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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 Morph DNA Steerable Introducer Sheath is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

The Morph DNA Steerable Introducer Sheath is sterile, single-use bidirectional deflectable catheter with an ergonomic handle that has an integrated swiveling hemostasis valve. When the handle is fully actuated, the distal tip deflects to a nominal angle in either of two directions based on the diameter and the working length of the catheter. The catheter tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock. Devices are packaged with a compatible dilator on a plastic backing card within a sealed Tyvek pouch, all of which are contained in a product box.

The provided text describes the 510(k) premarket notification for the BioCardia Morph DNA Steerable Introducer Sheath (K242169). This document does not include information about acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as the product is a physical medical instrument (a steerable introducer sheath), not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a machine learning model, as this content is not present in the provided document.

The document details the device's technical specifications, comparison to predicate devices, and various benchtop and simulated use tests conducted to demonstrate that modifications did not affect product specification requirements. These tests are focused on the physical and functional performance of the catheter, not on an AI's diagnostic or predictive capabilities.

Here's a breakdown of what the document does provide in relation to performance testing, which is different from an AI/ML performance study:

Device Performance Testing (Not AI/ML Study)

The document lists performance tests conducted to confirm the device meets product specifications due to modifications from predicate/reference devices.

1. Acceptance Criteria and Reported Device Performance: This section is presented as a list of tests conducted, implying that successful completion of these tests (meeting internal product specifications for each test) is the "acceptance criteria" for this type of physical device. The specific quantitative acceptance criteria values or detailed reported performance values for each test are not explicitly stated in the provided text. Instead, it indicates that the tests were conducted "to confirm that the modifications... did not affect the ability to meet all product specification requirements."

2. Sample Size Used for the Test Set and Data Provenance: Not applicable for a physical device. Testing would involve a number of manufactured units, but this is not typically referred to as a "test set" in the context of data for AI. No information on data provenance (country, retrospective/prospective) is provided as there's no data being collected for an AI model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The "ground truth" for a physical device like this is its physical and functional performance according to engineering specifications and simulated use scenarios, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set: Not applicable for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study is relevant for AI/ML diagnostic or prognostic tools that assist human readers. This is a physical medical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.

7. The Type of Ground Truth Used: For this physical device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993, ASTM standards) and internal product specifications for attributes like tip deflection, catheter diameter, material properties, and functional performance in simulated use models.

8. The Sample Size for the Training Set: Not applicable, as there is no training set for an AI model.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

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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

Not Found

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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More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.

When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.

The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:

• A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).

• B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Impermeability Testing: 36 More-Cell bags (retrospective, samples exposed to 2-years aging and simulated use).
• Mechanical Performance (various tests): 30 samples each (retrospective, samples exposed to 2-years simulated aging, with the exception of rivet testing).
• Animal Performance Testing: 16 animals (8 in test group with More-Cell-System, 8 in control group without). Type of data (retrospective/prospective) is not explicitly stated, but implies prospective due to it being an "in vivo porcine model" with randomized distribution. Country of origin not specified, but usually animal studies are controlled within a specific research facility.
• Clinical Usability Study (outside US): 26 clinical cases involving 26 surgeons. Data provenance: Austria (n=6), Germany (n=19), Switzerland (n=1). This is a prospective observational study.
• Simulated Use Study (US): 11 U.S. surgeons. Data provenance: US. This is a prospective simulated use study.

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

• Impermeability Testing: Not applicable. Ground truth was established by laboratory methods (immersion test with E. coli, positive and negative controls).
• Mechanical Performance: Not applicable. Ground truth was established by engineering specifications and objective measurements (e.g., force, pressure).
• Animal Performance Testing: "Two surgeons" performed the laparoscopic supracervical hysterectomy. Their qualifications are not specified beyond being "surgeons." Ground truth for the presence of disseminated myometrial cells was established by "positive cytology."
• Clinical Usability Study (outside US): 26 surgeons, with "various levels of experience." The "ground truth" here was subjective evaluation by the surgeons themselves (ease of insertion, visualization, etc.), and objective observation by study personnel for leaks and successful completion of procedures.
• Simulated Use Study (US): 11 U.S. surgeons "with a range of laparoscopic surgery experience (2.5 years to 30 years)." Similar to the other usability study, "ground truth" was adherence to critical tasks observed by study personnel, and subjective feedback from participants.

4. Adjudication Method for the Test Set

• Impermeability/Mechanical Testing: No specific human adjudication method mentioned, as these were objective lab tests comparing results against pre-defined acceptance criteria.
• Animal Performance Testing: "Positive cytology" determined disseminated cells. It's not specified if multiple pathologists or a single expert adjudicated the cytology results.
• Clinical Usability Study (outside US) & Simulated Use Study (US): The text mentions that surgeons were "asked to evaluate and record" and participants were "observed to assess adherence to critical tasks." This implies observation by study personnel. There is no explicit mention of an adjudication panel (e.g., 2+1 or 3+1) for discordant observations or evaluations; it appears to be direct observation and feedback.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not performed. This device is a physical medical device (containment system), not an AI/software product, so this type of study would not be relevant.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. As mentioned, this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Sterilization: Laboratory testing results (sterility assurance level).
• Shelf Life: Laboratory testing results (visual inspection, dye penetration, peel strength, microbiological stability) and functional testing.
• Biocompatibility: Laboratory testing results (cytotoxicity, sensitization, irritation, acute systemic toxicity).
• Impermeability: Laboratory testing results (E. coli immersion test) and cytology in animal model.
• Mechanical Testing: Engineering specifications and objective measurements (e.g., force, pressure via bench testing).
• Animal Performance: Pathological analysis ("positive cytology") for disseminated cells, and visual examination for bag breach.
• Usability Studies: Observational data on task completion, user feedback, and objective checks for leaks/damage.

8. Sample Size for the Training Set

No "training set" in the context of an AI/ML algorithm is mentioned or applicable here. The device is hardware. The studies described are for validation of the final device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical device.

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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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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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The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the following paramaters:

• 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 indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:

• Non-invasive blood pressure ●
• Impedance respiration
• . Invasive blood pressure
• Temperature
• Functional arterial oxygen saturation (SpO2) ●
• End-tidal & inspired CO2 ●
• ECG monitoring with arrhythmia ●
• 12-Lead resting ECG .

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 Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations.

Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5"display and comes with an optional 2 channel printer.

The Surveyor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, non-invasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO₂), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output.

The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Surveyor Network, the Surveyor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text only explicitly mentions a clinical study for the neonatal non-invasive blood pressure (NIBP) readings.

• Neonatal NIBP Clinical Study Test Set:
  • Sample Size: Not specified in the provided text.
  • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study was conducted to demonstrate safety and effectiveness for the neonatal patient population, implying prospective data collection specifically for this purpose.

For other parameters (e.g., ECG, SpO2), no specific test set sample sizes or data provenance are detailed. The substantial equivalence relies on compliance with various international standards, which typically involve testing against predefined datasets or clinical scenarios.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided in the given text for any aspect of the device's evaluation. The clinical study for neonatal NIBP refers to the demonstration of safety and effectiveness, but it does not detail the method for establishing ground truth or the involvement of experts in that process.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least, not mentioned) for the Mortara Surveyor S12 and S19 Patient Monitor based on the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with standards, and a single clinical study for one specific parameter (neonatal NIBP).

6. Standalone Performance Study

Yes, a standalone performance study was done for the neonatal Non-Invasive Blood Pressure (NIBP) readings. A clinical study was conducted to demonstrate the safety and effectiveness of these readings. The wording suggests that the device's performance for this specific function was evaluated independently.

For other parameters (like ECG, SpO2, etc.), the document primarily references compliance with various IEC and ISO standards (e.g., IEC 60601 series), which typically involve standalone testing of the algorithm or device's performance against defined benchmarks or simulated signals. The results of these tests, however, are not explicitly provided in the summary.

7. Type of Ground Truth Used

For the neonatal NIBP clinical study, the type of ground truth used is not explicitly stated. However, clinical studies designed to demonstrate safety and effectiveness, as mandated by ISO 81060-2:2013 (which specifies clinical investigation of automated measurement type sphygmomanometers), typically rely on:

• Simultaneously obtained reference measurements: Often from an "expert" or gold-standard measurement method (e.g., invasive arterial blood pressure monitoring for NIBP), or highly accurate manual measurements by trained observers using auscultation. The standard sets strict requirements for how these reference measurements are taken and compared.

For other parameters, the ground truth would be established by the respective standards they comply with (e.g., standardized ECG waveforms for arrhythmia detection, calibrated SpO2 simulators, etc.).

8. Sample Size for the Training Set

This information is not provided in the text. The document describes a clinical study for neonatal NIBP for validation/testing, not for training. Given the device's nature as a physiological monitor relying on established algorithms and hardware, it's less likely to involve a "training set" in the machine learning sense for its core functionalities, but rather calibration and verification against known signals or reference measurements during development.

9. How Ground Truth for the Training Set Was Established

As no training set is described or implied in the provided text, information on how its ground truth was established is not applicable/not provided.

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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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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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