(65 days)
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.
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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.
| "Acceptance Criteria" (Implicit for 510(k) Equivalence) | Reported Device Performance (Retrieval Snare) |
|---|---|
| Intended Use Equivalence: | Indication for Use: "Retrieval of foreign body such as guidewires, pullwires, or plastic stents within the alimentary tract." (Matches predicate devices like "BSC's Retrieval Loop" for removal of foreign bodies, stones, PEG tubes, and stents). |
| Technological Characteristics Equivalence: | Catheter Usable Length: 180 cm (Similar to predicate devices ranging from 40-240 cm). |
| Sheath OD (mm): 1.9 or 2.3 (Identical to "BSC's Snare" and "BSC's Profile Polypectomy Snare," and similar to "BSC's Retrieval Loop" at 1.7 mm, suggesting comparable access). | |
| Handle Type: Plastic Three-Ring (Identical to all listed predicate devices). | |
| Loop Diameter: 11 - 33 mm (Identical to "BSC's Snare" and "BSC's Profile Polypectomy Snare," and comparable to "BSC's Retrieval Loop" at 3/8"). | |
| Loop Shapes: Oval, Crescent, or Hexagonal (Identical to "BSC's Snare" and "BSC's Profile Polypectomy Snare," broader than "BSC's Retrieval Loop" which is solely Oval, suggesting functional equivalence or minor enhancement within the same device type). | |
| Safety and Effectiveness: | Potential Complications: "Possible complications include, but may not be limited to: inadvertent perforation during retrieval." (This statement acknowledges known risks associated with such devices, implying that the device does not introduce new or unmanageable risks compared to predicate devices, or that these risks are acceptable given the intended use and benefits.) The 510(k) argues for safety and effectiveness through substantial equivalence, indicating that performance is expected to be similar to legally marketed devices with a known safety profile. |
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.
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.