(190 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 MyoSURE Hysteroscopic Tissue Removal System consists of the following procedural components: 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 MyoSURE Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). 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 sidefacing 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™ Hysteroscopic Tissue Removal System and its comparison to a predicate device for 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study protocol for performance evaluation against these criteria, or information about sample sizes (beyond "in-vitro testing"), expert involvement, or adjudication methods in the way a typical AI/software device submission would.
This submission is for a physical medical device, not a software or AI-driven diagnostic device. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "training set" as they relate to AI performance metrics are not applicable in this context. The performance testing described focuses on safety, biocompatibility, and functional equivalence to a predicate device.
Here's an attempt to structure the available information based on your request, even though it doesn't fit neatly into an AI device framework:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a physical device and not an AI/software product, the "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) but rather as compliance with standards and equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety Standards Compliance | Meets electrical safety and EMC standards. |
| Biocompatibility Requirements | New patient contact materials meet ISO 10993-1. |
| Functional Equivalence to Predicate Device | In-vitro testing demonstrated performance equivalent to or better than the predicate Interlace Morcellator device. |
| Intended Use Equivalence | Intended use identical to the predicate Interlace Medical Hysteroscopic Morcellation System. |
| Technology and Method of Operation Equivalence | Demonstrated to be equivalent in technology, method of operation, functional performance, and intended use to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "in-vitro testing" but does not specify the sample size (e.g., number of devices tested, number of tissue samples processed).
- Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies with human or patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable. The "ground truth" for a physical device in this context would be its ability to safely and effectively resect tissue. This is evaluated through engineering testing (e.g., material properties, electrical safety, mechanical function) and functional in-vitro tests, not by expert consensus on diagnoses or images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations (e.g., reading images). This is not relevant for the type of testing described for this physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical tool, not a diagnostic imaging AI, and such a study would not be relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to established standards and the performance of the predicate device. For example:
- Electrical Safety: Standards like IEC 60601 (implied by "EMC standards").
- Biocompatibility: ISO 10993-1.
- Functional Performance: Direct comparison to the established performance of the predicate Interlace Morcellator in an in-vitro setting. This would likely involve measuring tissue resection rates, cutting efficiency, or other mechanical aspects.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth to be established for it.
§ 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.