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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 ERA Sheath is indicated for use during the resection and/or ablation of unwanted or diseased uterine tissue.

The ERA Sheath is a tubular sheath device incorporating an electrosurgical return electrode. The Sheath is designed to fit over the shaft of a standard gynecological resectoscope to act as an electrical return, thereby, obviating the need for an electrosurgical dispersive pad. The design of the Sheath enables a uterine tissue resection or ablation procedure to be performed in isotonic solution instead of hypotonic solutions which are currently used in these procedures, thereby eliminating the risk of hyponatremia.

The ERA Sheath is composed of four structural elements: 1) a non-conductive sheath material which is placed over a standard continuous flow resectoscope, 2) a return electrode located on the distal end of the sheath with a conductor that runs along the sheath's surface to the proximal end of the sheath, 3) a standard wire connector lead which is used to attach the sheath to the return/patient outlet on the electrosurgical generator, and 4) an insulating outer jacket which is configured to expose the distal electrodes.

The provided document describes a 510(k) summary for the "ERA Sheath," a medical device, but it lacks the detailed information typically found in a study report regarding acceptance criteria and performance data in the format requested. Specifically, it does not contain a discrete "study" proving acceptance criteria in the manner an AI algorithm study would and does not include the statistical metrics (e.g., accuracy, sensitivity, specificity, AUC) or study design elements (sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies) directly applicable to an AI device.

The document states:

• "Results from clinical evaluations, electrical safety testing, and histopathological evaluation of extirpated uterine tissue resected/abulated with the sheath were supplied in support of substantial equivalence."

This indicates that clinical data and safety testing were conducted, but the specifics of acceptance criteria and performance metrics used to demonstrate "substantial equivalence" to predicate devices, especially in a quantitative table format with specific performance values, are not present in the provided text.

Therefore, for your request, I must state that the information is not available within the provided document. The document is a 510(k) summary for a legacy medical device (a resectoscope sheath), not a study report for an AI-powered diagnostic device, which typically includes the detailed sections you've outlined.

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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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The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.

The Conceptus hysteroscope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user's eye or to a video camera.

This document is a summary of safety and effectiveness for a medical device (Conceptus Hysteroscope) submitted in accordance with SMDA 1990. It is a pre-market notification (510(k)) and not a study report detailing performance metrics against specific acceptance criteria.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.

A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, as stated in the document: "The intended use, optics, design, materials, specifications and mode of operation of the Conceptus Hysteroscope were found to be substantially equivalent to several predicate hysteroscopes."

To provide the information you requested, a different type of document, such as a clinical study report or a validation study report, would be necessary.

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