(351 days)
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.
The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target. The needle sensor consists of a sensor head, cable and a connector.
Here's an analysis of the acceptance criteria and study information for the SonixGPS™ Needle Sensor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Accuracy | Equivalent performance to the predicate device (K092619) | The SonixGPS™ 0.9mm Needle Sensor and 0.55mm Needle Sensor demonstrated equivalent performance to the predicate device, which met the defined criteria. |
| Electrical Safety | Compliance with EN 60601-1 (2nd Edition, 1988) | The SonixGPS™ Needle Sensor met the acceptance criteria. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (2.1 Edition; 2001+A1:2004) | The SonixGPS™ Needle Sensor met the acceptance criteria. |
| Biocompatibility | Compliance with ISO 10993-1:2009 | The SonixGPS™ Needle Sensor met the biocompatibility requirements. |
Explanation of Implied Acceptance Criteria for System Accuracy:
The document states, "The subject devices met the same defined accuracy criteria as the predicate device," and "[The SonixGPS™] demonstrated equivalent performance which met the defined criteria." While the specific numerical accuracy criteria for the predicate are not detailed in this 510(k) summary, the core acceptance criterion for the SonixGPS™ Needle Sensor was to achieve performance equivalent to the predicate device (K092619) under its established accuracy protocol.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of tests, number of measurements, number of devices tested) for the performance "System Accuracy" testing. It only mentions that the "performance test used the same ultrasound system and setup to perform the accuracy test for SonixGPS™ 0.9mm Needle Sensor, SonixGPS™ 0.55mm Needle Sensor and the predicate device."
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "System Accuracy" test appears to be a technical or engineering performance test against a defined protocol, rather than a clinical study requiring expert interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable as the "System Accuracy" test described is a technical performance assessment, not a study involving human readers or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study described is a technical performance test comparing the new device against a predicate device's existing performance standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This document describes a standalone performance test of the device itself (the needle sensor), not an algorithm. The accuracy test described is for the device's ability to track position, which is an inherent function of the device, not an "algorithm only" performance separate from its intended use. While it's a "device only" test, the term "standalone" as typically used in AI/software refers to algorithmic performance without human intervention, which isn't directly applicable here as it's a physical device.
7. The Type of Ground Truth Used
For the "System Accuracy" test, the ground truth would be established by the needle sensor accuracy performance protocol and the Sonix 3D Motion Tracking (SonixGPS™) Verification Protocol and Report. This implies a defined, objective standard or known positions against which the device's tracking accuracy was measured. It's a technical ground truth rather than a clinical ground truth like pathology or expert consensus.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The SonixGPS™ Needle Sensor is an electromagnetic tracking hardware device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for this type of device.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.