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The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coaqulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 90 Applicator is limited to Skin Types I-IV.

The InMode System with the Morpheus8 90 Applicator is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Fractora3D 90 Applicator (K180189), inclusive of minor software modifications. The InMode System with the Morpheus8 90 Applicator employs fractional RF multi-electrode technology for procedures requiring electrocoaqulation and hemostasis. The Morpheus8 90 Applicator is deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 90 Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 90 Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus a handle and a detachable, sterilized, disposable, singleuse 24 pin tip head accessory.

The provided text is a 510(k) summary for the InMode System with the Morpheus8 90 Applicator. It describes a device that is substantially equivalent to a previously cleared device. Therefore, the information provided focuses on demonstrating this substantial equivalence rather than presenting an independent acceptance criteria study for a novel device or AI algorithm.

Here's a breakdown based on your request, filling in where possible from the provided text and noting when the information is not available due to the nature of a 510(k) submission for an already cleared device's modification:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification (clearing the Fractora 3D 90 for a treatment depth of up to 7mm via software change) and claiming substantial equivalence to predicate devices, explicit "acceptance criteria" and "reported device performance" in the sense of a new clinical study with specific metrics are not detailed for the subject device in the provided document. Instead, the document relies on previously established performance of predicate devices and comparative testing.

The "acceptance criteria" can be inferred as meeting the safety and performance characteristics of the predicate devices. The "reported device performance" is implicitly that the subject device performs equivalently.

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for patients or clinical cases. The testing was primarily ex-vivo tissue testing and bench testing.
• Data Provenance: The testing for the current submission was conducted to compare the subject device to the predicate devices. The original predicate device (K180189) performance testing is referenced, and further ex-vivo testing was performed with the secondary predicate device (K200947). The exact location or nature (retrospective/prospective) of these non-clinical tests is not specified beyond "ex-vivo tissue testing."

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

• This information is not provided in the document. Given that the testing detailed is primarily ex-vivo and bench testing, rather than a clinical trial requiring human interpretation of results against a gold standard, this type of expert review is typically not part of these types of 510(k) submissions.

4. Adjudication Method for the Test Set

• This information is not provided. As above, for non-clinical, ex-vivo, and bench testing, a formal adjudication process using multiple experts is generally not applicable in the same way it would be for clinical image interpretation or diagnosis.

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

• No, a MRMC comparative effectiveness study was not done. The document states, "No clinical data was submitted." The submission relies on non-clinical performance data and substantial equivalence to legally marketed predicate devices.

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

• This device is not an AI algorithm. It is a physical medical device (radiofrequency technology for dermatological applications). Therefore, the concept of "standalone algorithm performance" is not applicable here. The "performance" refers to the device's physical and functional capabilities.

7. The Type of Ground Truth Used

• For the ex-vivo tissue testing, the "ground truth" would be the physical measurement and visual assessment of the fractional coagulation necrosis pattern in the tissue. This is a direct physical effect, not an expert consensus or pathology report in the traditional sense for diagnostic AI. For electrical, mechanical, and EMC testing, the "ground truth" would be the defined standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no training set for this device.

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The InMode System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-V.

The InMode System with the Morpheus8 Applicators is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Morpheus8 Applicators (K200947), inclusive of minor software modifications, cleared in K210492 and K221571. The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The device has two Applicators which can be connected to the platform, one at the time. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use 12, 24, and T tip head accessories. The Morpheus8 Body Applicator is identical except that the compatible tip head is a 40 pin tip head.

The provided text is a 510(k) summary for the InMode System with Morpheus8 Applicators. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K200947), rather than conducting a new study to prove a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, which would typically be found in an AI/Software as a Medical Device (SaMD) submission.

Therefore, the requested information about acceptance criteria, study details (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training set details for a new device's performance study cannot be extracted from this document. This submission leverages prior testing of the predicate device and argues that no new performance data or clinical data is needed because the current device is substantially equivalent and the changes are minor (e.g., expansion of indications based on energy levels).

Here's what can be inferred and a clear statement of what is missing:

What can be extracted/inferred:

• Device Type: The device is an electrosurgical cutting and coagulation device, specifically using Radiofrequency (RF) technology. It's intended for dermatologic procedures requiring coagulation/contraction of soft tissue or hemostasis. This is a hardware device, not an AI/SaMD.
• Purpose of current submission: This is a "Special 510(k) notice" for an expansion of indications for use based on higher energy levels (greater than 62 mJ/pin) and limiting use to Skin Types I-V for the Morpheus8 Applicator.
• Performance Data Submitted (Leveraged from Predicate):
  • Bench Testing: An ex-vivo tissue study was conducted on two different harvested porcine tissues (muscle and fat) to evaluate the performance and safety of the Morpheus8 Applicators. The study involved biopsy sampling and staining to visualize the tissue coagulation necrosis pattern.
  • Standards Compliance: The device complies with several voluntary recognized standards related to medical electrical equipment (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2).
  • Prior Testing (from K200947): Software validation testing, electrical and mechanical safety testing, comparative bench testing, and ex-vivo tissue testing to evaluate the fractional coagulation necrosis pattern.
• Ground Truth (for the ex-vivo study): The ground truth appears to be based on visualizing the "tissue coagulation necrosis pattern" through biopsy sampling and staining. This would be a direct physical observation of the tissue's response to the device.
• Clinical Performance Data: Explicitly stated as "Not Applicable" for this submission.
• Animal Performance Data / Histology Data: Explicitly stated as "No new animal performance data is submitted to support this submission."
• Training Set/Test Set (as it relates to AI/ML): Not applicable, as this is a hardware device submission, not an AI/ML algorithm.

Information NOT present in the document (and why):

1. Table of acceptance criteria and reported device performance: This document does not describe acceptance criteria for metrics like accuracy, sensitivity, specificity, or similar quantitative performance outcomes typical for diagnostic or AI/ML devices. Instead, the "acceptance" is demonstrated by substantial equivalence to a predicate device and compliance with safety and performance standards for an electrosurgical device. The ex-vivo study concludes that the applicators "perform as intended for the specified indications," but no specific numerical performance metrics are given.
2. Sample size used for the test set and data provenance: The ex-vivo study mentions "two different harvested porcine tissues," but does not specify the sample size (e.g., number of tissue samples, number of treatment applications). Data provenance is "ex-vivo tissue study" (animal tissue, not human patient data), origin not specified beyond "harvested."
3. Number of experts used to establish ground truth & qualifications: Not applicable to ex-vivo studies of this nature using physical staining and observation, unless a subjective assessment by experts was performed (not indicated here).
4. Adjudication method: Not applicable/not described.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted, as this is a hardware device, not an AI/assisted reading device. Therefore, no effect size of human readers improving with AI assistance is reported.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a device that requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the ex-vivo study, the ground truth was directly observed and visualized "tissue coagulation necrosis pattern" through biopsy and staining. This is akin to a pathological or direct physical outcome.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, this 510(k) submission is for a physical medical device (an RF electrosurgical system) and therefore does not contain the information typically required for an AI/Software as a Medical Device (SaMD) submission regarding AI model performance, training sets, and expert consensus-based ground truth for diagnostic accuracy. The "study" referenced is an ex-vivo tissue study to demonstrate the physical effect of the device on tissue, supporting its intended use.

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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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The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis.

At higher energy levels greater than 62 ml/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-V.

The InMode System with the Morpheus8 (Fractora) Applicators is a computerized, programmed, RF technology-based device intended for dermatological applications which requires skin electrocoagulation and hemostasis.

The device platform is basically constituted on the same system platform as FDA cleared for the proposed predicate device; The InMode System with the Fractora3D/3D-90 Applicators (K180189). The device applicators employ fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morphues8 (Fractora) Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins.

The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 (Fractora) Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 (Fractora) Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The subject device applicator comprises a disposable, single use, fractional RF electrode pins tip head.

The InMode System with the Morpheus8 (Fractora) Applicators comprises the following applicator tip heads:

• Morpheus8 24 Pin Applicator (Fractora3D) tip (FDA Cleared in K180189)
• Morpheus8 40 Pin treatment tip (New tip) .
• . Morpheus8 12 Pin treatment tip (New tip)
• . Morpheus8 T Pin treatment tip (New tip)

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "InMode System with the Morpheus8 (Fractora) Applicators." It establishes the substantial equivalence of this new device to a previously cleared predicate device.

Crucially, this document is for an electrosurgical cutting and coagulation device, not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance, such as ground truth, multi-reader multi-case studies, training sets, and expert consensus, are not applicable to the information contained in this document.

The primary acceptance criteria for this type of device, as per the document, revolve around substantial equivalence to a predicate device in terms of:

1. Intended Use/Indications for Use
2. Technological Characteristics
3. Safety and Effectiveness (demonstrated through performance testing and compliance with recognized standards).

Here's a breakdown of the relevant information provided in the document concerning the device's acceptance criteria and the study proving it meets those criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (InMode System with the Fractora3D/3D-90 Applicators, 510(k) No. K180189). The 'studies' are non-clinical bench performance tests.

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or image-based AI/ML test set. The 'test set' here consists of the subject device (InMode System with new Morpheus8 applicators) comparing its performance and characteristics against the predicate device.
• Data Provenance: The tests are non-clinical bench performance tests. Data is proprietary to the manufacturer (InMode MD Ltd.) and was collected as part of their device development and regulatory submission process. There is no mention of country of origin for data related to patients or clinical studies, as none were required or performed. The tests are "retrospective" in the sense that they were performed after the device was manufactured to verify its specifications.

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

• This is not applicable as there is no "ground truth" established by experts in the context of an AI/ML device for diagnostic purposes. The ground truth for performance here is the physical output of the device and its compliance with engineering specifications and recognized safety standards, measured by calibrated equipment.

4. Adjudication Method for the Test Set

• Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or labelers, typically in image interpretation for AI/ML ground truth generation. Here, the "test" is largely a comparison of engineering specifications and performance with those of a predicate device and relevant standards.

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

• No. This type of study is for evaluating human performance, often with and without AI assistance, especially in diagnostic imaging. It is not relevant for an electrosurgical device like the InMode System.

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

• Not applicable. There is no "algorithm" in the sense of an AI/ML model being assessed independently. The performance assessed is the device's physical output and adherence to safety standards.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for this device's performance evaluation comprises:
  • Engineering Specifications: The design parameters and operational capabilities of the device as per its intended function (e.g., RF output power, frequency, energy per pin, dimensions).
  • Recognized Consensus Standards: Compliance with international standards for medical electrical equipment (IEC 60601 series, AAMI/ANSI standards) and sterilization (ISO 11137-1).
  • Predicate Device Performance: The established performance and safety characteristics of the legally marketed predicate device (K180189) serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As no training set is involved, no ground truth needed to be established for it.

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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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BIOGENNIX osteoSPAN Morpheus 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, posterolateral spine and pelvis). These defects may be surgically created 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. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hvdroxvapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder used in osteoSPAN Morpheus facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.

The provided document is limited in scope and only describes the OsteoSPAN Morpheus device and its expanded indication for use. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

However, I can extract what is available and indicate what information is missing.

Here's a summary based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through supplementary preclinical performance testing. The reported performance is a qualitative assessment of this equivalence.

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

The document states "Supplementary preclinical performance testing confirmed..." but does not provide details on the sample size for this testing. It only mentions the "posterolateral spine model."

The data provenance is within the context of a 510(k) submission to the FDA, suggesting the data was generated specifically for supporting this regulatory submission. It does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable/Not provided. The document describes preclinical performance testing in a "posterolateral spine model," implying animal or in-vitro models were used, rather than human data requiring expert ground truth establishment for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As the testing appears to be preclinical performance testing, an adjudication method for human interpretation of results is not relevant or described.

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

No. The document does not mention any MRMC study or any study involving human readers with or without AI assistance. This device is a bone void filler, not an imaging or diagnostic AI device.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical device (bone void filler), not an algorithm or AI. The concept of "standalone performance" for an algorithm does not apply here.

7. Type of Ground Truth Used

For the preclinical performance testing, the "ground truth" would likely be based on:

• Histopathology/Microscopic analysis: To assess bone ingrowth and tissue reaction in the experimental models.
• Mechanical testing standards: For measuring mechanical strength.
• Material analysis techniques: For determining residual material.

However, the specific methods for establishing this "ground truth" are not detailed in the document beyond stating "preclinical performance testing confirmed."

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a physical medical device and does not involve AI or machine learning models that require a "training set."

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

Not applicable/Not provided. (See point 8).

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BIOGENNIX osteoSPAN Morpheus 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.

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hydroxyapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.

The provided text describes a 510(k) summary for a medical device called osteoSPAN Morpheus, a resorbable calcium salt bone void filler. The submission does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Technological characteristics comparison: A table comparing osteoSPAN Morpheus to a primary predicate (osteoSPAN granules) and a material-reference predicate (Actifuse ABX E-Z-fil Putty) across several characteristics (Calcium Salt, Granule Size, Porosity, Polymer Binder, Osteoconductive).
2. Safety and performance testing: "Chemical and physical testing confirmed acceptable findings and were consistent with prior osteoSPAN predicate device qualifications. Biogennix osteoSPAN Morpheus was thoroughly evaluated for biocompatibility in accordance with ISO 10993 appropriate parts and for performance, through multiple non-clinical in-vivo and ex-vivo studies."

Since this is a conventional medical device submission rather than an AI/ML device, the specific questions regarding AI/ML device performance (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.

Therefore, I cannot provide the requested information from the given text.

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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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