(23 days)
The Myosure Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
The modified Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate Myosure System: Myosure Control Unit, Myosure Tissue Removal Device, Myosure Foot Pedal. The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated and deactivated by the Myosure Foot Pedal. The Myosure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The morcellator's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the Myosure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The Myosure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.
The provided text describes the MyoSure LITE Tissue Removal Device and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way a clinical performance study for an AI/CADe device would.
The document is a 510(k) summary for a medical device which focuses on demonstrating substantial equivalence to a predicate device based on functional and performance specifications and biocompatibility, rather than clinical performance metrics like sensitivity or specificity.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states, "Verification/validation testing of the modified Myosure System was completed and confirmed that the modified Myosure System meets the same functional and performance specifications as the predicate Myosure System." However, it does not specify what those functional and performance specifications (acceptance criteria) are, nor does it quantify the reported device performance against them (e.g., specific thresholds or measurements). It only states they were met.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. This type of information is not relevant for the type of device and submission described. There is no "test set" in the context of clinical data for an AI/CADe device. The testing mentioned refers to engineering verification and validation.
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)
- Missing. Not applicable to this type of device and submission. There is no concept of "ground truth" established by experts for engineering verification and validation of a tissue removal device in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. 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
- Missing. Not applicable. This device is a surgical instrument, not an AI or CADe system for diagnostic imaging interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing. Not applicable.
8. The sample size for the training set
- Missing. Not applicable. The device does not involve a "training set" in the AI/machine learning sense.
9. How the ground truth for the training set was established
- Missing. Not applicable.
Summary of what the document does provide regarding "studies":
The "study" mentioned is "Verification/validation testing of the modified Myosure System," which is described as confirming that the modified system "meets the same functional and performance specifications as the predicate Myosure System." Additionally, it states that "The new patient contact materials... meet the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical devices." This indicates engineering and biocompatibility testing, not clinical performance studies with diagnostic metrics.
§ 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.