(88 days)
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location.
This 510(k) is being is being submitted to implement 5G and WiFi capability to the previously cleared Maestro System (K242323). This modification is intended for data offload; only Telemetry and Event logs will be sent over 5G or WiFi. A PCCP is also implemented for the ScoPilot feature.
Here's a summary of the acceptance criteria and the study details for the Maestro System, based on the provided FDA 510(k) clearance letter. It's important to note that the document is focused on a modification to an already cleared device and a Predetermined Change Control Plan (PCCP), so some of the detailed information often found in initial submissions might be less explicit here.
Acceptance Criteria and Reported Device Performance
The document describes various performance tests without explicitly listing pass/fail acceptance criteria values. However, it indicates compliance with recognized standards and that validation activities were performed to pre-defined performance requirements for the ScoPilot feature. For the purpose of this summary, I'll extract the performance aspects mentioned.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1:2005+A1+A2 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014+A1, AIM 7351731 Rev. 3.00: 20201 (wireless immunity), and IEEE/ANSI C63.27:2021 (wireless coexistence) |
| Software Verification & Validation | Documentation provided according to FDA guidance; included testing of ScoPilot feature, detection/tracking of instrument tips, motion trajectories, safety limits, malformed inputs at video/frame level. |
| ML Model Performance (ScoPilot) | Model performance (lower bound of 95%CI for AP and AR) demonstrated compliance with specifications on an independent test dataset, including brands unseen during training/tuning. |
| Payload Capacity | Tested to 4.4 lbs. |
| Malformed Input | Tested. |
| Force Accuracy | Tested. |
| Emergency Stop | Tested. |
| Hold Position Accuracy | Tested. |
| IFU Inspection | Tested. |
| Positioning Guidance & Collision Detection | Tested. |
| System Positioning Accuracy | Tested. |
| Bedside Joint Control Accuracy | Tested. |
| End to End Workflow | Tested. |
| Design Inspection | Tested. |
| System Setup | Tested. |
| System Latency | Tested. |
| Electro-Cautery Compatibility | Tested. |
| System Endurance | Tested. |
| Cybersecurity | Tested. |
| System Data Logging | Tested. |
| System Connectivity | Tested. |
| System Cloud Data | Tested. |
| OS Performance | Tested (related to OS update). |
| ScoPilot Motion Performance | Tested. |
| ScoPilot Vision Performance | Tested. |
Study Details
The primary study mentioned in this document relates to the validation of the ScoPilot ML model and the non-clinical bench studies for the overall system.
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Sample size used for the test set and the data provenance:
- ML Model Validation (ScoPilot): An "independent testing dataset containing videos" was used. The specific number of videos or cases is not provided in this document.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions using data "including brands unseen during training/tuning."
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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 for the ScoPilot ML model validation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- A MRMC study or any study comparing human readers with and without AI assistance is not mentioned in this document. The device (Maestro System) is an instrument holder and positioner, and the ScoPilot feature assists in instrument tracking and positioning, not in diagnostic interpretation where MRMC studies are common.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance testing for the ScoPilot ML model was done in a standalone manner, with the model being "trained and tuned" and then verified against "predefined performance requirements" on an "independent testing dataset." The performance metrics used were "lower bound of the 95%CI for AP and AR (Average Precision and Average Recall likely)."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the ScoPilot ML model, the ground truth establishment method is not explicitly detailed. It would likely involve manual annotation of instrument tips and surgical tools within the video frames by qualified personnel to create the labels against which the algorithm's detection and tracking are evaluated.
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The sample size for the training set:
- This information is not provided in the document. The text mentions the ML model was "trained and tuned through a K-fold cross-tuning process."
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How the ground truth for the training set was established:
- This information is not explicitly detailed in the document, but it would align with the method used for the test set (likely manual annotation of surgical tools in video data). The PCCP mentions "Modification retraining the ML model with the addition of newly acquired data enables it to detect surgical instrument classes already claimed, and an increased variety of other brands in the video feed more accurately" and adding "surgical cautery hooks to the ML model class hooks as another surgical instrument class." This implies a process of labeling or annotating new data for these specific elements.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.