Search Results

The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.

The Vaginal Tactile Ultrasound Imager (TIUSv) acquires ultrasound images and tactile images (pressure maps) from within the vagina and assesses the strength of pelvic floor muscles within the vagina. The device provides data on the pressures applied to vaginal walls along with the probe location to visualize pelvic floor support structures, and to record pelvic floor muscle contraction. The TIUSv software provides measurement, imaging, and reporting tools. The acquired data and the analysis results provided by TIUSv software can be used by a physician for quantitative biomechanical assessment of the vagina and pelvic floor conditions. The TIUSv probe is equipped with 96 pressure (tactile) sensors, 192 ultrasound transducers, an orientation sensor (accelerometer), temperature sensors, and micro-heaters. During the clinical procedure, the probe is used to acquire dynamic ultrasound images and pressure responses from the vaginal walls under applied loads. The TIUSv examination procedure includes data collection from all segments of the vagina. Real-time data are sampled from the probe sensors via the interface electronics. The TIUSv software displays the acquired data in real time. The resulting pressure maps (tactile images) of the vagina integrate all the acquired pressure and positioning data for each of the pressure sensing elements. The TIUSv records the dynamic contraction for pelvic floor muscle(s). The probe surfaces that contact the vaginal walls are preheated to human body temperature. The TIUSv supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The TIUSv also provides data and graphs such as pressure applied to the probe and location, resting pressures, muscle contraction pressures and calculated pressure gradients.

The FDA 510(k) clearance letter for the Vaginal Tactile Ultrasound Imager (TIUSv) (K231875) (pages 0-10) indicates that the device's performance was evaluated through various tests, but it does not provide a detailed study proving the device meets specific acceptance criteria for its diagnostic capabilities (e.g., accuracy in assessing pelvic floor muscle strength or identifying abnormalities using ultrasound).

Instead, the documentation focuses on:

• Bench testing for measurement accuracy of pressure, temperature, and orientation.
• Safety and engineering compliance (biocompatibility, electrical safety, EMC, cleaning/disinfection validation).
• Software verification and validation.
• Comparison to a predicate device (Vaginal Tactile Imager K142355) and a reference device (Acuson Ultrasound System) to establish substantial equivalence.

While the document states, "The real-time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation," it does not present clinical study results from human subjects to establish the device's diagnostic performance relative to acceptance criteria in terms of sensitivity, specificity, accuracy, or its impact on human reader performance.

Therefore, the following sections will be based on the information provided in the document, acknowledging the absence of clinical diagnostic performance data.

Acceptance Criteria and Reported Device Performance

As specific diagnostic performance acceptance criteria from a clinical study are not provided, the table below focuses on the measurement performance acceptance criteria that were met through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance (Measurement)

2. Sample Size for the Test Set and Data Provenance

The provided document details various engineering and bench tests, along with software verification and validation. It does not describe a 'test set' in the traditional sense of a clinical dataset of patients assessed by the device for diagnostic performance. The performance data presented (e.g., pressure accuracy, ultrasound resolution) are derived from bench testing as indicated in Section 6, "OVERVIEW OF THE PERFORMANCE DATA." Therefore, there is no patient-specific sample size, country of origin, or information on retrospective/prospective data collection for diagnostic efficacy evaluation.

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

Since the document focuses on bench testing and engineering verification, no experts were used to establish ground truth for a clinical test set. The "ground truth" for the reported measurement accuracies (pressure, temperature, orientation) would have been established using precisely calibrated instruments and phantom models during laboratory bench testing.

4. Adjudication Method for the Test Set

As there was no clinical "test set" requiring human interpretation or diagnosis, no adjudication method was used or described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this documentation. The clearance is based on substantial equivalence to a predicate device, and engineering/bench testing, not on clinical efficacy beyond what is needed to demonstrate equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone performance study of an AI algorithm in the context of diagnostic accuracy. The device provides "visualization, analysis tools and information" to assist physicians, suggesting a human-in-the-loop use case. The reported performance metrics are for the device's physical measurement capabilities, not an AI algorithm's diagnostic output.

7. Type of Ground Truth Used

For the reported measurement performance (e.g., pressure, temperature, orientation accuracy, ultrasound resolution), the ground truth was established through calibrated reference instruments and defined test conditions during bench testing and engineering verification. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for diagnostic accuracy in patient populations.

8. Sample Size for the Training Set

The document does not mention any training set size, as it does not describe an AI/machine learning model whose diagnostic performance was evaluated from a clinical dataset. The software verification and validation refer to general software development practices (e.g., IEC/EN 62304), not the training of a predictive model.

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

As no training set is described for an AI/machine learning model, there is no information on how ground truth was established for such a set.

Ask a specific question about this device

The Vaginal Tactile Imager obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.

The Vaginal Tactile Imager (VTI) obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical clinical setting to sense the pressure along the vagina and store the corresponding data. The VTI also provides analysis information. The real time data as well the analysis information can then be viewed by a physician as a tool for diagnosis and analysis.

During the clinical procedure, the probe is inserted in the vagina for measurement of pressures on the vaginal wall at rest and pelvic floor muscle contractile pressures. Real time data is sampled from each sensing element via the VTI interface electronics and made available to the VTI software during each sample period. The software displays the data in real time to support the clinical procedure. The software also supports operational utility functions such as providing the user with an interface for operating the pressure calibration system. It obtains the probe sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection.

The VTI supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The VTI also indicates measured parameters such as high pressure zone location and size, resting pressures, muscle contraction pressures and calculated pressure gradients.

The provided text describes the Vaginal Tactile Imager (VTI), a device intended to obtain a high-resolution mapping of pressures and assess the strength of pelvic floor muscles within the vagina. However, the document does not explicitly state acceptance criteria or a detailed study proving the device meets specific quantitative performance acceptance criteria.

The document primarily focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices, and outlines general performance testing and clinical studies to demonstrate safety and functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The text describes "performance testing" and "clinical studies" but does not define quantitative acceptance criteria or provide specific numerical performance results.

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

• Sample Size for Clinical Studies (Test Set): "Twenty-two women provided data from 32 procedures with the device." This refers to a "feasibility study evaluating the final version of the subjects."
• Data Provenance: The document does not explicitly state the country of origin. It mentions "Advanced Tactile Imaging, Inc." with an address in Trenton, NJ, USA, which implies the studies were likely conducted in the USA. The studies were described as "clinical studies," and one specifically as a "feasibility study," suggesting a prospective nature.

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

This information is not provided in the document. The document mentions the device is intended for use by "physicians, surgeons and medically trained personnel" and that analysis information can be viewed by a "physician," but it does not specify how ground truth for the clinical studies (e.g., diagnosis of pelvic floor disorders) was established or by how many experts of what qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This information is not provided in the document. The clinical studies mentioned focused on safety, comfort, and the device's ability to perform its core functions (tactile imaging, recording muscle contractions), not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document describes the VTI as a device that "obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles... It also provides visualization, analysis tools and information." The data and analysis information ""can then be viewed with an intention of assisting in the diagnosis and evaluation." This strongly implies that the device is a tool for clinicians, not a standalone diagnostic algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI deployments in diagnostics was likely not performed or applicable for this device as presented. The device itself is the "algorithm" that processes and displays pressure data.

7. Type of Ground Truth Used

The document mentions two groups of women in the feasibility study: "(1) those with no evidence of pelvic floor disorder and no prior pelvic surgery and (2) those with stage 1 or 2 pelvic organ prolapse." This implies that clinical diagnosis (e.g., by a physician based on clinical examination) was used to categorize these groups, which would serve as the ground truth for evaluating the device's ability to provide relevant information in these populations. There is no mention of pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes "various prototypes" being used in clinical studies, but it does not detail any specific training set for a machine learning model, as the VTI itself is described as an imaging and analysis tool, not necessarily an AI-driven diagnostic algorithm in the contemporary sense. Calibration processes are mentioned, but not a separate "training set" for a diagnostic algorithm.

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

Since no specific training set or explicit machine learning component for diagnosis is detailed, this information is not provided and likely not applicable in the context of this device's description. The "correction factors" for calibration are determined from "probe sensor and calibration chamber data" during a calibration process, which is distinct from establishing ground truth for a diagnostic algorithm's training.

Summary of Missing Information:

The core request for explicit acceptance criteria and corresponding numerical performance data from a specific study is not present. The document focuses on regulatory clearance via "substantial equivalence" and general safety and functionality rather than detailed quantitative performance metrics for a diagnostic claim.

Ask a specific question about this device