Noga software program with the changes required to support its intended use and indications for use from the analysis of a different set of signals." This might imply that some underlying training or development was based on data used for the Noga system, but no specific training set size for Morpheus Ox is given.

8. How the Ground Truth for the Training Set was Established:

   • Not specified in the provided text. Given that Morpheus Ox is based on the Noga system, the ground truth for the Noga system's training would likely have involved expert-scored PSG recordings, but this is not explicitly stated for Morpheus Ox's development.

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The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The AngioDynamics 6F Triple Lumen Morpheus® SMART PICC CT and Procedure Kits device description is as follows:
• 6 French outside diameter, reversed tapered shaft design
• Catheter usable length is 55 cm
• Shaft inner lumen is a triple lumen design
• Catheter shaft tubing is marked with depth indicators
• The catheter has one power injectable lumen
• The product labeling warns against power injection procedures through the two small lumens, which are clearly identified as non CT.
• Three extension legs to facilitate injection through each lumen of the catheter shaft.

The AngioDynamics, Inc. Morpheus® SMART PICC CT and Procedure Kit is a medical device. The provided text describes the device, its intended use, and the verification activities undertaken to demonstrate its safety and effectiveness, primarily through comparison to predicate devices.

Here's the detailed breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of devices (sample size) used for each individual test. Instead, acceptance criteria are generally expressed with statistical confidence levels (e.g., "95% confidence that 95% of the population meets specification" or "95% confidence that 80% of the population meets specification"), implying that a sufficient sample size was used to achieve these statistical guarantees.

The data provenance is not specified regarding country of origin or specific details of test conditions beyond the type of tests. The studies are described as "verification/validation activities completed on the proposed device," which are typically laboratory-based engineering and performance tests rather than clinical trials with patient data. Thus, the data would be prospective in the sense that the tests were specifically designed and executed for this device submission.

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

This type of information is not applicable to the studies described. The "ground truth" for these tests (e.g., a catheter's flow rate, tensile strength, or burst pressure) is determined by objective measurements and engineering standards, not by expert consensus or interpretation of clinical findings.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective measurements against defined acceptance criteria, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the engineering and performance characteristics of the device, primarily comparing it to predicate devices based on objective technical specifications. It's a physical medical device, not an AI or imaging diagnostic tool that would typically involve MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This is not applicable. The device is a physical medical catheter, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications and objective measurements of the device's physical and functional properties, and comparison to the performance of legally marketed predicate devices. This includes:

• Physical durability (tensile strength, burst pressure)
• Flow rates (CT injection, gravity flow, aspiration)
• Mechanical behavior (tip whipping, tip displacement, stylet/wire withdrawal force)
• Biocompatibility (tested per ISO 10993)

8. The Sample Size for the Training Set

This is not applicable. The studies described are performance and safety verification tests for a physical medical device, not a machine learning model that would require a training set.

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

This is not applicable, as there is no training set for a physical medical device.

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MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.

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The provided document is a 510(k) premarket notification letter from the FDA for a device named "Morpheus," which is a cartridge syringe intended for anesthetic applications in dentistry. This document does not describe any acceptance criteria or a study that proves the device meets specific performance criteria.

The information typically requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is related to the evaluation of AI/ML or diagnostic devices. The "Morpheus" device, as described, is a cartridge syringe, which is a mechanical device, not a diagnostic or AI-powered one. Therefore, the type of performance evaluation and acceptance criteria for such a device would focus on aspects like materials biocompatibility, sterility, dimensions, force required for delivery, leakage, and other physical/mechanical properties, rather than diagnostic accuracy metrics.

The FDA letter essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness. This determination is based on the information provided in the 510(k) submission, which would include testing results relevant to the device's function as a cartridge syringe, but these specific details are not present in the provided FDA letter.

Therefore, I cannot provide the requested information based on the given input. The document does not contain the study details, acceptance criteria, or performance metrics typically associated with the evaluation of AI or diagnostic devices.

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The Morpheus ™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

The Morpheus ™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

The Morpheus™ 1, Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

The Morpheus 100 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This document primarily focuses on the FDA 510(k) clearance for the Morpheus™ 1 Automated Sleep Study Scoring and Data Management System, establishing its substantial equivalence to a predicate device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study description based on the provided text. The document is an FDA letter and a declaration of indications for use, not a clinical study report.

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