(184 days)
The MAKO Device is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the proximal fallopian tube for cytological evaluation.
The MAKO Device is a hysteroscope accessory intended to collect cell samples from the proximal fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock.
The document describes the MAKO Device, a hysteroscope accessory for collecting cell samples from the proximal fallopian tube for cytological evaluation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for primary efficacy endpoints. Instead, it describes what was evaluated for safety and effectiveness in the clinical study. Based on the "Clinical testing" section, we can infer the following:
| Acceptance Criteria (Inferred from study objectives) | Reported Device Performance (from Clinical Testing) |
|---|---|
| Safety acceptable (e.g., low incidence of serious adverse events) | A single fallopian tube perforation noted in one subject, requiring no further medical intervention. Pre-existing proximal tubal occlusion was confirmed for this subject. |
| Device successfully navigates the fallopian tubes | 75 out of 80 fallopian tubes (93.75%) successfully navigated. |
| Device successfully collects adequate cell samples | Adequate samples collected in 71 out of 75 accessible tubes (94.67%). |
| Ability to obtain samples adequate for cytological evaluation | Assessed as part of "Ability to collect samples" and deemed successful in 71/75 accessible tubes. |
2. Sample Size Used for the Test Set and Data Provenance:
The clinical study served as the primary test set for demonstrating safety and effectiveness.
- Sample Size: 40 women (totaling 80 fallopian tubes, as each woman has two).
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "prospective, single-arm clinical study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical study's cytological evaluation. It only states the "ability to obtain samples that are adequate for cytological evaluation" was assessed. This usually implies evaluation by trained cytopathologists, but their number and specific experience are not provided.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No explicit mention of an MRMC comparative effectiveness study was made. The clinical study was a "single-arm" study, focusing on the device's performance in isolation rather than comparing it to human readers with or without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The MAKO Device is a physical medical device (hysteroscope accessory) that requires a human operator (physician) for its use. The concept of "standalone algorithm performance" typically applies to AI/software-as-a-medical-device (SaMD).
7. Type of Ground Truth Used:
For the clinical study, the ground truth for "adequate cell samples for cytology" would have been established by cytological evaluation performed by trained professionals (e.g., cytopathologists). The success of "navigating the fallopian tubes" would have been determined by the physician performing the procedure and potentially confirmed through visual inspection (hysteroscopic view) and the successful collection of a sample.
8. Sample Size for the Training Set:
The document does not describe a "training set" in the context of an algorithm or AI. The MAKO Device is a physical medical device. The "training" for such devices typically refers to the design, engineering, and iterative testing phases, not a data-driven training set for an AI model.
9. How Ground Truth for the Training Set Was Established:
As there is no AI training set mentioned, this question is not applicable. The device's design and functionality would have been validated through various engineering tests and simulations (bench testing) and then confirmed in human clinical trials.
§ 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.