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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Same technological characteristics (materials, measurements, principle of operation, transducer probe design, acoustic output limits).
• Same intended use (Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications).
• Similar safety and effectiveness features. | Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound:
• Materials: TPX brand Polymethyle Pentene (PMP) for lens; Ertalyte brand Polyetheylene Terephthalate (PET-P), Delrin for housing. (Identical to predicate)
• Measurements: Distance (mm), Circumference (mm), Area (mm²), Angle (degree). (Identical to predicate)
• Principle of Operation: Apply high voltage bursts to Piezoelectric material in the transducer and detect the reflected echo to construct 2D images for diagnostic purposes. (Identical to predicate)
• Transducer Probe Design: Mechanical sector ultrasound imaging probe that connects directly to host computer via USB. Host computer forms real-time ultrasonic images without additional electronics. (Identical to predicate)
• Acoustic Output Limits: SPTA.3 94 mW/cm² (Max), MI 1.9 (Max). (Identical to predicate)
• Clinical Applications: Subset of predicate's applications (Abdomen, OB/GYN, Urology). (Considered safe and effective as they are within the predicate's cleared range).
• Report:
  • Morpheus®/Pathway®: Multiple page report displaying up to 10 user selectable images, user notes, printed on standard 8 1/2" X 11" paper. (Enhanced functionality compared to predicate, but the underlying images and data are the same).
  • QuickScan®: Single page report displaying a single image, printed on 80mm thermal printer paper. (Condensed report compared to predicate, but underlying data is the same). |

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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