FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a marketing approval letter from the FDA for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, with a focus on a modification related to the resterilization of the Sirius Pintuition Probe. As such, the information provided primarily relates to demonstrating the substantial equivalence of the modified device to its predicate, rather than a full, de novo study proving the initial efficacy of the entire system.

Therefore, many of the requested data points (like sample size for test set, number of experts for ground truth, MRMC study, training set size, etc.) are not explicitly present in the provided text as this is a 510(k) "Special" submission, indicating a modification to an already cleared device. The focus is on verifying the impact of the modification (resterilization) on safety and performance, rather than re-proving the original device's effectiveness.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's overall performance (e.g., specific accuracy metrics). Instead, it focuses on demonstrating that the modification (resterilization) does not negatively impact the established safety and performance of the device.

The reported device performance is largely a qualitative statement of comparability to the predicate device due to the nature of a Special 510(k).

Acceptance Criteria (Implied for Modification)	Reported Device Performance
Probe Sterility (after resterilization)	Sterilization in STERRAD NX and NX100 systems is validated and implemented. The modification allows for sterilization, removing the mandatory sterile sheath requirement if sterilized.
Functional Compatibility (after resterilization)	Testing was conducted to evaluate "functional compatibility" of the modified device after resterilization. (Specific results are not detailed, but the conclusion of substantial equivalence implies satisfactory performance).
Overall Safety and Performance of the Sirius Pintuition Localization System (post-modification)	"The Sirius Pintuition Localization System has the same Intended Use as the predicate device (K200734). The device is identical, apart from the changes proposed related to (re)sterilization of the Probe in STERRAD NX and NX100 systems. These changes do not impact substantial equivalence..."
Biocompatibility (after resterilization, if applicable to new probe material/interaction)	Biocompatibility evaluation was conducted. (Assumed satisfactory, as no adverse findings are mentioned).
MR Safety Testing (after resterilization, if applicable to any new material or component interaction)	MR safety testing was conducted. (Assumed satisfactory).
Electrical Safety Testing (after resterilization, if applicable to any changes in electrical components/housing)	Electrical safety testing was conducted. (Assumed satisfactory).
Packaging Validation (for new or affected components)	Packaging validation was conducted. (Assumed satisfactory).
Shelf Life Validation (for new or affected components)	Shelf life validation was conducted. (Assumed satisfactory).
Design Verification	Design verification was conducted. (Assumed satisfactory).
System Accuracy and Range Verification	System accuracy and range verification was conducted. (Assumed satisfactory and unchanged from predicate).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided document. The testing involved "ADDITIONAL: Sterilization validation and functional compatibility testing" along with other elements like design verification, system accuracy/range verification, biocompatibility, MR safety, packaging, shelf life, and electrical safety. These tests would involve various samples of the device and its components, but specific numbers are not given.
Data Provenance: Not explicitly stated, though Sirius Medical Systems B.V. is based in the Netherlands. The tests are described as "pre-clinical testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/specified. This document describes pre-clinical validation studies relating to a device modification (resterilization), not a study evaluating human performance or diagnostic accuracy that would typically involve expert-established ground truth on a test set of clinical cases.

4. Adjudication Method for the Test Set

Not applicable/specified. This type of information is generally relevant for studies involving human interpretation or diagnostic decision-making using images or clinical data, where conflicting expert opinions might need to be resolved. This document pertains to validation of a physical device modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this particular submission. The submission is a "Special 510(k)" for a modification (resterilization of the probe) to an already cleared device. MRMC studies are typically used to evaluate the diagnostic accuracy of the entire system (algorithm + human reader) in clinical use, which would have been part of the original device's clearance or a new, significant indication. This document references a "Clinical Evaluation, including clinical safety and performance data with the actual device, a previous version of the device and an extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices," but this is not the same as an MRMC study on the effectiveness of AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Sirius Pintuition System is a localization system that relies on a physical probe and magnetic seed for non-imaging detection and localization, guided by a human user. There isn't an "algorithm-only" component in the sense of an AI-driven image analysis tool. The device provides "audible and visual cues (distance in mm)" to the user.

7. The Type of Ground Truth Used for the Test Set

The concept of "ground truth" in the context of this submission (a device modification for resterilization) is related to objective physical and biological parameters:

Sterility Validation: Absence of viable microorganisms after sterilization.
Functional Compatibility: The device operating within specified performance parameters (e.g., accuracy, range) after resterilization.
Biocompatibility: Absence of adverse biological reactions to the device materials.
Safety Standards: Compliance with electrical safety and MR safety standards.

These are established through laboratory testing and engineering verification, not typically through expert consensus, pathology, or outcomes data in the typical sense for diagnostic algorithms.

8. The Sample Size for the Training Set

Not applicable/specified. The Sirius Pintuition System is a magnetic localization device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of image or clinical data for model development. The system operates based on established physical principles of magnetism.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As mentioned above, there isn't a "training set" for this type of device. The system's functionality is based on physics and engineered specifications.

Summary

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.