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The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.

The FemDx FalloView™ is a disposable, hand-held, battery-operated endoscope that contains a 4.7 mm hysteroscopic cannula, a 1.2 mm falloposcopic catheter, and a visualization system. The catheter is integrated inside the cannula center lumen and can be deployed, retracted, or rotated. The cannula includes a lumen and a proximal female luer lock port for saline irrigation. The visualization system includes a camera module positioned at the tip of the catheter, a controller board, an LCD display integrated into the device's handle, and LED/fiber optic illumination. The FemDx FalloView™ contains embedded software designed to display the real time image on the LCD display, control the illumination light level, and capture a screenshot. The captured image can be transmitted to a computer via Bluetooth and then accessed using the FalloView™ Image Viewer, a separate PC based software application.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against predefined performance targets.

Specifically, it states that "The FemDx FalloView™ passed all applicable testing in accordance with internal requirements and national and international standards. The results demonstrate that the FemDx FalloView™ satisfies the performance, functional, and safety requirements relative to the product specifications, risk analyses, and Instructions for Use, and does not raise different questions of safety and effectiveness than the predicate device." However, it does not quantitatively report on device performance against specific, numerically defined acceptance criteria.

The document lists various non-clinical tests performed, such as "Image quality comparative testing" (including field of view, resolution, depth of field, etc.), "Flow rate and leakage testing," "Dimensional testing," and "Mechanical testing," but it does not provide the specific acceptance criteria for these tests nor the quantitative results that prove the device met them.

Therefore, it is impossible to complete the requested table and answer the specific questions based solely on the provided text. The document confirms that testing was done to demonstrate safety and effectiveness and substantial equivalence, but it does not detail the acceptance criteria or the specific statistical results of studies against those criteria.

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The STARRT System is indicated for use as a secondary diagnostic tool for the further evaluation of women previously diagnosed with proximal tubal occlusion by hysterosalpingography or selective salpingography.

The Conceptus Stargate Catheter is a single lumen device with a graded shaft flexibility. The distal end has a diamond shaped wire tip designed to guide the catheter and to keep fallopian tube epithelium away from the falloposcope lens during imaging. The hub located at the proximal end of the Conceptus Stargate Catheter has two ports. The sideport is used for the attachment of the Trifurcated Irrigation Tubing set. The endport serves as a conduit for the introduction of the Conceptus Falloposcopy Guidewire and Falloposcope.

The Conceptus Stargate Catheter and Falloposcopy Guidewire are transcervically delivered into the fallopian tube ostium through the lumen of the Coaxess™ Catheter which is delivered into the uterine cavity through the working channel of a rigid hysteroscope and positioned at the tubal ostium under hysteroscopic guidance. The Conceptus Stargate Catheter and Falloposcopy Guidewire are designed for use within the proximal portion of the fallopian tube (the first 2-3 cm of the tube).

The provided document describes the Conceptus Stargate™ Falloposcopy Catheter and Trifurcated Irrigation Tubing Set, which is part of the STARRT™ Falloposcopy System. This system is intended as a secondary diagnostic tool for evaluating women with proximal tubal occlusion.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with numerical targets. Instead, it focuses on demonstrating substantial equivalence to an existing cleared device (Conceptus VS™ Catheter) and qualitative improvements. The performance is largely framed around safety and effectiveness comparable to, or better than, the predicate device.

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

• Laboratory Testing: No specific sample size is provided for the laboratory tests on force and kinking.
• Preclinical (Animal) Study: "A fallopian tube catheterization histology study in rabbits was conducted." The exact number of rabbits or fallopian tubes is not specified, but it compares "catheterized and control tubes."
• Clinical Testing: The document states that "clinical testing was conducted." No specific sample size (number of patients or procedures) is provided for this clinical testing.
• Data Provenance: The document does not explicitly state the country of origin for the data. Given Conceptus, Inc. is located in San Carlos, CA, USA, it is highly probable the studies were conducted in the USA. The studies appear to be prospective as they were conducted to validate the new device.

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

• Laboratory/Preclinical: Ground truth for these studies would be based on scientific measurements (forces, histological analysis). Experts in materials science or pathology would be involved, but specific numbers or qualifications are not stated.
• Clinical Testing: "Participating clinicians reported that they were able to make a better diagnosis." The number of clinicians is not specified. Their qualifications are implied as "clinicians with experience in tubal evaluation" (from the Indications for Use), but specific details (e.g., "radiologist with 10 years of experience") are not provided. The ground truth for improved diagnosis is based on their expert clinical assessment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical testing. The statement "Participating clinicians reported that they were able to make a better diagnosis" suggests a direct assessment by the clinicians during their use of the device, rather than a separate adjudication process of diagnostic outputs.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not describe a formal Multi Reader Multi Case (MRMC) comparative effectiveness study. While clinical testing compared the Stargate to the VS Catheter and clinicians reported an improvement, it's not presented as a structured MRMC study designed to quantify the effect size of human readers' improvement with AI vs. without AI assistance. This device is a catheter, not an AI diagnostic tool, so the concept of "human readers improve with AI" is not directly applicable here.

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

This device is a medical instrument (catheter), not a software algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this submission. Its performance is intrinsically tied to human operation.

7. The Type of Ground Truth Used

• Laboratory Testing: Objective measurements (force, kink resistance).
• Preclinical (Animal) Study: Histopathology (microscopic examination of tissue samples for damage).
• Clinical Testing: Expert clinical assessment/diagnosis by participating clinicians. This falls under expert consensus/clinical judgment.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a mechanical instrument, and its development and testing followed traditional medical device validation pathways, not AI model development.

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

As there is no mention of a training set for an AI model, this question is not applicable to the provided document. The development of the Stargate Catheter relied on engineering design, laboratory testing, preclinical studies, and clinical observations rather than machine learning training.

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The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.

The Imagyn Falloposcopy System consists of the following components:
Linear Everting (LE) Fallopian Tube Access Catheter
Falloposcope

I am sorry, but the provided text does not contain sufficient information to describe the acceptance criteria and the study that proves the device meets those criteria in the structured format you requested.

The document is a 510(k) summary for the Imagyn Falloposcopy System and primarily focuses on:

• Identification of the device and manufacturer.
• Identification of predicate devices.
• Description of the device and its intended use.
• Technological comparisons to predicate devices.
• A general statement that "Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use."

However, it does not provide details on:

• Specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
• Any performance metrics achieved by the device.
• Sample sizes for test sets or training sets.
• Data provenance.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether MRMC studies were performed.
• Whether standalone algorithm performance was assessed (the device described is a physical medical device, not an AI algorithm).
• The type of ground truth used (beyond the general statement of "clinical tests").
• How ground truth for the training set was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study design with the given input.

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The Conceptus FTCM System is intended for use in selective catheterization/cannulation of the fallopian tubes in order to evaluate proximal tubal occlusion or patency under direct visualization.

The FTCM System combines well-established procedures of HSG, co-axial catheterization and microendoscopy. The FTCM System is composed of the following components: Soft Seal Cervical Catheter, Soft Torque Uterine Catheter and Accessory Valve, and/or Articulating Tip Hysteroscope, Variable Softness Catheter, guidewires: the Robust Guidewire, the Traveler Guidewire, the Supple Guidewire and the Pirouette Guidewire, and a Microendoscope with Eyepiece.

The provided text describes a medical device, the FTCM System, and states its intended use. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria.

The document focuses on:

• Device Description: Detailed breakdown of each component of the FTCM System (Catheters, Hysteroscope, Guidewires, Microendoscope, Eyepiece).
• Indications for Use: What the device is intended for (selective catheterization/cannulation of fallopian tubes to evaluate occlusion or patency under direct visualization).
• Substantial Equivalence: A statement that the FTCM System is substantially equivalent to a previous system (Conceptus FTC System) based on "comparative performance testing" related to "force required to navigate the fallopian tube model" and further "performance testing and clinical data."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving the device meets them based on the provided text. The text mentions "comparative performance testing" and "clinical data" but gives no specifics about the acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for those tests.

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