(274 days)
The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi.
The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi. Both devices operate just like the legacy (predicate) AUTOLITH® device. The units are softwarecontrolled, electronic devices capable of cracking calculi of virtually any size and composition. The devices are table-top units that connect to a disposable probe that is used in the working channel of an endoscope. A surgeon places the tip of the probe near the surface of the calculus/stone under endoscopic visualization. The physician then steps on a pneumatic foot pedal to activate the device. The electronic circuitry of the device generates a single high-voltage pulse or a series of pulses across the tip of the disposable flexible bipolar lithotripter probe. The discharge (in 0.9% normal physiological saline) produces sharp, high-amplitude hydraulic shockwaves that help to fragment the calculus/stone so it can be passed or removed without major surgery.
The provided text describes a 510(k) summary for the AUTOLITH® TOUCH / AUTOLITH® URO-TOUCH lithotripters, stating their substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.
This document is for a medical device (lithotripter) that is not an AI/ML device, but rather a hardware device with software controls and slight modifications from its predecessor. Therefore, the questions related to AI/ML specific studies (like sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The "Performance Data" section briefly mentions "Both Design Verification and Design Validation have been completed" and that "Non-clinical bench tests have been performed to prove substantial equivalence in the overall performance characteristics of the device."
Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations for AI/ML-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance acceptance criteria for a novel AI/ML algorithm. The core acceptance criterion for substantial equivalence in this context is that the new device produces the same pressure wave output as the current device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Production of the same pressure wave output as the predicate device | "Comparison testing was performed to prove that the output of the Autolith Touch is, in fact, the same as the output of the current device. These tests compared both the voltage waveform output applied to the probe as well as the actual pressure wave output from the probe that will be applied to the target stone." |
The design goal was to produce a modern, simpler, and more reliable version of the current device while ensuring it "produces the same pressure wave output as the current AUTOLITH® device."
"By design, the 6kV output capacitor is the main contributor in determining the voltage waveform applied to the probe. The new device incorporates the same 6kV output capacitor as the current device and uses modern circuitry to produce the same voltage waveform for the probe." |
| Biological Safety | Materials used are "not toxic and have been previously used to manufacture other medical devices." Tests include: Cytotoxicity, Sensitization (Kligman Maximization), Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity Test, Pyrogenicity, Latex, DEHP, all passing ISO 10993-1 requirements. |
| Electrical and Functional Safety | The device functions as intended with features such as regulating discharge voltage, displaying power and pulse count, automatically sensing probes, preset start-up values, prohibiting discharge without proper connection, and displaying when to replace probes. The "Modifications have no impact on the application or efficacy of the accessories." |
Study Details:
The study referenced is the "Comparison testing" mentioned in the "Substantial Equivalence" section. This was a non-clinical bench test.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the bench testing. The testing would likely involve multiple iterations or samples of the device and various probes to ensure consistent output.
- Data Provenance: Not applicable as it's a non-clinical bench test of physical output characteristics, not human or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a bench test comparing physical output characteristics (voltage waveform and pressure wave) to a predicate device. Ground truth is established by objective engineering measurements against the predicate device's known output, not expert human interpretation.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device. While the device has software controls, its performance is measured by its physical output as a lithotripter, not an AI algorithm's diagnostic or predictive capabilities.
7. The type of ground truth used
- Objective measurement against predicate device's output. The "ground truth" was the voltage waveform output and pressure wave output of the already cleared predicate AUTOLITH® device. The new system was designed to replicate this physical output.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device was engineered to replicate the predicate's performance.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”