(45 days)
The Lithotripter-Compatible Basket is indicated for 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.
Not Found
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It's a 510(k) premarket notification for a medical device (Lithotripter-Compatible Basket) seeking substantial equivalence to existing devices, not a clinical study report.
Here's a breakdown based on the information available and what is missing:
The document states: "Boston Scientific Corporation believes that Lithotripter-Compatible Basket is substantially equivalent to its currently-marketed Monolith Mechanical Lithotripter and Biliary Helical and Mini-Helical Baskets. ... Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Lithotripter-Compatible Basket will meet the minimum requirements that are considered acceptable for its intended use."
This indicates that substantial equivalence is the primary "acceptance criterion" in this context, rather than specific performance thresholds from a clinical trial. The "study" proving this is primarily the comparison to predicate devices and laboratory testing.
Here's an attempt to answer your questions based on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Monolith Mechanical Lithotripter & Biliary Helical/Mini-Helical Baskets) in: | Demonstrated through descriptive comparison (Figure 9-1) showing similarities in: |
| - Indications for Use (Biliary stone retrieval, crushing, removal) | - Matches (for retrieving, crushing, and removing biliary stones) |
| - Route of Admin (Endoscopic) | - Matches |
| - Basket Dimensions (5.5 x 2.5 cm; 4 x 2 cm; 3 x 1.5 cm) | - Matches Monolith; Different from Helical/Mini-Helical (22-37mm L, 8.5-20mm D) but still compatible for biliary stones |
| - Number of Wires (4) | - Matches Monolith; Different from Helical/Mini-Helical (3-5) |
| - Basket Shape (Octagonal) | - Matches Monolith; Different from Helical (Helical) |
| - Basket Material (Stainless Steel) | - Matches |
| - Sheath dimensions (O.D., I.D., Working Length) | - Not explicitly stated as matching in the snippet provided, but implied to be similar enough for substantial equivalence. The table is incomplete for sheath. |
| - Handle Mechanism (Three-Ring, Detachable) | - Different from Monolith (Trigger, Non-Detachable) and Helical (Three-Ring, Non-Detachable) but this difference is permissible as long as function is equivalent. |
| - Handle Injection Port (Present) | - Matches |
| Biocompatibility | - "Biocompatibility assessment was performed on the patient- and fluid-contact materials...with satisfactory results." |
| Safety and Performance (General) | - "Laboratory testing regarding characteristics was performed...to verify its safety and performance." |
| Packaging, Sterilization, Pyrogenicity | - Packaging in PVC tray, Tyvek-Mylar pouch. Sterilized by ethylene oxide gas (AAMI protocol). Pyrogenicity testing performed periodically. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not provided. The document describes laboratory testing and a comparison to predicate devices, not a clinical trial with a "test set" of patients.
- Data Provenance: Not applicable/Not provided. The data appears to be from internal laboratory testing and comparative analysis, not patient data from a specific country or study type (retrospective/prospective).
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)
- Not applicable/Not provided. No "test set" requiring ground truth establishment by experts is described in this regulatory submission for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No "test set" requiring adjudication is described.
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 a submission for a mechanical medical device (a lithotripter basket), not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. For substantial equivalence of a mechanical device, device specifications and performance data (e.g., tensile strength, flexibility, material composition, functional testing in a lab setting) are the "ground truth" for comparison against predicate devices, rather than clinical ground truth from patient data.
8. The sample size for the training set
- Not applicable/Not provided. No "training set" is described as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No "training set" is described.
§ 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.