(61 days)
The IDC System is indicted to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
The Boston Scientific IDC System is manufactured from platinum and comes attached to an Interlocking Coil Pusher. It is designed to be delivered under fluoroscopy using a .018" compatible microcatheter with two radiopaque tip makers. The interlocking design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in precise, controlled delivery.
Here's an analysis of the provided text regarding the Interlocking Detachable Coil System (IDC System) and its acceptance criteria, focusing on the available information:
Based on the provided document, the device did not undergo a study with acceptance criteria measuring performance in the way a diagnostic AI device would. Instead, the focus was on substantial equivalence to predicate devices through functional and integrity bench testing and biocompatibility testing.
Here's the breakdown of the requested information, addressing what is present and what is not present in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional and Integrity Bench Testing: The device must demonstrate functional and structural integrity comparable to predicate devices. | Functional and integrity bench testing was performed, and the data supported the substantial equivalence of the IDC System to the predicate devices. (No specific numerical performance metrics are provided in the summary). The device is described as "manufactured from platinum and comes attached to an Interlocking Coil Pusher. It is designed to be delivered under fluoroscopy using a .018" compatible microcatheter with two radiopaque tip makers. The interlocking design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in precise, controlled delivery." This description implies functional success in a simulated environment, but specific quantifiable results are not given. |
| Biocompatibility Testing: The device must meet biocompatibility standards outlined in ODE Blue Book Memorandum #G95-1 / ISO-10993. | Biocompatibility testing to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" was performed, and the data supported the substantial equivalence of the IDC System to the predicate devices. (No specific numerical performance metrics are provided in the summary). |
| Substantial Equivalence: The device must demonstrate equivalence in indications for use and technical characteristics to legally marketed predicate devices. | The conclusion states: "Based on the Indictions for Use, technical characteristics testing the IDC System has been show to be substantially equivalent to the predicate device." The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." |
Important Note: This document pertains to a 510(k) Pre-Market Notification for a medical device (an arterial embolization coil), not for an AI diagnostic tool. Therefore, the "acceptance criteria" are related to safety, performance for its intended physical function, and substantial equivalence to existing devices, rather than AI performance metrics like sensitivity, specificity, or AUC.
2. Sample size 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 applicable / Not mentioned. The testing described (functional, integrity bench testing, and biocompatibility testing) does not typically involve a "test set" of clinical data or patient samples in the way an AI algorithm would. These are laboratory-based tests of the device itself.
- Data Provenance: Not applicable / Not mentioned. The tests are described as "bench testing" and "biocompatibility testing," which implies laboratory settings rather than clinical data from specific countries or patient populations.
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)
- Number of Experts: Not applicable / Not mentioned. Since this is not an AI diagnostic device, expert consensus on ground truth for a test set is not relevant. The "ground truth" for the bench and biocompatibility tests would be established by validated test methods and passing criteria for those specific physical and biological tests.
- Qualifications of Experts: Not applicable / Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / None. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in diagnostic studies. This document describes physical and biological testing of a medical device where objective pass/fail criteria are employed.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating the impact of AI on human reader performance, which is not relevant for this physical medical device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is not an algorithm. Its "performance" is its ability to be delivered, its interlocking mechanism, and its biocompatibility, which are inherent physical properties and functions.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the bench testing, the "ground truth" is adherence to engineering specifications, material science standards, and established physical performance criteria (e.g., tensile strength, deployment reliability, retraction capability). For biocompatibility, the "ground truth" is compliance with ISO-10993 standards and FDA guidance regarding biological safety. These are objective, definable criteria rather than subjective expert consensus on diagnostic findings or clinical outcomes.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not mentioned. This device does not use a "training set" in the context of machine learning. The design and manufacturing processes are iterative but do not involve training an algorithm on a dataset.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. There is no training set mentioned or implied for this device.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).