(21 days)
The Boston Scientific Lithotripter Compatible Basket is indicated for use in the retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi. The Lithotripter Compatible Basket should not be used for any purpose other than its intended application.
The Boston Scientific Lithotripter Compatible Basket is a stone retrieval and lithotripter compatible basket used for calculi crushing and biliary stone retrieval.
This document is a 510(k) summary for a medical device called the Trapezoid™ RX Lithotripter Compatible Basket. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.
Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, specific flexibility range) and corresponding reported device performance values are not explicitly stated. The document focuses on demonstrating "substantial equivalence" through comparison to a predicate device and general functional testing.
Instead of a table of specific criteria, the document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance characteristics, biocompatibility, and intended use. | "The results of design control activities do not raise any new issues of safety or effectiveness." |
| "The modified device is substantially equivalent to the currently marketed Boston Scientific Lithotripter Compatible Basket in terms of performance characteristics, biocompatibility, and intended use." | |
| "Functional testing" was conducted. | |
| Compliance with general controls and relevant regulations. | The FDA reviewed the 510(k) and determined the device is substantially equivalent. |
Explanation: The document emphasizes "substantial equivalence" as the primary "acceptance criterion" in the context of a 510(k) submission. This means the new device performs as safely and effectively as a legally marketed predicate device. The performance data section vaguely mentions "physical comparison and functional testing" which "support a determination of substantial equivalence," implying these tests confirmed the device's performance aligned with the predicate. However, detailed quantifiable results or specific acceptance thresholds are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). It generally refers to "functional testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the involvement of external experts to establish a "ground truth" for a test set. This type of device (a mechanical basket) does not typically utilize expert-reviewed imaging or diagnostic data in the same way an AI diagnostic tool would. The "ground truth" for this device would be its mechanical and functional performance, which is presumably evaluated through engineering tests rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set. As noted above, the evaluation seems to focus on engineering and functional testing rather than subjective human interpretation needing adjudication.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a mechanical surgical tool, not an AI diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical instrument, not an algorithm, so "standalone" algorithm performance is not a concept that applies here. The performance is inherently "human-in-the-loop" as it is operated by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is implied to be its functional performance and mechanical properties when compared to the predicate device. This would likely involve:
- Engineering specifications and measurements: Comparing dimensions, material properties, and mechanical characteristics against the predicate.
- Functional testing: Evaluating its ability to retrieve stones and perform lithotripsy in a simulated or benchtop environment, similar to how the predicate device performs.
- Biocompatibility testing: Ensuring the materials are safe for internal use.
It is not based on expert consensus on images, pathology, or clinical outcomes data in the way an AI diagnostic device would be.
8. The sample size for the training set
Not applicable. This device is a mechanical surgical instrument, not an AI model. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply to this device.
§ 876.4500 Mechanical lithotriptor.
(a)
Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.(b)
Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.