(86 days)
The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.
The AMS Foreign Body Extractor is made of stainless steel and consists of an obturator, sheath, grasper, seals, handle, security clip, telescope stabilizers and ACMI adaptor ring. The AMS Foreign Body Extractor Accessory Kit contains replacement security clip, telescope stabilizers, ACMI adaptor ring, and seals. To facilitate insertion into the urethra and bladder, the obturator is placed inside the sheath. Once inside the bladder, the obturator is removed and the grasper is placed within the lumen of the sheath. The handle is then attached and the telescope inserted into the sheath. The grasping jaws are operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body.
The provided document, a 510(k) Premarket Notification for the AMS Foreign Body Extractor, describes the device and its intended use but does not contain detailed acceptance criteria or a comprehensive study demonstrating that the device meets specific performance criteria through clinical trials or extensive bench testing with quantifiable results.
The document states:
- "American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use."
- "All components are verified to ensure that only those meeting all parameters are released for sale."
However, it does not provide the specifics of these "descriptive data," "test plan," "test results," or the "parameters" used for verification. Therefore, I cannot construct a table of acceptance criteria and reported device performance, nor can I answer many of the subsequent questions based solely on the provided text.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance |
|---|---|
| Ability to grasp foreign bodies in the bladder | Not explicitly quantified in this document. |
| Ability to retract foreign bodies within a sheath | Not explicitly quantified in this document. |
| Ability to remove foreign bodies from the bladder | Not explicitly quantified in this document. |
| Operable under direct vision | Implied by "operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body" and "under direct vision." No specific performance metrics for this. |
| Biocompatibility of materials (stainless steel) | "The material has previously undergone biocompatibility testing." No specifics on acceptance criteria or results. |
| Component verified to meet parameters | "All components are verified to ensure that only those meeting all parameters are released for sale." No specifics on parameters or verification results. |
Regarding the study that proves the device meets the acceptance criteria:
The document describes "Bench Testing" but provides no details on the study design, sample sizes, or specific results. It only states: "American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use."
Here's a breakdown of the other requested information based on the provided text, highlighting what is unavailable:
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 specified.
- Data provenance: Not specified. It's likely bench testing conducted by American Medical Systems, Inc. in Minnetonka, MN, USA. However, whether "descriptive data" implies internal prospective testing or retrospective analysis is not stated.
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 specified. The testing described appears to be bench testing, not involving expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 device is a surgical instrument, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a manual surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For bench testing, "ground truth" would likely refer to engineering specifications and performance metrics (e.g., grasping force, retraction distance, material strength).
8. The sample size for the training set
- Not applicable. This is a direct-use medical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- 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.