Search Results

The Stone Grasping Basket is a medical device indicated for use by qualified surgeons in the treatment of salivary gland diseases. It is used endoscopically to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.

The stone grasping basket is a 30mm long, 4 wire, 10mm Nitinol Stone removal Basket, which is designed to pass through low diameter working channels of endoscopes for the purpose of retrieval of stones from the salivary gland.

The provided text describes a 510(k) premarket notification for the Sialo Modular Stone Grasping Basket, which is a medical device for removing stones from salivary glands. However, the document does not contain the detailed information necessary to complete the table and specific questions about acceptance criteria and a study proving device performance as requested.

Here's a breakdown of what is and is not in the document:

What is in the document:

• Device Description: A 30mm long, 4-wire, 10mm Nitinol Stone removal Basket designed for salivary gland stone removal.
• Intended Use/Indication for Use: Used endoscopically by qualified surgeons to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.
• Predicate Devices: Several previously approved stone baskets from Karl Storz Endoscopy, Millennium Devices Inc., and Cook Inc.
• Performance Standards: None mentioned.
• Test Data: "The Stone Grasping Basket device has been subjected to safety and performance testing before release. Testing of the device included various performance tests designed to ensure that the device meets all its functional specifications and complies with safety standards." This is a general statement, not a detailed report.
• Substantial Equivalence Conclusion: "The results of the performance tests demonstrate that the stone grasping basket meets its specifications for efficacy and exhibits similar physical properties as the predicate devices."

What is NOT in the document (and therefore cannot be provided in the answer):

• Specific acceptance criteria (numerical thresholds, success rates, etc.)
• Reported device performance against specific criteria.
• Details of the study that proves the device meets acceptance criteria.
• Sample size used for the test set or its provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Information about MRMC studies or effect sizes.
• Information about standalone (algorithm-only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set (as this is a mechanical device, not an AI/algorithm-based one, a "training set" in the machine learning sense is not applicable).
• How ground truth for the training set was established.

Based on the provided text, here is what can (and cannot) be answered:

1. A table of acceptance criteria and the reported device performance

(Note: The document only provides a high-level statement that the device meets "functional specifications" and "safety standards" and has "similar physical properties" to predicate devices. It does not list specific criteria or performance metrics.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not provided. The document states "The Stone Grasping Basket device has been subjected to safety and performance testing before release," but gives no details about the sample size, type of test specimens (e.g., artificial stones, animal models, clinical cases), or the provenance of any data.

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. This device is a mechanical tool for physical stone removal. The concept of "ground truth" established by experts in the context of diagnostic interpretation (like radiology) does not apply here. The "performance tests" would likely involve engineering tests on the device itself and potentially in vitro models.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Not provided. (See #3 explanation).

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 mechanical surgical instrument, not an AI or diagnostic imaging device. An MRMC study is not relevant to its type of performance assessment.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not clearly defined in the document. For a mechanical device, "ground truth" for performance would typically be based on objective physical measurements (e.g., basket diameter, wire tensile strength, grasping force), and observed success/failure in controlled in-vitro or benchtop tests using simulated stones or materials, rather than expert consensus on diagnostic images or pathology reports.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set" in that sense. The design and development process for such a device would involve iterative prototyping and testing, but not a "training set" as understood in AI/ML performance studies.

9. How the ground truth for the training set was established

• Not applicable. (See #8 explanation).

Ask a specific question about this device