(217 days)
The Fertiloscopy Kit is intended to be used for transvaginal hydro-laparoscopy, dye-test, salpingoscopy, and hysteroscopy during one procedure. The device is indicated for use in the diagnosis of tubo-peritoneal infertility.
The Fertiloscopy Kit has the same general intended use and similar principles of operation and technological characteristics as a combination of Circon's cleared THL, Cook's cleared IBA Catheter, Imagyn's cleared MicroSpan, and Origin's cleared Blunt Tip Trocar.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Soprane S.A. Fertiloscopy Kit FH 1.29 / FTO 1.40:
The provided 510(k) summary is for a medical device (Fertiloscopy Kit), not an AI device. As such, many of the standard questions regarding AI device performance metrics (such as sensitivity, specificity, F1 score, effect size for human readers with AI assistance) and AI-specific ground truth details (like expert consensus, training set size) are not directly applicable or reported in this type of regulatory submission for a traditional medical device.
However, I can extract the information that is present and indicate where certain information is not provided.
Acceptance Criteria and Device Performance Study for Soprane S.A. Fertiloscopy Kit® FH 1.29 / FTO 1.40
This submission describes a traditional medical device, not an AI-powered device. Therefore, the acceptance criteria and performance study focus on safety, functionality, and clinical utility in comparison to existing predicate devices, rather than the statistical performance metrics typically associated with AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance |
|---|---|---|
| Safety | No new safety concerns compared to predicate devices. | Leak testing of the balloon during inflation performed. |
| Sterility | Materials are sterile following sterilization procedures. | Sterility testing of the materials following sterilization performed. |
| Functionality/Effectiveness | Perform transvaginal hydrolaparoscopy, dye-test, salpingoscopy, and hysteroscopy. | "Fertiloscopy was shown to provide a 'diagnostic sequence giving, in a one time procedure, a complete and informative status of the uterus, tubes, ovary, and peritoneum.'" |
| Intended Use | Indicated for diagnosis of tuboperitoneal infertility. | The clinical study supports the device's utility in providing diagnostic information for tuboperitoneal infertility. |
| Biocompatibility | (Not explicitly stated, but assumed to be acceptable based on predicate devices) | (No specific data reported in this summary) |
Notes on Acceptance Criteria:
- For traditional medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often substantial equivalence to legally marketed predicate devices. This means demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicates.
- The performance data provided supports this claim of substantial equivalence by showing the device performs its intended functions safely and effectively.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set/Clinical Study): 160 patients.
- Data Provenance: Not explicitly stated, but the company is based in France (Lyon, France). It is reasonable to infer the clinical study was likely conducted in Europe, possibly France, given the company's location, but this is not confirmed in the text. The study is prospective in nature, as it describes a clinical study where the Fertiloscopy device was used and evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Explanation: For a clinical study evaluating a diagnostic procedure like fertiloscopy, ground truth would typically be established by the clinicians (e.g., gynecologists, fertility specialists) performing and interpreting the procedure, potentially cross-referencing with other diagnostic methods or surgical findings. The summary does not detail the specific method of establishing "ground truth" or the number and qualifications of experts involved in the interpretation of the 160 patient cases.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Adjudication methods like 2+1 or 3+1 typically apply when assessing the agreement between multiple human readers and/or an AI system against a gold standard. This level of detail for interpreting the findings of a clinical procedure in a 510(k) summary is generally not included unless there's a specific, complex diagnostic endpoint being evaluated in a comparative manner.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this type of study was not done.
- Effect Size with/without AI: Not applicable, as this is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is not an AI device. The device itself is an instrument used by a clinician, so there is always a "human-in-the-loop."
7. The Type of Ground Truth Used
- Type of Ground Truth: The study's conclusion, "Fertiloscopy was shown to provide a 'diagnostic sequence giving, in a one time procedure, a complete and informative status of the uterus, tubes, ovary, and peritoneum,'" suggests that the ground truth for the "diagnostic sequence" was likely based on clinical assessment/findings obtained directly from the procedure itself. This would be interpreted by the attending clinicians/surgeons. It's possible historical patient outcomes or subsequent diagnostic results were used for correlation, but it's not explicitly stated.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This is a traditional medical device, not an AI device that requires a training set. The "training" for such a device would involve technical design and engineering iterations, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): Not applicable, as this is not an AI device.
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope 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 culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. 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.