(99 days)
Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.
The provided text describes a 510(k) premarket notification for the Interlace Medical Operative Hysteroscopy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not directly applicable or available in this document. The document specifically states that "The Interlace Medical Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device." and relies on "descriptive characteristics" to demonstrate substantial equivalence.
Here's a breakdown of why each specific point you asked for cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. There are no performance criteria established for this clearance, as it is based on substantial equivalence.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No dedicated "test set" or clinical study data is presented for performance evaluation in this 510(k) summary.
- 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): Not applicable. No ground truth establishment was conducted for a performance study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for a test set was described.
- 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 physical hysteroscopy system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical hysteroscopy system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for a performance study.
- The sample size for the training set: Not applicable. The device is not an AI/machine learning model needing a training set.
- How the ground truth for the training set was established: Not applicable. The device is not an AI/machine learning model.
Summary of Device Rationale based on the provided text:
The Interlace Medical Operative Hysteroscopy System received 510(k) clearance by demonstrating substantial equivalence to the predicate device, the Smith and Nephew Hysteroscope and Accessories (K013870). The equivalence is based on:
- Same Intended Use: "to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures."
- Similar Technological Characteristics: "The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same."
- No New Safety or Efficacy Concerns: The submission argues that due to the above similarities, the device "does not raise any new safety and efficacy concerns."
- Performance Testing: The only specific performance testing mentioned is that the system "meets electrical safety standards." This is a general safety requirement, not a clinical performance metric.
Therefore, the "study" that proves the device meets acceptance criteria in this context is the comparison to the legally marketed predicate device and the argument that no new safety or effectiveness questions are raised.
§ 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.