(22 days)
The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).
Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire. The distal core is made of Triton™ Nitinol alloy and has a coiled wire feature at the distal end. The proximal core is comprised of PTFE coated Stainless Steel material. The wire is available in .014" diameter and lengths ranging from 180 to 300 cm. The distal segment is coated with hydrophilic coating and is shapeable with a 3 cm radiopaque distal tip.
The provided document is a 510(k) Premarket Notification for the Heraeus TMW Guidewire, demonstrating its substantial equivalence to a predicate device. This document focuses on the physical and technological characteristics and performance testing of a medical device (guidewire), not an AI/ML-based medical device. Therefore, many of the requested criteria for an AI/ML device, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set sample size," or "ground truth establishment for training set," are not applicable or do not exist in this context.
However, I can extract information related to acceptance criteria, testing, and ground truth as it pertains to this physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that: "The Heraeus TMW Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device." However, a specific table detailing the exact numerical acceptance criteria and the corresponding reported performance values is not provided in this summary. It lists the types of tests conducted and implies that the results met the criteria and compared favorably to the predicate.
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | Sensitization | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | Intracutaneous Reactivity | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | Acute Systemic Toxicity | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | Pyrogen Testing | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | Hemolysis | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | Complement Activation | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Biocompatibility | In-Vivo Thrombogenicity | Compliance with ISO 10993-1:2009 & G95-1 | Met |
| Shelf Life | Not specified (implied) | Met | Met |
| Functional Specifications | Particulate testing | Not specified (implied) | Met |
| Functional Specifications | Corrosion resistance | Not specified (implied) | Met |
| Functional Specifications | Dimensional inspection | Not specified (implied) | Met |
| Functional Specifications | Sterilization | Not specified (implied) | Met |
| Functional Specifications | Sterile package integrity testing | Not specified (implied) | Met |
| Functional Specifications | Tensile strength | Not specified (implied) | Met |
| Functional Specifications | Tip stiffness | Equivalent to predicate device | Compared favorably |
| Functional Specifications | Torque response | Equivalent to predicate device | Compared favorably |
| Functional Specifications | Radiopacity | Not specified (implied) | Met |
| EO Sterilization Residuals | Compliance with ISO 10993-7 | Met | Met |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units tested) for each in vitro bench test. It generically states "bench tests were utilized."
- Data Provenance: The tests were "in vitro bench tests," meaning they were conducted in a laboratory setting, not on patient data. There is no information on country of origin of data, or whether it was retrospective or prospective, as these are concepts typically relevant to human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for a physical medical device like a guidewire is established through objective engineering and materials science principles and standards (e.g., ISO, ASTM). It does not involve human expert interpretation of images or clinical data in the same way an AI/ML diagnostic device would.
4. Adjudication method for the test set:
- This is not applicable. The performance of a physical device against engineering specifications does not typically involve an adjudication method by multiple human experts.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a guidewire, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI/ML algorithm. Its performance is inherent in its physical and mechanical properties.
7. The type of ground truth used:
- The "ground truth" for this device is based on established engineering specifications, material properties, and biocompatibility standards (e.g., ISO 10993-1, ISO 10993-7, "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995"). The device's performance is measured against these objective standards and compared to the predicate device's known characteristics.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
§ 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.