(30 days)
The MyoSure XL Tissue Removal Device for Fluent in 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 XL Tissue Removal Device for Fluent is a sterile, single-use device that is 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 XL Tissue Removal Device for Fluent is designed to be used with a hysteroscope and to connect to the Fluent Fluid Management System. The MyoSure XL Tissue Removal Device for Fluent uses mechanical resection which allows the surgeon to have precise control over 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) premarket notification for the "MyoSure XL Tissue Removal Device for Fluent." This device is a Class II medical device intended for hysteroscopic resection and removal of intrauterine tissue such as submucous myomas, endometrial polyps, and retained products of conception.
The document focuses on demonstrating substantial equivalence to a predicate device (MyoSure Hysteroscopic Tissue Removal System and MyoSure Tissue Removal Devices, K172566). As such, the "acceptance criteria" discussed are primarily related to functional performance testing and biocompatibility to confirm that the modified device performs similarly to the predicate and meets established safety standards for medical devices.
Here's an analysis of the provided information based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner with specific numerical thresholds for performance metrics. Instead, it describes types of functional tests conducted to demonstrate equivalence to the predicate device. The performance is reported as meeting design specifications and being substantially equivalent to the predicate.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5:2009) | Complies with requirements |
| Sensitization (ISO 10993-10:2010) | Complies with requirements |
| Irritation (ISO 10993-10:2010) | Complies with requirements |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Complies with requirements |
| Functional Testing | |
| Connector Compatibility | Performance demonstrates substantial equivalence to predicate device. |
| Cutting Performance | Performance demonstrates substantial equivalence to predicate device. |
| Design verification (mechanical testing of handpiece) | Complies with design specifications; Performance demonstrates substantial equivalence to predicate device. |
| Reciprocation Rate Test | Performance demonstrates substantial equivalence to predicate device. |
| Risk Management (ISO 14971:2007) | Risks mitigated to an acceptable level. |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes (e.g., number of devices) used for the biocompatibility or functional performance tests. It also does not explicitly state the provenance (country of origin, retrospective/prospective) of any data used for these tests. Given that this is a 510(k) for a hardware device with minor modifications, the tests are typically benchtop (in vitro) and simulated use, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. For a 510(k) submission focused on minor device modifications and substantial equivalence through bench testing, ground truth is established by engineering specifications, validated test methods, and industry standards, rather than expert clinical interpretation of data.
4. Adjudication method for the test set:
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation of medical images or disease diagnosis, which is not the nature of the testing described here.
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:
This information is not applicable and not provided. The device is a surgical tissue removal device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The device is a physical, mechanical tissue removal instrument, not a standalone algorithm.
7. The type of ground truth used:
For biocompatibility testing, the "ground truth" is adherence to international standards like ISO 10993. For functional testing, the "ground truth" is the device's design specifications and the demonstrated performance of the predicate device. This is based on engineering specifications and validated test methods, not clinical "expert consensus, pathology, or outcomes data" in the typical sense of a diagnostic or therapeutic clinical trial.
8. The sample size for the training set:
This information is not applicable and not provided. There is no AI component mentioned, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided, as there is no training set mentioned.
§ 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.