(21 days)
The IQ™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ™ Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
The IQTM Guide Wires are silicone-coated, steerable, spring-coil guide wires available in a nominal diameter of 0.014 inches (0,36 mm) and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The tip will have Floppy flexibility, while the rail will offer Moderate Support (MS). The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The IQTM Guide Wires will be available with and without a lesion length marker system. The 185-centimeter version is designed with a proximal extension section that allows connection to the AddWireTM Extension Wire.
This document pertains to the 510(k) premarket notification for the IQ™ Guide Wire. The information provided describes the device, its intended use, technological characteristics, and a summary of non-clinical testing. However, it does not include the specific details needed to answer the questions about acceptance criteria and a study proving those criteria are met for a device that uses AI/algorithm. This is a traditional medical device, a guide wire, and its performance is evaluated through standard physical and mechanical tests, not AI model performance metrics.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, how training ground truth was established) are not applicable to this type of device and the information provided in the 510(k) summary.
Here's an attempt to answer the questions based on the available information, noting the aspects that are not applicable for this device:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement about the tests conducted and their outcome rather than specific, quantified acceptance criteria and performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Torque response satisfactory | Met minimum requirements |
| Tip prolapse satisfactory | Met minimum requirements |
| Tip shapeability satisfactory | Met minimum requirements |
| Radiopacity satisfactory | Met minimum requirements |
| Marker location accurate | Met minimum requirements |
| Lubricity satisfactory | Met minimum requirements |
| Coating adherence/presence satisfactory | Met minimum requirements |
| Tensile and shear strength satisfactory | Met minimum requirements |
| Combined load handling satisfactory | Met minimum requirements |
| Visual inspection satisfactory | Met minimum requirements |
| Device compatibility satisfactory | Met minimum requirements |
| Biocompatibility satisfactory | Met minimum requirements |
| Product shelf-life adequate | Met minimum requirements |
Study Proving Acceptance Criteria Met:
The document states: "Testing and evaluation of the IQ™ Guide Wires included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence/presence, tensile and shear, combined load, visual inspection, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ™ Guide Wires met all of the minimum requirements and are adequate for their intended use." This indicates non-clinical in vitro testing was performed.
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 for Test Set: Not specified. Standard practice for physical and mechanical tests of this nature would involve testing a statistically representative sample from multiple manufacturing lots, but the specific numbers are not disclosed in this summary.
- Data Provenance: Not applicable in the context of typical AI data provenance. The tests are in vitro physical and mechanical evaluations, likely performed in the manufacturer's R&D or testing facilities (Boston Scientific Corporation, Maple Grove, MN, USA).
- Retrospective or Prospective: Not applicable for in vitro physical testing.
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. Ground truth as typically defined for AI models (e.g., expert interpretation of medical images) is not relevant for in vitro physical and mechanical testing of a guide wire. The "ground truth" for these tests would be the established engineering standards and specifications for device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, which is not relevant for in vitro physical testing. The test results would be quantitative measurements against predefined specifications.
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 medical device (guide wire), not an AI-assisted diagnostic or prognostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This involves a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the AI context. For the in vitro testing, the "ground truth" would be established engineering specifications, industry standards (e.g., ISO, ASTM), and internal Boston Scientific quality requirements.
8. The sample size for the training set
Not applicable. This device does not involve an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI algorithm or a training set.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.