Search Results

Ask a specific question about this device

The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.

2Fr, 8.3 mm Stone Dislodger Basket, Helical Design

This is a 510(k) summary for a medical device (a Stone Dislodger Basket) from 1997. The information provided in the summary is typical for submissions of that era, and focuses on substantial equivalence to predicate devices rather than clinical performance studies with specific acceptance criteria as would be expected for AI/ML-based medical devices or more recent submissions.

Therefore, many of the requested categories are not applicable or cannot be answered from the provided text.

Here's a breakdown of what can and cannot be derived from the provided text:

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

• Not Applicable / Not Provided. This document describes a new version of a physical medical device (stone dislodger basket) and not an AI/ML-based algorithm. The evaluation focuses on "Substantial Equivalence" to predicate devices, meaning it performs similarly and has similar safety and effectiveness profiles. There are no performance metrics or explicit acceptance criteria like sensitivity, specificity, or accuracy that would be associated with an AI/ML device.

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

• Not Applicable / Not Provided. This is a physical device, and the "testing" refers to product testing to demonstrate substantial equivalence, not a clinical study on a test set of data. The document mentions "Product Testing" and comparison to predicate devices, but doesn't specify sample sizes in a clinical sense or data provenance.

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. Ground truth and expert consensus are concepts typically applied to AI/ML device evaluation, not the kind of physical device described here.

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

• Not Applicable / Not Provided. See point 3.

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 / Not Provided. This device is a surgical instrument, not an AI assistance tool for human readers.

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

• Not Applicable / Not Provided. This is a physical device, not an algorithm.

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

• Not Applicable / Not Provided. See point 3.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no AI model or training set involved in this medical device submission.

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

• Not Applicable / Not Provided. There is no AI model or training set involved in this medical device submission.

In summary of what is available from the document:

The provided document describes a medical device (a Stone Dislodger Basket) and its submission for FDA 510(k) clearance in 1997. The primary "study" mentioned is "product testing" to demonstrate substantial equivalence to four predicate devices (K871777, K871779, K925495, K951309). The document states that "The results indicate that the proposed devices are 'Substantially Equivalent' to the predicate devices in terms of performance characteristics tested." This means the device met the implicit acceptance criterion of being as safe and effective as existing legally marketed devices. However, the specific details of these "performance characteristics tested" or the quantitative results are not provided in this summary.

Ask a specific question about this device

The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.

Not Found

The provided text is a 510(k) summary for a medical device called the "Retrieval Snare." This type of document is for premarket notification of a device claiming substantial equivalence to a predicate device, not typically a study designed to prove acceptance criteria for an AI/software as a medical device (SaMD). Therefore, much of the requested information (related to AI performance, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not contained within this document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "device performance" as presented in this regulatory submission by looking at the device's indications for use and comparisons to predicate devices. In the context of a 510(k), "acceptance criteria" relate to demonstrating substantial equivalence, and "device performance" is typically described through functional specifications and intended use.

Here's a breakdown based on the provided text, while acknowledging the inherent limitations for answering AI-specific questions:

1. Table of "Acceptance Criteria" and Reported Device Performance

In a 510(k), "acceptance criteria" aren't explicitly stated in the conventional sense of numerical thresholds for a specific study outcome (like sensitivity/specificity for an AI). Instead, the acceptance is based on demonstrating the device is substantially equivalent to a legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety/effectiveness. The table below attempts to translate the provided information into this framework.

Details of the "Study" (510(k) Submission):

The provided text is a 510(k) premarket notification. This is not a clinical study in the typical sense of testing a hypothesis with patient data. Instead, it's a regulatory submission used to demonstrate "substantial equivalence" to a predicate device. The "study" that proves the device meets the "acceptance criteria" (i.e., is substantially equivalent and safe/effective) is the comparison to legally marketed predicate devices.

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

• Sample Size for Test Set: Not applicable. This document does not describe a test set for performance evaluation in the context of an AI/SaMD. The "test set" here would implicitly be the specifications and characteristics of the device itself, compared against those of predicate devices.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No clinical data from patients is presented. The "data" used are primarily the specifications and regulatory history of the device and its predicate devices.

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

• Not applicable. Ground truth for an AI/SaMD test set is not relevant to a 510(k) submission for a physical medical device. Decisions within the 510(k) process are made by regulatory bodies based on documented evidence and comparisons.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Not applicable. There is no "test set" and no human adjudication process involved in comparing performance in the way described for AI/SaMD.

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 physical device, not an AI/SaMD. No MRMC study was performed or is relevant to this submission.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Not applicable. For a physical device 510(k), the "ground truth" for substantial equivalence is derived from established regulatory standards, predicate device characteristics, and the device's own specifications/testing (e.g., biocompatibility guidance, mechanical testing, etc., though details are not in this summary).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/SaMD; there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no "training set" and therefore no ground truth to establish for one.

In summary: The provided document is a regulatory filing for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a performance study for an AI/SaMD. Therefore, most of the questions related to AI/SaMD performance criteria, study design, and ground truth are not applicable.

Ask a specific question about this device

Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.

The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.

This document is a 510(k) summary for an endoscopic retrieval device from 1996. It does not contain the detailed information requested regarding acceptance criteria, device performance metrics, study design, expert qualifications, or ground truth establishment for a modern AI/ML-based medical device.

The document describes a traditional medical device (retrieval basket) and its intended use, contraindications, manufacturing overview, and sterilization methods. It references clinical use of retrieval baskets for over 20 years, implying established safety and effectiveness. However, it does not present any specific study data or acceptance criteria in the format requested for AI/ML performance evaluation.

Therefore, I cannot provide the requested table and study details based on the provided text. The information is not present in this 510(k) summary.

Ask a specific question about this device