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510(k) Data Aggregation
(88 days)
The ANCHORWIRE™ guidewires are intended for use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart. The device is not intended for use in the coronary arteries.
The Lake Region Anchorwire™ guidewires are comprised of a stainless steel core wire with a flexible, spiral shaped stainless steel coil on the distal end. The guidewire is offered in several lengths including 175cm, 203cm, and 230cm. The product is supplied sterile for single use only.
The provided text describes a 510(k) summary for the ANCHORWIRE™ Guidewires, focusing on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for a novel performance claim that would necessitate a detailed study proving it meets such criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not directly applicable or available in this document.
However, I can extract information related to the qualification testing performed to demonstrate equivalence.
Here's a breakdown of what can be inferred or explicitly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with specific numerical targets for performance metrics. Instead, it lists qualification tests performed to demonstrate equivalence to the predicate device. The "reported device performance" is implicitly that the device "meets established requirements" and is "as safe, as effective, and performs at least as safely and effectively as the legally marketed device."
| Qualification Test (Proxy for Acceptance Criteria) | Device Performance as Reported |
|---|---|
| Visual/Tactile Inspection | Acceptable |
| Dimensional Attributes | Acceptable |
| Mechanical Attributes | Acceptable |
| Kink Resistance | Acceptable |
| Device Compatibility | Acceptable |
| Pull Strength | Acceptable |
| Pouch Peel | Acceptable |
| Spiral Compression | Acceptable |
| Dye Penetration | Acceptable |
| Radiopacity | Acceptable |
| Fracture | Acceptable |
| Flex | Acceptable |
| Corrosion | Acceptable |
| Strength of Union | Acceptable |
| Body Stiffness | Acceptable |
| Particulate | Acceptable |
| Spiral Memory | Acceptable |
| Coil Free Play | Acceptable |
| Biocompatibility (Cytotoxicity, Kligman Maximization, Systemic Toxicity, Rabbit Pyrogen, Hemolysis, Complement Activation Assay, Thrombogenicity, Lee & White Coagulation, Unactivated Thromboplastin Time Assay, USP Physicochemical Test, Inhibition and Enhancement) | Acceptable (per ISO 10993 series) |
| GLP Animal Study (clinical safety and performance evaluation vs. predicate) | "as safe as effective and performs at least as safely and effectively as the legally marketed device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The animal study mentions "an animal study," but the number of animals or specific experimental design details are not provided.
- Data Provenance: The testing was performed by Lake Region Medical ("LRM performed testing"). This suggests it was internal testing. No country of origin for the data is specified beyond the manufacturer's location (Chaska, MN, USA). The studies appear to be prospective, as they were "performed to established requirements" as part of the submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document describes engineering and biological testing, not a study involving human interpretation of data where experts establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. This refers to the process of resolving disagreements among experts, which is not relevant to the described testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device, not an AI-powered diagnostic tool. The document describes a comparison to a predicate device, but not an MRMC study or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The non-clinical tests evaluate the device's physical and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, clinical outcome) is not directly applicable here. For the non-clinical tests, the "ground truth" would be the engineering specifications, industry standards (e.g., ISO 10993), and the defined characteristics of the predicate device against which equivalence is being assessed. For the animal study, the ground truth would be the direct observations of clinical safety and performance parameters in the animal model, compared to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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