(122 days)
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature,
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman venous Guidewires for Left Ventricular Lead Delivery. These two Boston Scientific Guidewires are hydrophilic coated steerable guidewires available in a 182.2 cm length. The distal tip is shapeable. For product specifications, including wire diameter, length, tip style and radiopaque tip length, please refer to the product label.
The provided text describes a 510(k) premarket notification for the ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires. This is a medical device submission, and the studies described are typically focused on demonstrating substantial equivalence to a predicate device rather than complex clinical performance trials with acceptance criteria for sensitivity, specificity, etc., as would be seen for AI/ML-based diagnostic devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (guidewires), acceptance criteria are typically specified as meeting performance benchmarks comparative to predicate devices. The text states:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from Study) |
|---|---|
| Tip flexibility (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| Device delivery support (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| Lead compatibility (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| Guidewire usage (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| No new safety or performance issues identified | No new safety or performance issues were identified during device testing. |
| Overall Substantial Equivalence to predicate devices | The device is considered substantially equivalent to the Boston Scientific ChoICE PTCA guidewire family (K964551) based on Indications for Use, technological characteristics, safety, and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The study described is bench testing. Therefore, the concept of "test set" and "data provenance" in the context of clinical data (e.g., country of origin, retrospective/prospective) is not directly applicable.
- Sample Size: The document does not specify the exact number of guidewires or samples tested for each bench test (tip flexibility, delivery support, lead compatibility, guidewire usage). It only states that "Bench testing was performed."
- Data Provenance: The data is generated from laboratory bench testing of the devices themselves, not from patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this type of device and study. Ground truth in this context is established through engineering and performance specifications and comparison to predicate devices, not by expert medical consensus.
4. Adjudication Method for the Test Set
This section is not applicable as there are no human readers or expert consensus involved in establishing the "ground truth" for the bench tests. Performance is measured against engineering specifications and predicate device characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to evaluate if AI assistance improves their diagnostic accuracy. The guidewire is a physical medical device, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This concept is relevant for AI/ML algorithms. The device described is a physical guidewire; it does not involve algorithms for its primary function.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering Specifications: Conformance to pre-defined physical and mechanical properties.
- Predicate Device Characteristics: Direct comparison of the new guidewires' performance and characteristics to those of the legally marketed predicate devices (Boston Scientific ChoICE PTCA guidewire family and Guidant HI-TORQUE Whisper View Guidewire). The primary goal is to show "substantial equivalence."
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical medical device like a guidewire. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
§ 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.