(91 days)
The Transvaginal Endoscope (TVE) and Accessories are indicated for use to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, allow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures.
Specific Indications for Use
- Unexplained pelvic pain (acute, chronic) .
- . Menstrual abnormalities;
- Infertility and sterility; .
- Indefinite pelvic mass; .
- Ectopic pregnancy; ●
- . Pelvic endometriosis;
- Polycystic ovaries: .
- . Pelvic inflammatory disease (PID);
- . Pain mapping:
- Congenital abnormalities of the pelvic organs; .
- Lysis of adhesions: .
- Cytology mapping; .
- . Biopsy.
The TVE Set is indicated for use by qualified surgeons during outpatient or clinical endoscopic examination of the female genital tract. This examination method is designed to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, allow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures. Indications for use are:
- Unexplained pelvic pain (acute, chronic) .
- . Menstrual abnormalities;
- Infertility and sterility: .
- . Indefinite pelvic mass;
- Ectopic pregnancy; .
- Pelvic endometriosis; .
- Polycystic ovaries: .
- Pelvic inflammatory disease (PID); ●
- Pain mapping: ●
- . Congenital abnormalities of the pelvic organs:
- Lysis of adhesions; .
- Cytology mapping: .
- Biopsv. .
The Transvaginal Endoscope Set is comprised of a rigid, panoramic telescope, which utilizes rod lens technology, and several tubular stainless steel components. The body contact portions of the components are manufactured from surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text is a 510(k) summary for the Transvaginal Endoscope (TVE) Set. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based only on the provided input. This type of submission (510(k)) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results against specific acceptance criteria.
To answer your request, if this were a hypothetical scenario where detailed performance data was included in a 510(k) or premarket approval (PMA) submission, the information would typically be presented as follows:
(Hypothetical Example, as the provided text does NOT contain this information)
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical):
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Image Clarity | Resolution: ≥ 10 lp/mm (lines pairs per millimeter) | 12 lp/mm |
| Illumination Uniformity | Variation: ≤ 20% across field of view | 15% variation |
| Working Channel Diameter | ≥ 2.5 mm | 2.6 mm |
| Biocompatibility (Material) | Meets ISO 10993 standards | Compliant to ISO 10993-5 (cytotoxicity) |
| Leakage Current | ≤ 10 µA (microamperes) | 5 µA |
2. Sample Size and Data Provenance (Hypothetical):
- Test Set Sample Size: A clinical study involving 100 patients undergoing transvaginal endoscopy.
- Data Provenance: Prospective, multi-center study conducted in the USA, Germany, and Japan.
3. Number of Experts and Qualifications (Hypothetical):
- Number of Experts: 3 gynecologic surgeons and 2 reproductive endocrinologists.
- Qualifications: All had at least 8 years of experience in performing advanced endoscopic procedures, including transvaginal endoscopy.
4. Adjudication Method (Hypothetical):
- Images and procedural videos from the test set were independently reviewed by the 5 experts. For diagnostic accuracy assessments (e.g., identifying pelvic endometriosis), a "2+1" adjudication method was used: if at least two experts agreed on a finding, it was considered ground truth; if there was disagreement, a third independent expert (not involved in the initial two reviews) would adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical):
- Was it done? Yes, a prospective MRMC study was conducted to evaluate the diagnostic performance of the device in detecting specific pelvic pathologies compared to standard-of-care hysteroscopy.
- Effect Size: Not applicable for a device like an endoscope. MRMC studies are more common for AI-assisted diagnostic tools where the "improvement" is in human reader performance with AI. For an endoscope, the study would focus on its intrinsic performance characteristics and the diagnostic accuracy achievable using the device.
6. Standalone Performance (Hypothetical):
- Was it done? Not applicable for an endoscope as it is a visual diagnostic tool that requires human interpretation. Standalone performance refers to an algorithm's output without human intervention.
7. Type of Ground Truth Used (Hypothetical):
- Ground Truth: A combination of histopathology (for suspected lesions, biopsies taken during the procedure), surgical findings (if subsequent laparoscopy was performed), and consensus findings from the expert panel based on detailed pre-operative clinical workup, intra-operative visualization, and post-operative follow-up. For a device used to visualize, the "ground truth" often relates to the accuracy of the visual field provided relative to the actual anatomy.
8. Sample Size for the Training Set (Hypothetical):
- Not applicable as this is a medical device (endoscope), not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established (Hypothetical):
- Not applicable as this is a medical device (endoscope), not an AI algorithm.
In summary, the provided 510(k) documentation focuses on substantial equivalence, which means it claims the new device is as safe and effective as a legally marketed predicate device. It does not contain the detailed performance study information you requested.
§ 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.