(161 days)
The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Electro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi.
The Intracorporeal Electro-Mechanical Lithotriptor (EML) generator incorporates front panel controls that include a lighted main "Power Switch." An "Energy Switch" and "Rate Switch".
The provided text describes a 510(k) summary for the Nortech® Electro-Mechanical Lithotriptor (EML). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria for a novel device performance claim. Therefore, the information requested in your prompt (acceptance criteria, specific study design, sample size, expert ground truth, MRMC study, standalone performance, training set details) is not extensively provided in these documents, as it's not typically required for a 510(k) submission that relies on bench testing for substantial equivalence.
However, based on the text, I can extract the following information relevant to device performance and the "study" that proves it meets criteria for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Strictly speaking, the document doesn't define "acceptance criteria" in the way one might for a clinical trial's primary endpoint (e.g., "sensitivity > 90%"). Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to a predicate device. The performance is assessed through bench testing to show similar functionality and effectiveness in fragmenting calculi.
| Aspect | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Nortech® EML) |
|---|---|---|
| Primary Goal | Demonstrate substantial equivalence to a legally marketed predicate device (EMS Swiss Lithoclast) for the fragmentation of urinary calculi. | "The Northgate EML unit and EMS Swiss Lithoclast were compared during bench testing. The two (2) systems were similar in the way the calculi was fragmented." |
| "The performance data listed above, Comparison of Features, and detailed test data, indicate that the Northgate Technologies Inc. system is substantially equivalent to the EMS Swiss Lithoclast System." | ||
| Intended Use | Fragmentation of urinary calculi. | "The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Electro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi." |
| Method of Fragmentation | Similar mechanism to predicate device (mechanical impact on stone). | "Mechanical Impact" via a probe striking the stone. |
| Clinical Application | Requires use with a rigid or semi-rigid endoscope under direct vision for ureteral and bladder calculi (similar to predicate). | "Both units require using a rigid or semi-rigid endoscope under direct vision for ureteral and bladder calculi." |
| Materials | Non-toxic and previously used in other medical devices (similar to predicate if applicable for materials for 510k). | "All materials used to manufacture the Northgate Technologies Inc. EML generator, probe handle, and stainless steel probes (rods) are non-toxic and have been previously used to manufacture other medical devices." |
| Energy Settings | Provide controlled energy relevant to stone fragmentation (functional equivalence). | Low setting: ~40mJ; High setting: ~90mJ. |
| Rate Settings | Provide controlled pulse frequency relevant to stone fragmentation (functional equivalence). | Single pulse, 15 consecutive pulses (Low), 30 consecutive pulses (High). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a numerical sample size for "bench testing." It mentions a comparison of "the two (2) systems" (Nortech EML and EMS Swiss Lithoclast). This implies a qualitative and quantitative comparison of their performance on a set of calculi, but no specific count of stones or test runs is provided.
- Data Provenance: The data is from bench testing conducted by the manufacturer, Northgate Technologies Inc. The country of origin for the data is not explicitly stated but would presumably be the United States, where Northgate is located (Elgin, IL). The data is prospective in the sense that it was generated specifically for this submission to compare the two devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not indicate the involvement of experts to establish a "ground truth" for the bench tests in the sense of clinical interpretation. The "ground truth" for the bench testing would be the objective physical fragmentation of calculi, which can be measured and observed without expert clinical interpretation. The assessment of "similarity in the way the calculi was fragmented" would likely be based on objective observations and physical measurements rather than expert clinical consensus.
4. Adjudication method for the test set
Not applicable. There is no mention of a human-based adjudication process for the bench testing results described. The comparison was likely based on objective measurements and observations of stone fragmentation.
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
Not applicable. This is a medical device (lithotriptor) for physical stone fragmentation, not an AI or imaging diagnostic device that involves "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electro-mechanical lithotriptor, not an algorithm. Its operation inherently involves a human operator (physician) positioning the probe and activating it. The "standalone performance" referred to in the document is the EML unit's ability to fragment stones in bench tests, independent of a live patient, but still operated by a human.
7. The type of ground truth used
The "ground truth" for the bench testing was the objective physical fragmentation of urinary calculi. This would involve direct observation, measurement of fragment size, and potentially energy required for fragmentation. There is no mention of pathology, expert consensus (in the clinical interpretation sense), or outcomes data for this specific bench study.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment process.
§ 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.”