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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.

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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The Endomag Sentimark® Magnetic Marker is intended to be placed percutaneously in the breast to mark temporarily (

The Sentimag System is intended for the non-imaging detection and localization of the Sentimark Magnetic Marker that has been implanted in a lumpectomy site intended for surqical removal. The Sentimag System and Sentimark Magnetic Marker System are designed for use in an operating room environment by suitably trained physicians who are experienced in diagnosis and treatment of breast lesions. The Sentimag System aids the surgeon to detect surgically invasively magnetic marker material that has been placed for the purpose of detecting a non-palpable lesion, and to locate target excision sites. Prior to a lumpectomy procedure, the Sentimark Magnetic Marker is placed percutaneously into the breast, using imaging quidance such as ultrasound or radiography, to temporarily mark a site intended for surgical removal. During a surgical procedure, the hand-held Sentimaq probe emits an alternating magnetic field that detects the magnetic response of the Sentimark magnetic marker, this signal is converted by the base unit into a visual and audible response that is similar in use to the predicate device.

The provided document is a 510(k) premarket notification for the Sentimag System and Sentimark Magnetic Marker System, which means it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for an AI/ML device.

Therefore, the requested information regarding "acceptance criteria" for device performance, given the context of an AI/ML device study, and "the study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic performance, is not directly available or applicable in this document. The document describes non-clinical performance testing for a medical device that uses magnetic detection, not an AI/ML algorithm.

However, I can extract information regarding the non-clinical tests performed to demonstrate substantial equivalence to the predicate device.

Information Extracted from the Document:

The document describes non-clinical performance tests to evaluate and characterize the Sentimag System and Sentimark Magnetic Marker System. These tests are conducted to demonstrate substantial equivalence to the predicate device, not to establish AI/ML diagnostic performance against predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable/provided in the context of an AI/ML device study. The document lists "Pre-clinical testing included:" followed by bullet points. These are tests for the physical device, not an AI/ML algorithm's performance metrics like sensitivity, specificity, or AUC against clinical ground truth.

   Acceptance Criteria (Implied)	Reported Device Performance
   Functional Performance	Demonstrated through:
   	- Dimensional Verification
   	- Insertion, Deployment and Withdrawal Force
   	- MRI Compatibility
   	- Simulated Use
   Biocompatibility	Demonstrated through:
   	- 28-Day GLP Implantation Trial

2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are pre-clinical (e.g., dimensional verification, force testing, MRI compatibility, simulated use, and a GLP implantation trial), not on a clinical test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic AI/ML algorithms (e.g., expert consensus on clinical images) is not relevant for the described pre-clinical device performance tests.

4. Adjudication method for the test set: Not applicable.

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. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device for magnetic detection, not an AI algorithm.

7. The type of ground truth used: For the "28-Day GLP Implantation Trial," the ground truth would likely be histological analysis and observation of the implanted device in animal models to assess biocompatibility and lack of adverse reactions. For other tests like "Dimensional Verification," the ground truth would be engineering specifications and measurements. This is a hardware device, not an AI/ML algorithm.

8. The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary from the Document regarding Device Performance:

The Sentimag System and Sentimark Magnetic Marker System underwent various non-clinical tests to demonstrate their performance and safety, ultimately supporting the claim of substantial equivalence to the predicate device (Cianna Medical Tissue Marker and Delivery System K120804). The tests included:

• Dimensional Verification
• Insertion, Deployment, and Withdrawal Force
• MRI Compatibility
• Simulated Use
• A 28-Day GLP Implantation Trial

The submitter concludes that "The detailed technological characteristics of the two systems have been identified and compared. The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness." and "The test, verification and validation data presented in this submission demonstrate substantial equivalence of the Sentimag Magnetic Marker System."

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