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The ANT-X System is indicated for use in conjunction with fluoroscopy imaging in percutaneous nephrolithotomy (PCNL) procedures to aid in needle positioning and alignment process.

The ANT-X System is an automated needle positioning medical device that is used in conjunction with fluoroscopy to support percutaneous interventions (PCNL). There are 4 main components to the system - the ANT-X Device. ANT-X Controller Box. ANT- X Needle Holder, and ANT-X Software. It is intended to be used in an operating theatre equipped with standard surgical equipment which are generally found in operating rooms.

The ANT-X Device holds a sterile, disposable needle-guide kit, the ANT-X Needle Holder. The main bulk of ANT-X Device is made of biocompatible polyetheretherketone (PEEK) material. PEEK is preferred to build the robot because it is radiolucent and lightweight while being able to provide relatively high material strength. The Device has a fixed base made of three pairs of high stiffness parallel linkages allow millimetric planar needle adjustment. The targeted insertion point will act as a pivot point for the needle. The device will be mounted onto the operating table with a 6-DOF instrument holder (FISSO Articulated arm) such that it can be precisely oriented to the area of interest on the patient.

The ANT-X Controller Box powers the ANT-X Device and is the integrating point for the whole ANT-X System. Images from the C-arm fluoroscopy machine will be passed into the ANT-X Controller Box and then to the ANT-X Software, in real-time. The user will then use the ANT-X Software to command the ANT-X Device to commence needle alignment between the chosen insertion point on the skin surface, and the desired target point within the body. Validation of the puncture trajectory and the final needle insertion will be performed by the surgeon.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance data presented, aiming to demonstrate safety and effectiveness comparable to predicate and reference devices, and adherence to relevant standards. Specific numerical acceptance criteria are not explicitly listed in a "criteria" column, but rather the performance values obtained are reported and deemed to meet "specifications" or be "within acceptable limit."

Study Details

1. Sample Size and Data Provenance:
   • Test Set (Clinical Study): Total of 71 patients. 35 in the Ultrasound-guided (USG) group and 36 in the Robotic Assisted Fluoroscopy (RAFG) group.
   • Data Provenance: Japan (randomized, single-blind clinical trial). Prospective in nature.
2. Number of Experts and Qualifications for Ground Truth (Test Set):
   • The document implies that traditional clinical outcomes (stone-free rate at 3 months, complication rates) were the primary ground truth. While radiologists/clinicians are involved in the procedures and assessments, the "ground truth establishment" isn't described as an expert consensus reading of images purely for validation purposes like in an AI image analysis tool. It's more about objective clinical endpoints.
   • The study involved "fellowship-trained surgeons" for the animal study and clinicians/surgeons for the clinical trial.
3. Adjudication Method for Test Set:
   • Not explicitly described in terms of a multi-reader adjudication process for image interpretation (e.g., 2+1 or 3+1). The primary outcomes are clinical, based on objective measurements (e.g., KUB radiography, CT scans for SFR, Clavien-Dindo classification for complications) rather than subjective image reads requiring adjudication.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   • No, a formal MRMC study as typically understood for diagnostic AI (where human readers interpret images with and without AI assistance to measure improvement in diagnostic accuracy) was not performed.
   • The clinical study was a comparative effectiveness study between two different procedural guidance methods (AI-assisted fluoroscopy vs. ultrasound guidance). It showed the effects of the AI-assisted system on procedural outcomes (e.g., fewer punctures, shorter puncture time), indicating how human proceduralists (not image readers) improve when using the ANT-X System compared to ultrasound guidance.
   • Effect size of human reader improvement with AI vs. without AI assistance: Not applicable in the context of an MRMC study measuring diagnostic performance. However, for procedural efficiency, the study did show improvement with the ANT-X:
     • Mean number of needle punctures: 1.83 (RAFG) vs. 2.51 (USG), a reduction of 0.68 punctures (p=0.025).
     • Median needle puncture duration: 5.5 minutes (RAFG) vs. 8.0 minutes (USG), a reduction of 2.5 minutes (p=0.049).
5. Standalone Performance (Algorithm Only):
   • Yes, the "Bench Testing" section describes tests of the algorithm's performance in isolation or in a controlled environment, disconnected from live patient interaction where a human decision-maker is involved:
     • Software Tracking Accuracy (including marker detection)
     • Positional Repeatability (of the robot)
     • Bullseye Alignment Accuracy
     • Puncture Accuracy
   • Image Registration Error (0.01-0.45mm) and Alignment Accuracy (0.14-0.97mm) are specific quantitative measures of standalone performance.
6. Type of Ground Truth Used:
   • Bench Testing: Engineering measurements, possibly phantom-based. For example, "Puncture Accuracy" would likely be measured against a known target in a phantom. Image Registration Error and Alignment Accuracy are direct measurements against a reference.
   • Clinical Study: Clinical outcomes data (Stone-Free Rate, complication rates, procedural metrics like puncture time and number of punctures), which are objective and generally established by clinical follow-up and imaging.
7. Sample Size for Training Set:
   • Not specified in the provided text. The document focuses on the validation and testing of the device, not its development or training phase.
8. How Ground Truth for Training Set was Established:
   • Not specified. This information would typically be proprietary to the manufacturer's development process and is not usually detailed in a 510(k) summary, which focuses on validation data for marketing clearance.

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