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The intended use of the Tripter-X1 Duet Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.

The provided document is a 510(k) premarket notification for a medical device called the "Tripter X-1 Compact Duet with Sonographic Localization Option." This document relates to a device for Extracorporeal Shock Wave Lithotripsy (ESWL), which is a non-invasive procedure used to break up kidney stones.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "No clinical tests were performed." Therefore, there are no specific acceptance criteria or reported device performance metrics in this document. The device is cleared via a "special 510(k)" because it is considered a minor modification that does not change the fundamental technology or reduce safety and effectiveness compared to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical tests or test sets were used for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical tests or test sets were used, so no ground truth establishment by experts was performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical tests or test sets were used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-based diagnostic tool, and no MRMC studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

Not applicable. No clinical tests were performed.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (lithotripter), not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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The intended use of the Tripter-X1 Compact Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

The Compact is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.

The provided document is a 510(k) summary for the Tripter X-1 Compact Extracorporeal Shock Wave Lithotripter with a Sonographic Localization Option. It explicitly states that no clinical tests were performed (Section 7, "Clinical Tests").

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from clinical or standalone studies are mentioned.
2. Sample size used for the test set and the data provenance: No test set data is mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
4. Adjudication method for the test set: No adjudication method is mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: No MRMC study was performed.
6. Standalone (algorithm only) performance: This device is a medical device (lithotripter), not an AI algorithm, so standalone performance in that context is not applicable. Even if it were, no performance studies were conducted.
7. Type of ground truth used: Not applicable as no studies were performed.
8. Sample size for the training set: Not applicable as no AI/algorithm training is mentioned for this device.
9. How the ground truth for the training set was established: Not applicable as no AI/algorithm training is mentioned.

The submission claims that "The Compact with the Sonographic Localization Option meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Tripter X-1 Compact." This implies that its acceptance criteria were met by demonstrating substantial equivalence to predicate devices without the need for new clinical performance studies.

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Fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means. The Shock Wave Generator can be operated in 4 modes: a) Bottom Reflector only. b) Top reflector only. c) Alternate mode (asynchronous). d) Simultaneous mode (synchronous).

Here's an analysis of the provided text regarding the device's acceptance criteria and study, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria such as "fragmentation rate of X% for stones of Y size" or "success rate of Z%". Instead, it relies on regulatory compliance and the device being a "minor modification" with "same fundamental scientific technology and intended use" as predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document explicitly states: "No clinical tests were performed." Therefore, there is no test set in the traditional sense of a clinical study involving human subjects or patient data.
• Data Provenance: Not applicable, as no clinical tests were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable, as no clinical tests were performed and thus no ground truth derived from expert review of patient data.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical tests were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "No clinical tests were performed."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done

• This question is not applicable to this device. The "Duet" is an Extracorporeal Shock Wave Lithotripter (ESWL), which is a physical medical device, not an AI algorithm or software. Its performance is related to mechanical and acoustic properties, not software-based analysis.

7. The Type of Ground Truth Used

• Not applicable in the context of clinical or AI-based performance. The "ground truth" for this submission appears to be compliance with engineering and electrical safety standards (as listed in Section 7 - Performance Testing) and the established safety and effectiveness profile of its predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device and not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This device is a physical medical device and not an AI algorithm.

Summary of the Device Submission's Approach:

This 510(k) submission for the Direx Systems Corporation Tripter X-1 Compact Duet is a "special 510(k)" submission. This type of submission is used for modifications to a manufacturer's own legally marketed device (the predicate device) where the modification does not affect the intended use or fundamental scientific technology, and does not raise new questions of safety or effectiveness.

Because it was deemed a "minor modification," the submission relied heavily on:

• Substantial equivalence to predicate devices: The core argument is that the Duet shares the "same fundamental scientific technology and intended use" as its own prior device (Tripter X-1 Compact) and other legally marketed ESWL devices.
• Compliance with recognized electrical and safety standards: Extensive testing against IEC and UL standards confirmed its safety from an engineering perspective.
• Lack of requirement for new clinical data: The FDA agreed that "No clinical tests were performed" were necessary because the modification ("enables the use of 2 reflectors instead of one") was not considered to introduce new risks or alter the fundamental mechanism of action that would necessitate new human trials.

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