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510(k) Data Aggregation
(95 days)
MYOSURE ROD LENS HYSTEROSCOPE
The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MyoSURE™ Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 184 mm long stainless steel tube containing a series of rod lenses and a 3.0 mm working channel. At the distal end of the tube, an "objective" lens captures the image of the "object". The series of "rod" lenses relays the image along the length of the tube. The image is directed by a 45° prism to an offset eyepiece that also contains "rod" lenses which relay the image along the length of the eyepiece tube. At the proximal end of the eyepiece, an "ocular" lens forms the image for the human eye and/or camera. The hysteroscope features a 0° angle of view and an 80° field of view.
The MyoSURE™ Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 3 mm working channel and a proximal seal. The 3 mm working channel is dimensionally compatible with the Interlace Medical Hysteroscopic Morcellator (K073690).
Additionally, the MyoSURE™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD x 283 mm length outflow channel which may be inserted through the hysteroscope's working channel. The outflow channel includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
The MyoSURE™ Rod Lens Hysteroscope is autoclavable and will be sold as a non-sterile, reusable device.
The provided text describes a 510(k) summary for the MyoSURE™ Rod Lens Hysteroscope. This is a traditional medical device submission, primarily focused on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies like those for AI/ML-based devices.
Therefore, many of the requested categories for AI/ML device evaluations are not applicable to this submission. The "performance testing" section refers to compliance with standards and validation protocols typical for mechanical/optical devices, not statistical performance metrics derived from large datasets.
Here's the breakdown of the information available in relation to your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Biocompatibility: Compliance with ISO 10993-1 for Biological Evaluation of Medical Devices. | The MyoSURE™ Rod Lens Hysteroscope "meets the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices." |
| Sterilization Efficacy: Ability to adequately sterilize the device. | "The ability to adequately sterilize the device is confirmed by validation protocol." |
| Electrical Safety/Performance (if applicable): Compliance with IEC 60601-2-18 (specific to endoscopes). | The MyoSURE™ Rod Lens Hysteroscope "complies with applicable portions of IEC 60601-2-18." |
| Functional Equivalence: Design, principles of operation, primary functional specifications, and materials of composition are equivalent to predicate devices (Henke Sass Wolf Hysteroscopes, Smith & Nephew Hysteroscope, Stryker Urology and Gynecology Hardware System). | The device is equivalent to predicates in: stainless steel fabrication, rod lens optical system, autoclavable and non-sterile reusable nature. Additionally, the MyoSURE and Smith & Nephew devices employ working channels compatible with tissue morcellator devices. |
| Intended Use Equivalence: Identical intended use to predicate devices and Interlace Medical Hysteroscopy System (K081070). | The intended use "is identical to that of both the Interlace Medical Hysteroscopy System (K081070) and the predicate Smith & Nephew Hysteroscope (K013870)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is a traditional medical device submission for a hysteroscope, not an AI/ML device relying on a "test set" of clinical data in the conventional sense. Performance was demonstrated through engineering testing and substantial equivalence.
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. There was no "test set" requiring expert-established ground truth for an AI/ML algorithm.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML device evaluation. The "ground truth" for this device's performance relies on engineering standards, material specifications, and functional demonstrations typical for medical instruments. For example, sterilization efficacy is validated against microbiological sterility standards, and biocompatibility against ISO 10993.
8. The sample size for the training set
- Not applicable. There is no AI/ML component or "training set."
9. How the ground truth for the training set was established
- Not applicable.
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