(90 days)
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.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Safety: Minimal force applied to wire tip | Laboratory testing demonstrated that small forces are applied to the wire tip during clinical use. |
| Safety: Force to advance catheter | Laboratory testing demonstrated that the force required to advance the Stargate Catheter is no greater than the force required to advance the VS Catheter (predicate). |
| Safety: Kinking likelihood | Laboratory testing confirmed that the Stargate Catheter is less likely to kink as compared to the VS Catheter (predicate). |
| Safety: Tubal damage (preclinical) | A fallopian tube catheterization histology study in rabbits demonstrated "no significant difference in fallopian tube damage between the catheterized and control tubes." |
| Effectiveness: Improved diagnostic capability | Clinical testing: Participating clinicians reported that they were able to make a better diagnosis of tubal health with the Stargate Catheter as compared to the VS Catheter (predicate). |
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.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.