(276 days)
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.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).