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510(k) Data Aggregation
(123 days)
The Sentimag Magnetic Localization System when used with the Magseed® marker is indicated to assist in localizing soft tissue lesions.
The Endomag Sentimag System is the only non-imaging guidance system intended for use with the Magsed® magnetic marker.
The Sentimag Gen 3 System is the 3d generation of Sentimag detector, intended for the nonimaging detection and localization of Magseed® magnetic marker that has been implanted in a lumpectomy site intended for surgical removal. It consists of a base unit and a probe.
This generation of the device has two modes:
- a) Counts Mode: This mode is the exact equivalent of the current generation of the Sentimag detector (Sentimag Gen 2 - described in K153044). In this mode Magseed (K173587) and is detectable based on a counts signal displayed on the base unit of Sentimag device.
- b) Measure Mode: Please note that this mode has a different graphic display and is currently dormant in Sentimag Gen 3
The Sentimag Gen 3 System comprises of a mains-powered base unit, a detachable hand-held probe available in 2 sizes (Standard Probe and Thinner Probe) that is connected to the base unit with a flexible cable, and a detachable electronic footswitch that is connected to the base unit with a flexible cable. A single use sterile sheath is required to be placed over the probe prior to the procedure, this is to be supplied by the hospital.
The hand-held probe which emits an alternating magnetic field that detects the magnetic response of the marker. When the marker is exposed to a magnetic field it becomes magnetic, and this magnetism can then be detected using the probe which gives an audible and visual signal of the level of magnetism. In count mode this is in the format of a numerical reading.
Acceptance Criteria and Device Performance Study for Sentimag System (K222832)
Based on the provided document, the Sentimag System (Gen 3) is a magnetic localization system intended to assist in localizing soft tissue lesions when used with the Magseed® marker. The submission describes the device's substantial equivalence to previous generations, particularly regarding its "Counts Mode." The "Measure Mode" is currently dormant and subject to specific risk control measures to prevent its use.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal table of "acceptance criteria" with numerical targets for clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the Sentimag System (Gen 3) itself. Instead, the performance studies primarily focus on demonstrating substantial equivalence to its predicate device (Sentimag Gen 2) in its "Counts Mode" and verifying basic functional performance.
The key acceptance criterion, though implicitly, is that the Sentimag Gen 3 in Counts mode performs equivalently to the Sentimag Gen 2 in detecting the Magseed® marker.
| Acceptance Criteria (Implicit) | Reported Device Performance (Sentimag Gen 3 - Counts Mode) |
|---|---|
| Equivalent Sensitivity to Sentimag Gen 2 in detecting Magseed® | Sentimag (Gen 3) had equivalent sensitivity to Sentimag (Gen 2) in counts mode. |
| Equivalent Functional Performance with Standard and Thin Probes | Functional performance of both standard and thin probes is equivalent in both Gen 3 modes (and in Counts mode, equivalent to Sentimag Gen 2 predicate). |
| Detectable signal with Magseed® in various simulated tissues | Simluated Use of Sentimag (Gen 3) with Magseed (K173587) in Counts mode showed detection in Liver, Thyroid (CIRS Model 074), Breast (CIRS Model 073), Abdominal Tissue Plate (SynDaver 141720, 2N Std, 5mm Fat, 5mm muscle), and Lung Model (SynDaver). |
| Visual and audible signal generation | Provides a visual and audible signal of the level of magnetism, similar to the predicate device. |
| Risk control measures for dormant Measure Mode are effective | Specific risk control measures (disabling the mode, distinct display, training, IFU directions) are in place to prevent wrong use. |
2. Sample Size and Data Provenance for Test Set
The reported studies are pre-clinical/laboratory testing, not human clinical trials with specific test sets of patients. Therefore, information on sample size for a "test set" in the traditional clinical sense, country of origin, or retrospective/prospective nature of patient data is not applicable or provided.
The "test set" in this context refers to the simulated tissues and the devices themselves. The document mentions:
- Usability testing: of Sentimag (Gen 3) - Standard and thin probe. (Number of users/tests not specified).
- Sensitivity testing: of Sentimag (Gen 3) standard and thin probes against Magseed (K173587). (Number of tests not specified).
- Comparison of Sentimag (Gen 3) and Sentimag (Gen 2) sensitivity: in counts mode. (Number of comparisons not specified).
- Simulated Use: Using various simulated tissues (Liver, Thyroid, Breast, Abdominal Tissue Plate, Lung Model). The number of instances or "samples" for each tissue type is not specified.
The data provenance is from laboratory testing, implying it was conducted by Endomagnetics Ltd. or associated testing facilities.
3. Number of Experts and Qualifications for Ground Truth
Since the studies are pre-clinical/laboratory tests focusing on device functionality and equivalence, there were no human experts used to establish a ground truth for clinical diagnostic performance. The "ground truth" here is the physical presence and detectability of the Magseed® marker within controlled laboratory settings and simulated tissues.
4. Adjudication Method for the Test Set
As there were no human experts or clinical cases requiring interpretation, an adjudication method (like 2+1, 3+1) is not applicable or described. The "ground truth" was established by the experimental setup and the known presence/absence of the Magseed® marker.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The submission focuses on device functionality and substantial equivalence for detection, not on the improvement of human reader performance with AI assistance. The Sentimag System is a non-imaging guidance system and does not involve AI for interpretation by human readers.
6. Standalone Performance Study (Algorithm Only)
The Sentimag System inherently operates in a standalone manner in its "Counts Mode" to detect the Magseed® marker. The function is the algorithm only in terms of detecting the magnetic signal and converting it into visual and audible output. The studies described (sensitivity testing, simulated use) represent this standalone performance, implicitly demonstrating that the algorithm (the detection mechanism) functions as intended. It's not an "AI algorithm" in the conventional sense that processes images or makes diagnostic recommendations, but rather a direct physical detection system.
7. Type of Ground Truth Used
The ground truth used in these pre-clinical/laboratory studies was:
- Known physical presence and location of the Magseed® marker: within the controlled laboratory environment and specific simulated tissue models.
- Controlled experimental conditions: allowing for direct measurement of the device's response to the marker.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The Sentimag System is a physical detection device, not an AI-based system that requires training data. The device's operational parameters are designed and validated, not "trained" on a dataset.
9. How Ground Truth for Training Set Was Established
As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it is not applicable. The device's detection capabilities are based on established principles of electromagnetism and magnetometry, developed through engineering design and validated through testing.
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