(111 days)
The Interlace Medical Hysteroscopic Morcellation System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
The system consists of the following components: Control Unit, Morcellator Handpiece, Single Use Morcellator, Footswitch. The Interlace Medical Hysteroscopic Morcellation System will be used with standard hysteroscopes and fluid management systems.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Electrical safety and EMC standards met | Device meets electrical safety and EMC standards. |
| In-vitro performance equivalent to or better than predicate device | An in-vitro test "demonstrated that the device performs equivalent to or better than the predicate device." |
| Substantial equivalence in design, materials, construction, and intended use as predicate | Device is "substantially equivalent in design, materials, construction and intended use as that of the predicate." |
| No new safety and efficacy concerns compared to predicate | Device "does not raise any new safety and efficacy concerns when compared to the similar legally marketed device." |
| Capable of safely and accurately performing intended use | Device is "capable of safely and accurately performing the stated intended use." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "an in-vitro test" but does not specify the sample size (e.g., number of morcellations, amount of tissue removed, or number of devices tested).
- Data Provenance: The study was "in-vitro," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not explicitly stated, but given the sponsor is Interlace Medical Inc. located in Framingham, MA, USA, and the FDA review, it is highly probable the testing was conducted in the USA. It was a prospective test, as it was conducted to demonstrate device performance for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. As the study was an in-vitro performance test comparing the device to a predicate, it likely involved objective measurements based on engineering or laboratory protocols rather than human expert interpretation of results.
4. Adjudication method for the test set:
This information is not provided. Given the nature of the in-vitro performance test, it's unlikely a human adjudication method (like 2+1, 3+1) was used. Performance would have been measured against technical specifications or direct comparison to the predicate device's measured 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:
No. A MRMC comparative effectiveness study was not done. The device is a medical instrument (Hysteroscopic Morcellation System), not an AI-powered diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The "in-vitro test" mentioned in point 7 of the "Performance Testing" section can be considered a standalone performance evaluation of the device's mechanical function, without direct human-in-the-loop performance measurement for regulatory submission purposes. The device's operation is mechanical, and its performance was assessed in a controlled environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the in-vitro performance test would have been established by objective technical measurements and engineering specifications related to the device's ability to resect and remove tissue, compared directly against the performance of the predicate device under similar conditions. This is not comparable to ground truth derived from expert consensus, pathology, or outcomes data, which are typically used for diagnostic or screening devices.
8. The sample size for the training set:
Not applicable/Not provided. The Interlace Medical Hysteroscopic Morcellation System is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established:
Not applicable. As stated above, there is no training set for this device.
§ 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.