(84 days)
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.
For use in gynecological laparoscopy the following specific indications apply:
- Unexplained pelvic pain (acute, chronic)
- Infertility work-up
- Tubal sterilization
- Diagnosis and/or treatment of ectopic pregnancy
- Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)
- Evaluation of congenital anomalies of the pelvic organs
- Retrieval of foreign bodies
- Determination of the presence and extent of pelvic endometriosis
- Determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
- Access to abdomen for surgical procedures such as LAVH
- Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) organs
The Smith & Nephew Dyonics 2.7mm Microlaparoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design.
This 510(k) premarket notification for the Smith & Nephew Dyonics 2.7mm Microlaparoscope does not contain specific acceptance criteria or a study demonstrating that the device meets such criteria in the way you've outlined for performance studies (e.g., using AI, MRMC studies, sensitivity/specificity).
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. This is a common pathway for medical devices where the manufacturer shows that their new device is as safe and effective as a legally marketed device (the predicate).
Here's why your requested information isn't present in this document:
- Type of Device: The Dyonics 2.7mm Microlaparoscope is an optical instrument used for visualization and access during surgery, not a diagnostic algorithm or AI-powered device. Performance criteria for such devices typically revolve around optical quality, biocompatibility, sterilization efficacy, mechanical integrity, and safety. These are usually assessed through engineering tests, material testing, and sometimes simulated use or compatibility studies, rather than clinical studies with sensitivity/specificity metrics.
- Regulatory Pathway: The 510(k) pathway for substantial equivalence often relies on comparing the new device's technological characteristics and intended use to a predicate device that has already established its safety and effectiveness. This often doesn't require new clinical performance studies unless there are significant differences that raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer most of your detailed questions related to acceptance criteria, sample sizes, expert ground truth, or MRMC studies, as the provided document does not contain this type of information.
What the document does provide regarding "acceptance criteria" (implicitly equivalence):
The "acceptance criteria" in this context is the demonstration of substantial equivalence to the predicate device, the Richard Wolf Medical 2.0mm mini laparoscope, in terms of:
- Design
- Materials
- Function
- Intended Use
The "study" proving this is a comparison of technological characteristics between the Dyonics 2.7mm Microlaparoscope and the Richard Wolf Medical 2.0mm mini laparoscope.
Based on the provided document, here's what can be extracted, addressing your points where possible, and explaining why others are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Design Equivalence (to predicate) | "substantially equivalent in design" |
| Materials Equivalence (to predicate) | "substantially equivalent in materials" |
| Function Equivalence (to predicate) | "substantially equivalent in function" |
| Intended Use Equivalence (to predicate) | "substantially equivalent... and intended use" |
| Optical Functionality | "transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design." (Descriptive, not a performance metric) |
| General Laparoscopy Indications | Indicated for use in general laparoscopy to provide access, illumination, visualization, manipulation of body cavities, hollow organs, canals. |
| Gynecological Laparoscopy Indications | Indicated for specific gynecological procedures (e.g., unexplained pelvic pain, infertility work-up, tubal sterilization, etc.). |
2. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't present a test set in the context of a performance study to generate sensitivity/specificity. The "test" is the comparison against the predicate device's characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic performance (e.g., disease presence) is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) submission is the pre-existing regulatory clearance and established safety and effectiveness of the predicate device (Richard Wolf Medical 2.0mm mini laparoscope). The Dyonics Microlaparoscope is deemed safe and effective because it is substantially equivalent to this already approved device.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. 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 preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the 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.