(471 days)
The Amplatz "GOOSE NECK" Microsnare is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system and hollow viscus. This includes intravascular foreign objects such as coils, balloons, portions of catheter and/or guidewires misplaced during interventional radiological procedures within the peripheral, neuro and cardiovasculature.
The Amplatz Goose Neck MicroSnare (NEUROSnare) is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the cornary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
The Amplatz "GOOSE NECK" Microsnare is a percutaneous retrieval and manipulation device with a uniquely shaped retriever loop. The "GOOSE NECK" Microsnare component consists of a core wire, with the "beak-like" retriever loop mounted at a right angle to the axis of shaft at its distal tip. The device is primarily comprised of a nickel-titanium alloy allowing virtual kink-resistant performance during navigation and retrieval of a foreign object.
The provided text describes a 510(k) summary for the Amplatz "GOOSE NECK" Microsnare, intended for retrieving foreign bodies from the cardiovascular system and hollow viscus. However, the document does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth methodologies typically found in a clinical study report for proving device performance.
The text states:
- "The Amplatz "GOOSE NECK" Microsnare has successfully passed all functional and safety testing requirements."
- "The Amplatz "GOOSE NECK" Microsnare is deemed substantially equivalent to commercially available MICROVENA and Target Therapeutics Retrieval devices based on functional testing and published clinical experiences."
This indicates that the device's performance was evaluated, but the specifics of how it met acceptance criteria for a study are not provided. The 510(k) summary is generally a high-level overview for regulatory submission, not a detailed clinical study report.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional testing requirements met | Successfully passed all functional and safety testing requirements. |
| Safety testing requirements met | Successfully passed all functional and safety testing requirements. |
| Substantial equivalence to predicate devices | Deemed substantially equivalent to commercially available MICROVENA and Target Therapeutics Retrieval devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "functional and safety testing requirements" and "published clinical experiences" but does not provide a sample size for any specific clinical or non-clinical test set.
- Data Provenance: Not specified. The data provenance (e.g., country of origin, retrospective/prospective) for the "functional and safety testing" or "published clinical experiences" is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The filing refers to "functional testing and published clinical experiences," but details on expert involvement in establishing ground truth are absent.
4. Adjudication method for the test set
- This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. An MRMC comparative effectiveness study is not mentioned. The regulatory submission is based on "functional testing and published clinical experiences" and establishing substantial equivalence to predicate devices, not on a direct comparison of human readers with and without AI assistance (which is not applicable here as it's a device, not an AI).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the Amplatz "GOOSE NECK" Microsnare is a physical medical device, not an algorithm or AI. Its performance is inherent to the device's mechanical function, not an algorithm. The term "standalone" in this context typically refers to the performance of an AI model independently.
7. The type of ground truth used
- The document implies that the ground truth for performance was established through:
- Functional and Safety Testing: Likely determined by successful completion of engineering specifications, mechanical tests (e.g., kink resistance, retrieval force), and biocompatibility assessments, rather than clinical 'ground truth' in the sense of pathology or expert consensus on clinical findings.
- Published Clinical Experiences: This suggests that existing literature or previous clinical use of similar devices informed the understanding of desired performance, but specific ground truth definition for a study is not given.
8. The sample size for the training set
- Not applicable/Not provided. As a physical medical device, there isn't a "training set" in the context of machine learning or AI. If "training set" refers to pre-market testing (e.g., bench testing, animal studies), the sample size for such activities is not detailed in this summary.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there's no training set in the AI sense, this question doesn't apply. For the general device development, ground truth would be established through engineering specifications, successful mechanical performance benchmarks, and compliance with safety standards. Details of these are not provided.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).