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The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

The MOR System is a drug-free wearable patch system with single-use electrode patches, a reusable pulse generator, and a smartphone app. Together, these components deliver user-defined electrical stimulation to the perineal region.

The provided text is a 510(k) premarket notification document for a medical device called the "MOR System," a non-implanted electrical stimulation device intended to improve or enhance male sexual performance.

This document describes the device, its intended use, and its similarities to a predicate device (vPATCH). It details non-clinical testing performed, including electrical safety, EMC testing, software verification and validation (per IEC 62304), and biocompatibility testing (per ISO 10993-1).

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance metrics like sensitivity, specificity, or AUC, or comparative effectiveness studies with human readers.

The questions in the prompt refer to criteria and studies typically associated with the evaluation of AI/ML-driven medical devices, especially those involving image analysis or diagnostic aid, which require quantitative performance metrics and rigorous validation against expert ground truth.

Since the provided text does not contain the information required to answer the prompt's specific questions about acceptance criteria, performance studies, AI training/test sets, or ground truth establishment, I must state that this information is not available in the provided document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and non-clinical safety testing, rather than reporting on the performance of an AI/ML algorithm or its impact on human reader performance.

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The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.

The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.

The MOR 3.0mm Implant System consists of 3.0mm endosseous dental implants. The MOR 3.0mm implant is a one-piece endosseous dental implant, manufactured of Titanium 6AL-4V ELI. The portion of the implant that is submerged in the bone is a treated roughened surface (blasted and etched) to facilitate osseointegration. The MOR 3.0mm implant is similar in design to the MOR 2.4mm implant previously cleared by FDA. The implant lengths are10mm, 13mm, 15mm, and 18mm. The implant has two prosthetic head design options - 0-ball identical to Sterngold MOR 2.4mm Implant (K153173), and a Tapered Abutment similar to the IMTEC MDI MII One Piece Implant 2.9mm (K081653). This implant has the same design threads as the MOR 2.4mm Implant. The MOR Implants will be provided "Sterile" using Gamma sterilization.

The PUR 3.2mm Implant System consists of 3.2mm threaded endosseous dental implants, as well as prosthetic components. The prosthetic components include a Straight Narrow Platform Slim Abutment with a 1.5mm and 3.0mm cuffs and a 0.050' Hex Prosthetic Screw. The purpose of the Slim Abutments is to provide surgical and prosthetic options for smaller spaces. They attach directly to the implant with the aid of the prosthetic screw and provide the transitional link between the head of the implant and the restorative components. These abutments are straight and not intended for angulation. The PUR Straight Slim Abutments are similar to FDA cleared PUR Straight Abutments Narrow and Regular Platforms 1.5mm and 3.0mm cuffs (K151928). The difference is the body of the proposed Straight Narrow Platform Slim Abutment is more tapered. The abutments and prosthetic screw are made of Titanium 6AL-4V ELI. The ancillary component is a 3.2mm cover screw, which is flush with the top surface of the implant to prevent tissue and bone from growing inside the implant. It is screwed onto the immediately after implant placement. It is made of Titanium 6AL-4V ELI. The PUR 3.2mm implant is an endosseous dental implant made of Titanium 6AL-4V ELI with a treated roughened surface (blasted and etched). The implant body is tapered with double-lead threads and10 start micro threads at the collar. The implant lengths are 8mm, 10mm, 12mm and 14 mm. This implant The PUR 3.2mm implant features the same prosthetic platform as the 3.5mm and 4.3mm implants already cleared by FDA (K151928). The purpose of the 3.2mm PUR implant is to provide surgical and prosthetic options for smaller spaces. The PUR 3.2mm Implants will be provided "Sterile" using Gamma sterilization.

This looks like a 510(k) summary for dental implants, which are hardware devices and do not utilize AI. As such, the requested information (acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training data) is not applicable to this document.

The document describes non-clinical performance testing for mechanical properties (torque) and sterilization/biocompatibility, which are standard for medical devices. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of material, design, and intended use.

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MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. The MOR implants may also be used for interradicular transitional applications.

These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.

The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V - ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V - ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation.

The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.

The MOR Dental Implant will be available in a range of lengths and diameters.

Thread Major Diameter (mm): 2.1mm, 2.4mm
Overall Implant Length (mm): 10mm, 13mm, 15mm

Dimensional requirements for the finished abutment:
Angulation of final abutment: No angles
Minimum and Maximum Gingival Height: 1.0 - 3.0mm
Minimum abutment post height may be fabricated to: 4.0mm

This document is a 510(k) Premarket Notification for the MOR Implant System, a dental implant device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than providing detailed clinical study data or performance metrics for an AI/algorithm-based device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves an AI/algorithm-based device meets these criteria cannot be found in this document. This document describes the testing for a physical medical device (dental implants).

However, I can extract the information that is present and explain why other information is missing.

Summary of Information from the Provided Document Regarding Device Acceptance and Performance:

This document is a 510(k) Premarket Notification for a physical medical device (dental implants). The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to set new performance criteria or conduct extensive clinical trials that would be typical for novel AI/algorithm-based devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Performance testing demonstrated that the device performs appropriately for the proposed indications for use." ([Page 4] - under 'Performance Testing')
• "Based on our analysis, technological characteristics and performance testing, the MOR Implant System is substantially equivalent in intended use, material, design and performance to its predicates." ([Page 5] - under 'Conclusion')

However, it does not provide a table of quantitative acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity, which would be relevant for an AI device) nor does it report specific numerical performance results. The "performance testing" mentioned is non-clinical and likely refers to mechanical, material, and biocompatibility testing to show the physical implant functions as intended and is safe, rather than a clinical outcome or diagnostic performance metric.

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

• Not Applicable/Not Provided for Clinical Performance Data: This document does not describe a "test set" in the context of an AI model's performance on clinical data (e.g., patient images or records). The "performance testing" mentioned refers to non-clinical bench testing of the physical implant.
• Data Provenance: Not applicable for an AI test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: This process is for validating AI/algorithm performance. The document describes a physical dental implant, not an AI device.

4. Adjudication Method for the Test Set:

• Not Applicable: This is relevant for establishing ground truth in clinical data for AI validation.

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

• No: This study type is for evaluating human performance (e.g., radiologists) with and without AI assistance. This document describes a physical dental implant, not an AI system. Even if clinical data were mentioned, an MRMC study is not typically required for dental implant 510(k)s focused on substantial equivalence.

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

• Not Applicable: This is exclusively for AI/algorithm performance. The device is a physical dental implant.

7. The Type of Ground Truth Used:

• For the device (dental implant): The "ground truth" for a physical device like this is primarily established through engineering specifications, material science standards (e.g., ASTM F136 for titanium alloy), and non-clinical performance testing (e.g., fatigue testing, sterilization validation, biocompatibility) to ensure it meets mechanical strength, material safety, and functional requirements. It's not "expert consensus" or "pathology" in the diagnostic sense.
• The document explicitly references: "Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" ([Page 4])

8. The Sample Size for the Training Set:

• Not Applicable: This concept applies to the development of AI models. The document is about a physical dental implant, not an AI or algorithm.

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

• Not Applicable: As above, this pertains to AI model development.

In summary, the provided document is a 510(k) submission for a physical medical device (dental implants). It demonstrates "substantial equivalence" to previously cleared predicate devices based on design, materials, manufacturing processes, and non-clinical performance testing. It does not contain any information related to AI/algorithm performance, clinical study test sets, ground truth establishment by experts, or MRMC studies, as those concepts are not relevant to the type of device and regulatory submission described.

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The Monitoring Waveform Viewer is indicated for use as follows:

The Monitoring Waveform Viewer is a software component utilized within another software application.

The Monitoring Waveform Viewer performs the following:

• Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters.
• Display of reported alarm states produced by such monitoring systems.
• Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon.
• Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waver displays still waveforms.
• Provide selected waveform episodes to the host application for printing or inclusion in the patient record.

The Monitoring Waveform Viewer:

• Is not a primary or secondary alarm device.
• Does not provide a user interface for acknowledging or silencing active alarms.
• Does not generate audible or visual (flashing) notifications of active alarms.

The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

The Monitoring Waveform Viewer is a software component that includes a system for reviewing snapshots of monitoring data and offers a measurement module with user controlled calipers and magnifier glass.

Medical device data or information system applications may utilize the Monitoring Waveform Viewer software component that includes a stand-alone executable module that functions as a host application. The Monitoring Waveform Viewer is organized as a drawing surface with three areas:

• a parameters area located at the bottom of the window, .
• a parameter waveform area located at the right and
• . a main waveform area.

The parameters area is dedicated to report the values of parameters not associated with displayed waveforms. The parameter waveform area is dedicated to report the values of parameters associated to the displayed waveforms.

The application supports several numerical parameters such as: ECG (electrocardiogram), ART (arterial pressure), PA (pulmonary artery invasive blood pressure), ICP (intracranial pressure), IABP (intra-aotic balloon pump pressure), RR (respiration rate), EtCO2 (end tidal carbon dioxide), SpO2 (oxygen saturation), etc.

The Monitoring Waveform Viewer receives data parameters and waveforms supplied from multi-parameter patient monitoring systems. The Monitoring Waver is able to display alarm states by highlighting the corresponding parameter box. The Monitoring Waveform Viewer operating in near real time mode supports alarm priorities of High Priority, Medium Priority, and Low Priority.

The Monitoring Waveform Viewer allows the user to right-click over any ECG lead or the ECG parameter box to activate a context menu for selecting the ECG gain and displayed leads. The user is able to select a list of active (with data) ECG leads received from the host application. It also allows the user to select gains of 5, 10, 20 and 40mm/mV. The Monitoring Waveform Viewer provides a caliper tool for performance amplitude and interval measurements on the displayed traces. The caliper can be placed anywhere on the waveform display area.

The provided document is a 510(k) notification for the Mortara Monitoring Waveform Viewer, a software component. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense of diagnostic metrics (e.g., sensitivity, specificity).

However, based on the Performance Testing: Software Testing section, we can infer some aspects related to acceptance criteria and the "study" that proves the device meets those criteria.

Here's an attempt to extract the requested information, understanding that this is a software component and not a diagnostic device with traditional performance metrics:

Acceptance Criteria and Device Performance for Mortara Monitoring Waveform Viewer

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a software component for viewing and measuring waveforms, the "acceptance criteria" are related to its functional and performance specifications. Since specific quantitative thresholds are not provided in the document beyond a general statement of compliance, the table below represents the implicit criteria and reported performance.

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

• Sample Size: Not explicitly stated. The document mentions "test results." For software testing, the "sample size" would typically refer to the number of test cases executed. This information is not provided.
• Data Provenance: Not specified. The testing was conducted internally by Mortara Instrument, Inc. It's likely simulated or recorded patient data was used, but the origin (e.g., country, retrospective/prospective) is not detailed.

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

• Number of Experts: Not applicable or not specified. For functional software testing, "ground truth" often refers to the expected output of the software for given inputs, which is derived from the software's specified requirements. There is no mention of external human experts establishing ground truth for evaluating the software's performance on patient data, as this is a viewing and measurement tool, not a diagnostic one. The accuracy of measurements would likely be benchmarked against known values or manual measurements on the displayed data, rather than expert consensus on a clinical outcome.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since expert consensus on clinical diagnoses is not explicitly used to establish ground truth for this type of device, an adjudication method for conflicting expert opinions is not relevant or described. The "adjudication" in this context would likely be comparing software output to predetermined correct outputs based on specifications.

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

• MRMC Study: No. The document does not describe an MRMC study. The device is a "viewer" and "measurement tool," not a diagnostic AI intended to assist human readers in interpretation that would typically warrant an MRMC study. The focus is on the software component's ability to accurately display and measure, not on improving human diagnostic accuracy.

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

• Standalone Performance: Yes, in essence. The "Software Testing" and "Performance Testing – Bench" sections describe the device's performance as software. This testing evaluates the algorithm (software component) independently against its predetermined specifications for display, measurement, and functionality. There is no human-in-the-loop performance described beyond the general statement that "The data and analysis provided by the Monitoring Waveform Viewer is reviewed, confirmed, and used by trained medical personnel." The performance tests themselves assess the software's outputs directly.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this software component would be based on its functional specifications and expected outputs. For display features, it would be whether the waveforms and parameters are displayed correctly and accurately represent the input data. For the caliper tool, ground truth would be the known accurate measurements of simulated or recorded waveforms. This is essentially "specification-based verification" or "expected output" rather than clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a software component for viewing and measurement; it does not appear to employ machine learning or AI that would require a "training set" in the conventional sense. The software is developed based on deterministic algorithms and rules.

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

• How Ground Truth was Established: Not applicable, as there is no "training set" for this type of software component. Its functionality is based on direct programming logic and specifications rather than learning from data.

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The MORCELLEX SIGMA™ Generator is used with the following ETHICON Morcellation Devices: GYNECARE X-TRACT™, GYNECARE MORCELLEX™, and MORCELLEX SIGMA™. The MORCELLEX SIGMA™ Generator is used in conjunction with the ETHICON Morcellation Devices for gynecologic, urologic, and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers. The MORCELLEX SIGMA™ Generator is used in conjunction with ETHICON Morcellation Devices for cutting, coring, and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

The MORCELLEX SIGMA™ Generator provides mechanical power to the ETHICON laparoscopic tissue morcellators via the morcellator's Flexible Drive Cable which connects the morcellator to the MORCELLEX SIGMA™ Generator. The MORCELLEX SIGMA™ Generator is equipped with a bi-directional motor that has a user-selectable speed range at which to rotate the ETHICON laparoscopic tissue morcellator. Activation buttons located on the Front Panel of the device allow the user to select the motor rotation direction and the speed of rotation.

The provided text describes the MORCELLEX SIGMA™ Generator, a device used with laparoscopic tissue morcellators, and its 510(k) pre-market notification. The document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study results for novel acceptance criteria.

The acceptance criteria and study information is highly limited to bench testing for performance and electrical safety/EMC.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it describes characteristics that were evaluated and implies that the performance met the requirements for substantial equivalence to the predicate device.

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

The document describes "bench studies" for performance evaluation and "Electrical safety and electromagnetic compatibility testing." There is no mention of a "test set" in the context of patient data or clinical imaging. These are laboratory-based tests. Therefore, specific sample sizes (e.g., number of devices tested for each characteristic) or data provenance (country of origin, retrospective/prospective) for a clinical test set are not applicable here.

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

Not applicable. This device is a mechanical generator, and the "ground truth" for its performance is established through engineering and electrical testing against design specifications and relevant standards, not through expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable, as there is no human-interpreted "test set" or clinical data 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

Not applicable. This device is a surgical generator and does not involve AI or human "readers" interpreting output.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical and electrical operation.

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

The "ground truth" for the device's performance is based on:

• Engineering specifications and design requirements: for characteristics like speed, torque, weight, and dimensions.
• International standards: IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility.
• Comparison to the predicate device: to establish substantial equivalence in terms of fundamental technology, basic design, principle of operation, and functional characteristics.

8. The sample size for the training set

Not applicable. This is a medical device (generator), not an AI algorithm 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 device.

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The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of: Non-invasive blood pressure, Impedance respiration, Invasive blood pressure, Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia & ST-segment, 12-Lead resting ECG, Cardiac output. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Mortara Instrument, Inc. Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Models within the Mortara Surveyor family come in two different sized viewing areas (11.6" and 18.5") and offer selected monitoring features.

The provided text describes the Mortara Surveyor Patient Monitor (S12 and S19) and aspects of its performance testing for its 510(k) submission. However, it does not include detailed acceptance criteria or the specific study data that would allow for a table of acceptance criteria versus reported device performance. It mainly states that the device "complies with its predetermined specification" and is "substantially equivalent to the predicate device" based on various tests.

Based on the provided document, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table cannot be constructed from the provided text. The document repeatedly states that test results indicated the device "complies with its predetermined specification" for various categories (Software, Electrical Safety, EMC, Bench Performance). It does not, however, spell out what those predetermined specifications (acceptance criteria) were, nor does it provide quantitative performance data to report against those criteria.

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

The document does not specify any sample sizes for test sets. It mentions "Software Testing," "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Performance Testing - Bench" but does not detail the number of cases or samples used in these tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned, as no clinical study data is presented.

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

This information is not provided. No clinical study was performed, and therefore, no experts were needed to establish ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set requiring expert ground truth was performed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor." This implies the device doesn't involve human interpretation that would be enhanced by AI, making an MRMC study irrelevant in this context.

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

While the device itself is an "algorithm only" in the sense that it's a physiological monitor, the document does not describe a standalone algorithm performance study in the way this question typically implies (e.g., for AI/ML devices). Instead, it refers to "Software Testing" and "Performance Testing - Bench" which validated the device's adherence to its predetermined specifications. No specific performance metrics or studies analogous to those for AI algorithms are detailed.

7. The Type of Ground Truth Used

For the specific testing mentioned (Software, Electrical Safety, EMC, Bench Performance), the ground truth would inherently be based on the device's predetermined specifications and engineering standards. For example, for electrical safety, the "ground truth" is compliance with applicable electrical safety standards. For software, the "ground truth" is that the software performs according to its design requirements. This is not "expert consensus," "pathology," or "outcomes data" as typically thought of in diagnostic imaging or clinical decision support.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this device's submission description. The described device is a physiological monitor, not an AI/ML-driven device that typically undergoes a "training" phase with data.

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

Not applicable, as no training set is mentioned.

Summary of what is present:

• Device Description: The Mortara Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitor for ECG, Respiration, NIBP, Temperature, SpO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG, and cardiac output.
• Intended Use: For knowledgeable healthcare professionals in a healthcare facility for continuous monitoring in stationary or portable applications, indicated for adult & pediatric patient populations.
• Performance Testing Categories (general statements of compliance):
  • Software Testing
  • Electrical Safety
  • Electromagnetic Compatibility Testing (EMC)
  • Performance Testing - Bench (functional, environmental, vibration/shock)
• Missing from the document:
  • Specific quantitative acceptance criteria.
  • Specific quantitative reported device performance data.
  • Sample sizes for any tests.
  • Data provenance.
  • Details on ground truth establishment if clinical data were used (which they weren't for performance).
  • MRMC or standalone algorithm studies (as the device is not presented as an AI/ML diagnostic system).

This document mainly focuses on engineering and regulatory compliance as opposed to detailed clinical performance metrics typically found in submissions for AI/ML diagnostic aids.

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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.

Not Found

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 Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gyrocological procedures to morcellate and remove tissue.

The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.

The Morce Power Plus / VarioCarve is the drive control unit for the morcellator. With a cutting blade on the distal end, a rotating cylindrical tube is inserted in the abdominal cavity.

This document is a 510(k) summary for the NOUVAG AG Morcellator (Morce Power Plus / VarioCarve). The device is a surgical morcellator used in laparoscopic procedures.

Here's an analysis of the provided text in relation to acceptance criteria and device performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics explicitly stated for the NOUVAG AG Morcellator. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against predefined criteria.

The general statement regarding performance is:

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

The document does not describe any specific test set or clinical study with a defined sample size. The substantial equivalence claim is made based on the device's technological characteristics being similar to already legally marketed devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as there is no described test set requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on comparative effectiveness with or without AI assistance (which is not relevant to this type of device).

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

No, a standalone (algorithm-only) performance study was not conducted or reported. This device is a mechanical surgical instrument, not an AI or diagnostic algorithm, so this type of study is not relevant.

7. The Type of Ground Truth Used

This information is not applicable as there is no described test set requiring ground truth. The basis for clearance is substantial equivalence to predicate devices, implying that the established safety and effectiveness of the predicates serve as a "ground truth" for the new device's similar characteristics and intended use.

8. The Sample Size for the Training Set

There is no mention of a training set in this 510(k) summary. This type of device (surgical instrument) does not typically involve AI models that require training sets.

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

This information is not applicable as there is no training set.

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