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The Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of relative compartment compressibility.
The relative compartment compressibility (CP Value) is not meant for trend analysis.

The Compartmental Compressibility Monitoring System (CPM#1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility.
The device combines a linear ultrasound array with an integrated pressure sensor into a single handheld probe (CP Probe) to obtain cross-section ultrasound views of the compartment of interest. The device provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure.
Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria with a comparison table. The "Performance Data" section lists several types of testing performed but does not quantify acceptance criteria or present the results in a comparative manner with specific metrics.

However, based on the types of performance data mentioned and the overarching purpose of a 510(k) submission, we can infer some general categories of acceptance criteria and the nature of the "studies" conducted.

Here's an attempt to answer the questions based on the available information, noting where details are not provided:

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

The document does not provide a table of acceptance criteria with specific quantitative targets and corresponding reported device performance for the CPM#1 System's functional output (CP Value). It lists types of tests conducted:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• CP Value Performance (Clinical Testing): "A study was performed to validate the repeatability and reproducibility of the CPM#1 System relative compartment compressibility measurements in healthy volunteers."
  • Sample Size: Not specified.
  • Data Provenance: Not specified (country of origin or retrospective/prospective). Given it's a "study...in healthy volunteers," it is typically prospective.
• CP Value Performance (Bench Test Model): "The accuracy, repeatability, and reproducibility of the CP Value was confirmed using an in-vitro bench test model."
  • Sample Size: Not specified (for the bench test).
  • Data Provenance: Not applicable as it's an in-vitro test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The device measures "relative compartment compressibility" (CP Value) as a direct output. The ground truth for CP Value performance would likely come from established measurement techniques/standards for compressibility in the bench model, and the clinical study would assess repeatability and reproducibility of the device's own measurements, not against an expert-established ground truth for a diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is relevant for studies where expert interpretation or consensus is required to establish ground truth for a diagnostic task. The CPM#1 System directly measures a physical property (compressibility) and its performance is assessed based on the accuracy, repeatability, and reproducibility of these measurements.

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

No MRMC comparative effectiveness study was mentioned. The device is not an AI-assisted diagnostic tool that human readers would use to improve their performance over a baseline. It is a measurement device.

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

Yes, the various performance tests listed (Biocompatibility, Electrical Safety, Usability, Cleaning and Disinfection, Ultrasound Performance, and particularly CP Value Performance) describe the standalone performance of the device and its algorithms. The CP Value is "calculated and displayed on-screen as the CP Value" by the device itself.

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

• CP Value Performance (in-vitro): The ground truth for accuracy, repeatability, and reproducibility would be established by the design specifications of the device and reference standards or methods for measuring compressibility in the bench model.
• CP Value Performance (clinical): The clinical study assessed the repeatability and reproducibility of the device's own measurements in healthy volunteers, rather than comparing against a clinical "ground truth" diagnosis, as the "CP Value is not meant for trend analysis" and not for diagnosis of compartment syndrome.

8. The sample size for the training set

Not applicable. This device does not appear to be an AI/machine learning-based diagnostic device that requires a training set in the conventional sense. Its "performance" relies on the accuracy and precision of its physical sensors and calculations.

9. How the ground truth for the training set was established

Not applicable, as it's not an AI/machine learning device with a training set.

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The VPS Rhythm® DLX Device is indicated for the positioning of central venous catheters including PICCs. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm DLX® Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.

The TipTracker™ Technology is an optional accessory for use with the VPS Rhythm® DLX Device, indicated for visual navigation of a peripherally inserted catheter (PICC) as it is threaded through the vasculature. The TipTracker™ technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

For a catheter insertion procedure, ultrasound may optionally be used to assess the blood vessel to aid in selection of catheter size and visualize the blood vessel during initial insertion.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave: including

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-driven rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The VPS Rhythm® DLX Device with TipTracker™ Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm® DLX Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.

The optional Tip TipTracker™ Technology includes the software algorithms and accessory components (the non-sterile, reusable TipTracker™ T-piece and sterile, single-use TipTracker™ and proposed NaviCurve™ Stylet) which facilitate the real-time visualization of a Peripherally Inserted Central Catheter's (PICC) track and direction as it is inserted by the clinician through the vasculature. The TipTracker™ T-piece consists of a magnetic emitter array that is connected to the VPS Rhythm® DLX Device monitor. In use, the TipTracker™ T-piece is placed externally on the patient's chest. When the sterile, single-use TipTracker™ Stylet or NaviCurve Stylet is assembled with the peripherally inserted central catheter (PICC) and inserted by the clinician, the VPS Rhythm® DLX Device with TipTracker™ Technology facilitates the visualization of the PICC's insertion track and direction relative to the location of the TipTracker™ T- piece. The TipTracker™ Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final catheter tip location.

The proposed VPS Rhythm® DLX Device introduces the ability to pair a commercially available Ultrasound probe (Interson Corporation: K163443) with the VPS Rhythm® DLX monitor to permit ultrasound visualization during the initial central catheter insertion procedure for vessel assessment and visualization on the display of the VPS Rhythm® DLX system. An optional catheter to vessel ratio tool can be used during vessel assessment.

As a new optional feature related to P-wave morphology changes, the DLX Software uses a time detected reference based on the R-Peak to show where the P-wave should exist in a patient with a normal sinus rhythm.

The provided text, a 510(k) summary for the VPS Rhythm® DLX Device with TipTracker™ Technology, describes the device and its demonstrated equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request, particularly a table of acceptance criteria with reported performance, or details about patient sample sizes, expert adjudication, or MRMC studies.

The document focuses on demonstrating substantial equivalence to an existing predicate device (VPS Rhythm® Device with TipTracker™ Technology, K160925) by highlighting non-clinical performance data and the absence of new safety or effectiveness concerns due to the modifications.

Here's a breakdown of what can be extracted from the document regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it broadly states that "testing verifying the performance requirements of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted and included in this premarket notification and the results support substantial equivalence."

The types of testing performed can be inferred as fulfilling the acceptance criteria, as the document concludes that the testing "has passed all acceptance criteria to verify that the proposed VPS Rhythm® DLX Device with TipTracker™ Technology meets its design, physical integrity, functional, software, and safety requirements."

Inferred "Acceptance Criteria" based on tests mentioned:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify a sample size for the test set for any of the non-clinical performance tests. It refers to "Human Factors: A human factors and usability report assessing the usability of the subject VPS Rhythm® DLX Device with TipTracker™ Technology was conducted. The studies conducted utilized independent clinician participants to assess the primary operating functions of the proposed device against the predetermined usability criteria." However, it does not state the number of participants.
• Data Provenance: The document explicitly states: "No human clinical data was provided to support substantial equivalence." The data described is "Non-Clinical Performance Data," implying in-vitro and bench testing, as well as a human factors study which involves users, not patients. Therefore, information regarding "country of origin of the data," "retrospective or prospective," or "patient samples" is not applicable based on what is provided.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable, as no human clinical data was provided and the human factors study involves participants for usability assessment, not for establishing medical ground truth for device accuracy.
• Qualifications of Experts: The human factors study used "independent clinician participants," but no specific qualifications (e.g., "radiologist with 10 years of experience") are provided.

4. Adjudication Method for the Test Set:

• Not applicable, as no clinical ground truth was established by experts for medical performance. The human factors study assessed usability against "predetermined usability criteria," implying internal validation, but no multi-expert adjudication process is described for device performance accuracy.

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

• No MRMC study was done. The document explicitly states: "No human clinical data was provided to support substantial equivalence." Therefore, there is no information on human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance:

• The document describes the device's overall performance in various non-clinical tests (e.g., "ECG Waveform Performance," "Tracking Display," "Ultrasound Display"). Since no human clinical data was presented, the "performance" described is effectively the "algorithm's" or device's inherent capability as measured in bench and engineering tests. However, it does not isolate "algorithm-only" performance as a separate study component distinct from the integrated device. The device itself uses the cardiac electrical activity and magnetic field technology for its functions.

7. Type of Ground Truth Used:

• For the non-clinical performance data, the ground truth is implicitly defined by the standards and specifications against which the device was tested (e.g., IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC53, ISO 11070, ISO 10993-1). These standards represent established engineering and safety benchmarks for medical devices.
• For the human factors study, the "ground truth" was predetermined usability criteria.

8. Sample Size for the Training Set:

• The document describes a 510(k) submission for a device that uses cardiac electrical activity and magnetic field technology, and mentions "software algorithms." However, it does not state that the device uses machine learning or AI that requires a "training set" in the typical sense of supervised learning. The software V&V refers to traditional software testing. Therefore, information on a training set size is not provided and likely not applicable in the context of this traditional medical device clearance.

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

• As a "training set" for AI/machine learning is not mentioned as part of the device's development or clearance, this information is not applicable and not provided. The device's functionality is based on known physiological principles (ECG changes to detect catheter tip location) and magnetic field-based tracking, rather than data-driven "learning" from a large dataset.

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The THD Procto Software is a software that can be used:

· In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.

· In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol

The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories (endoanal probe and video camera), is able to be applied for:

• Endoanal ultrasound (→ trans-rectal ultrasound / echography) -
• -Anoscopy exams,

During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; Durinq Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camera;

The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below:

• Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below
• . Endoanal Ultrasound Module, which manages:
  • The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video
  • Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing,
  • The examination report (medical history, comments, conclusions) and the printing O
• Anoscopy Exams module, which manages:
  • Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen
  • Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing
  • The examination report (medical history, comments, conclusions) and the printing o

Here's a breakdown of the acceptance criteria and study details for the THD Procto Software System, based on the provided document. Please note that the document is a 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies typical for novel AI/ML devices. Therefore, some information, particularly regarding specific performance metrics and AI/ML evaluation methodologies, is not present. The device appears to be primarily an imaging and diagnostic system with software for processing and recording, not an AI/ML diagnostic algorithm that would have specific performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria and Device Performance

The provided document (a 510(k) summary) doesn't explicitly state quantitative acceptance criteria in the typical sense of a pre-defined performance threshold for an AI/ML algorithm (e.g., "sensitivity must be >X%"). Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to predicate devices for its intended use as an ultrasonic pulsed echo imaging system and for anoscopy exams.

Therefore, the "reported device performance" is largely demonstrated through a comparison of technological characteristics and intended uses with legally marketed predicate devices, rather than through specific performance metrics like accuracy, sensitivity, or specificity.

Table of Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence)

Since the device is cleared via 510(k) substantial equivalence, the "acceptance criteria" revolve around demonstrating that the device is as safe and effective as the predicate. The "reported device performance" is the assertion of meeting these equivalence points.

Study Details (Based on the 510(k) Summary)

It's crucial to understand that a 510(k) summary is not a detailed scientific study report. It summarizes the basis for substantial equivalence to a predicate device. Therefore, explicit information about a "study" in the typical clinical trial sense, especially for AI/ML performance, is not present for this device. The information provided below is a reconstruction based on typical 510(k) submission practices rather than an explicit description of a performance study within the document.

1. Sample size used for the test set and the data provenance:

• Not explicitly stated. For a 510(k) submission based on substantial equivalence of an imaging system rather than a diagnostic AI algorithm, there isn't typically a "test set" in the sense of a dataset used for performance evaluation against ground truth. Equivalence is primarily based on technical characteristics, rather than performance on a clinical dataset.
• The document implies that the device works by acquiring and processing real-time ultrasound signals and camera inputs, suggesting its function is akin to a medical device instrument rather than a standalone AI diagnostic tool evaluated on a pre-defined test set.

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

• Not applicable/Not stated. Given the nature of a 510(k) for an imaging system, ground truth establishment by experts for a "test set" is not detailed in this summary. The device's function is to provide images and measurements, not to interpret them autonomously.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not stated. No test set or associated adjudication method is mentioned in this 510(k) summary.

4. 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:

• No evidence. This document does not describe an MRMC study. The THD Procto Software System appears to be an imaging and measurement software rather than an AI-assisted diagnostic tool that would typically undergo such a study.

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

• No evidence. The document describes a system involving a human operator (inserting probes, acquiring signals, using the software for processing and recording). There is no mention of a standalone algorithm or its performance.

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

• Not applicable/Not stated. The document does not describe performance evaluation against a specific type of ground truth in the context of an AI/ML diagnostic claim. The device aims to visually present anatomical structures and allow for measurements, for which the "ground truth" is typically the real-time anatomical structures themselves as visualized by the medical professional.

7. The sample size for the training set:

• Not applicable/Not stated. The document does not describe a training set, suggesting this device is not based on a machine learning model that requires a training set. It appears to be a functional image acquisition, processing, and recording software.

8. How the ground truth for the training set was established:

• Not applicable/Not stated. As no training set is mentioned, ground truth establishment for it is not discussed.

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