(52 days)
The MyoSure Tissue Removal System and Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:
Submucous myomas
Endometrial Polyps
Retained products of conception
The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the sponsor's previously cleared device:
- Tissue Removal Drive System
- Tissue Removal Device (TRD)
- Foot Pedal
The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps, submucous myomas, and retained products of conception hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue.
The provided text describes a 510(k) submission for a medical device called the Myosure Hysteroscopic Tissue Removal System. This submission is for a modification to an existing device, and therefore, the testing focuses on demonstrating equivalence to the predicate device, rather than establishing de novo performance criteria against a disease.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the modified device was tested against the predicate device to demonstrate equivalence in key performance areas.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent tissue cutting performance to predicate device | The modified Myosure System's tissue cutting performance is equivalent to that of the predicate device. |
| Equivalent cutter durability over time to predicate device | Cutter durability over time is equivalent for the modified and predicate Myosure Systems. |
| Equivalent heat generation over time to predicate device AND meets IEC 60601-1 thermal safety requirements | Heat generation over time is equivalent for the modified and predicate Myosure Systems and meets IEC 60601-1 thermal safety requirements. |
| Modified software/firmware meets functional and performance specifications of predicate device | 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. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions that "each device was tested for a 30 minute duration test interval" for tissue cutting, cutter durability, and heat generation. It does not specify the number of devices or repetitions within this test, nor the total "sample size" of beef tongue tissue used.
- Data Provenance: The testing was conducted by Hologic, Inc. (the manufacturer) as part of their 510(k) submission. The data is internal performance testing data. The source material for the testing (beef tongue) is not described by country of origin, and the tests are prospective bench tests, not retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a bench test demonstrating equivalence of an electromechanical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. As this is a bench test, there's no adjudication method for human interpretation. The "adjudication" is based on direct measurement and comparison to the predicate device's performance.
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 device is a surgical tool for tissue removal, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical hysteroscopic tissue removal system, not an algorithm. The "standalone" testing described is the bench performance testing of the device itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance testing was based on direct physical measurements and observations of the device's function, specifically:
- Tissue Cutting Performance: Likely measured by comparing the efficiency or effectiveness of cutting beef tongue tissue.
- Cutter Durability: Assessed by the device's ability to maintain cutting function over a specified duration (30 minutes).
- Heat Generation: Measured against the thermal safety requirements of IEC 60601-1.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for a training set.
§ 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.