(88 days)
The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
The MicroSpan-Gold Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.
The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided sterile for single use, and is made from both metal and plastic components.
The provided text describes a 510(k) submission for the Imagyn MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath. However, it does not include detailed information regarding acceptance criteria, specific performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment.
The "Performance Summary" section only states: "Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its electrical safety, thermal characteristics, and biocompatibility." This indicates that the proof of meeting acceptance criteria was based on bench testing (non-clinical) rather than a clinical study with human patients.
Therefore, many of the requested details cannot be extracted from the provided document.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Optical Characteristics | "demonstrate that the device performed according to its description" via non-clinical tests. (Specific metrics like resolution, field of view, illumination intensity are not provided.) |
| Mechanical Characteristics | "demonstrate that the device performed according to its description" via non-clinical tests. (Specific metrics like shaft diameter, bending strength, insertion force are not provided.) |
| Effect of Simulated Reuses | Evaluated via non-clinical tests to "demonstrate that the device performed according to its description." (Specific metrics on degradation over reuse cycles are not provided.) |
| Electrical Safety | Evaluated via non-clinical tests. (Specific standards met or results are not provided.) |
| Thermal Characteristics | Evaluated via non-clinical tests. (Specific temperature ranges or stability data are not provided.) |
| Biocompatibility | Evaluated via non-clinical tests. (Specific tests performed or results (e.g., cytotoxicity, sensitization) are not provided.) |
| Substantial Equivalence | The FDA determined the device is substantially equivalent to predicate devices (Imagyn MicroSpan Hysteroscope, Imagyn MicroLap-Gold Laparoscope, Optimed Technologies Rigid Fiber Optic Hysteroscope) for its stated intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The performance summary explicitly states "Non-clinical tests were performed." This implies bench testing of devices, not a test set of patient cases.
- Data Provenance: Not applicable, as no clinical patient data was used for performance evaluation in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical expert review or ground truth establishment for patient cases is mentioned, as the evaluation was non-clinical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process is mentioned.
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
- No. This device is a rigid fiberoptic hysteroscope and sheath, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" would be engineering specifications, established physical properties, and safety standards (e.g., ISO, ASTM standards for materials, electrical safety, optical performance). The document does not specify which exact standards were used.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning algorithm.
§ 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.