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The Endomag Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Endomag Magseed Pro Magnetic Marker is intended for use as a soft tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Magseed Pro Magnetic Marker is a sterile, single use device composed of a selfexpanding four-sided tetrahedral nitinol structure, with side lengths of 6.3 mm with a magnetic core. The device is not inherently magnetic. It is capable of being magnetized and located by Endomagnetics' Sentimag Gen 2 or Gen 3 devices. The Magseed Pro Magnetic Marker comes preloaded in a 17-gauge needle delivery system.

The Magseed Pro Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site intended for surgical removal. The Magseed Pro Magnetic Marker is subsequently localized by using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimage Systems, Sentimag Gen 3 K222832 or Sentimag Gen 2 K153044). The marker can be detected up to 45 mm from the Sentimage probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.

Additionally, Magseed Pro can be used in combination with Sentimag Gen 3 in Measure mode. When used in this modality, the distance between the location of Magseed Pro and the tip of the Sentimag Gen 3 probe can be measured. This distance is graphically displayed on the LCD screen of Sentimag Gen 3 in this mode.

Based on the provided text, the device in question is the "Magseed Pro Magnetic Marker System." The document describes its acceptance criteria and the study conducted to prove it meets them.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the document lists "Dimensional verification," "Robustness testing," "Insertion, deployment and withdrawal force testing," "MRI Compatibility," "Biocompatibility testing per ISO 10993-1," and "Corrosion testing" as performance tests, it does not explicitly state numerical acceptance criteria or detailed results for these. However, the overall conclusion of substantial equivalence implies they met their internal acceptance criteria.

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

• Sample Size: 60 patients.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical performance testing" conducted in patients, implying prospective data collection during the study.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. The ground truth appears to be based on direct clinical observation (successful retrieval) and pathological examination (target region excised, absence of unexpected tissue responses).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be derived directly from the outcomes of the surgical procedures and subsequent pathological assessments.

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, an MRMC comparative effectiveness study involving human readers assisting with or without AI was not conducted. This device is a physical marker and delivery system, not an AI-powered diagnostic tool. The clinical study focused on its physical performance (placement, retrieval, safety).

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

This question is not applicable. The device is a physical marker, not an algorithm or software. Its performance is evaluated in conjunction with human use (placement, surgical removal) and detection systems (Sentimag Gen 2/3).

7. The Type of Ground Truth Used

The ground truth used was:

• Clinical Efficacy: Successful physical retrieval of the marker and excision of the target tissue during surgery.
• Pathology: Histological examination of excised tissue to confirm target region removal and assess for unexpected tissue responses.
• Outcomes Data: Observation of device-related adverse events.

8. The Sample Size for the Training Set

The document does not mention a training set, as this is a physical device and not a machine learning model. The clinical study involved 60 patients for performance and safety evaluation.

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

Not applicable, as there was no training set for a machine learning model.

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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 Magseed® Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Endomaq Maqseed® Magnetic Marker is intended for use as a tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Magseed Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site that is for example intended for surgical removal. The Magseed Magnetic Marker is subsequently localized by using imaging quidance (such as ultrasound or radiography) or aided by non-imaging quidance (Endomag Sentimag® System, K153044 and K163541). The marker can be detected up to 3cm from the Sentimag® probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.

Based on the provided text, the device in question is the Endomag Magseed® Magnetic Marker, which is a tissue marker. The document is a 510(k) summary for its premarket notification.

It's important to note that this document does not describe a study proving the device meets specific acceptance criteria related to an AI/algorithm's performance. Instead, it details the non-clinical testing done to demonstrate the substantial equivalence of the Magseed Magnetic Marker to predicate devices for its intended use as a radiographic tissue marker.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance, effect size) are not applicable to this specific device submission as described in the provided text.

The information primarily focuses on the device's physical properties, biocompatibility, and performance in simulated use, not an AI or algorithmic diagnostic performance.

Here's a breakdown of the information that can be extracted or inferred from the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of acceptance criteria for a diagnostic performance study as would be seen for an AI/algorithm. Instead, it states that "Testing was conducted to evaluate and characterize the safety and performance of the Magseed Magnetic Marker." The acceptance here is based on demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of a "test set" for a diagnostic performance study. The document refers to "Pre-clinical testing included: Biological Evaluation, Simulated Use." The specific number of samples or instances tested for these evaluations is not mentioned.
• Data Provenance: Not specified (e.g., country, retrospective/prospective). This type of detail is typically for clinical performance studies, which are not the focus of this 510(k) for a tissue marker.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This information pertains to studies establishing ground truth for diagnostic AI/algorithms. This device is a passive tissue marker, not an AI/algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. This refers to methods for resolving discrepancies in expert labeling for AI ground truth.

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:

• Not Applicable. This device is not an AI for diagnostic interpretation, nor does it assist human readers in that capacity.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests, the "ground truth" would be established by engineering tests, material standards, and biological compatibility standards. For example, in biological evaluation, the "ground truth" is compliance with ISO standards for biocompatibility. For "simulated use," the "ground truth" is successful physical performance under conditions mimicking clinical use. There is no "ground truth" in the sense of a medical diagnosis.

8. The sample size for the training set:

• Not Applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. As above, no training set.

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

The Magseed Magnetic Marker is identical to the Sentimark Magentic marker described in K153044. Only the trade name has changed. The Magseed Magnetic Marker is supplied to end users as a pre-packaged sterile, single-use delivery system. The system comprises an individual soft magnetic marker (magnetic seed) and a 18-gauge needle delivery system that is used to deliver the seed to the intended deployment location. This product is designed as a single use device that is supplied sterile in an individual sealed tyvek pouch.

This Premarket Submission is solely concerned with a reduction in the length of the 18-gauge needle cannula that is used to introduce the Magseed Magnetic Marker. K153044 describes two device configurations, where:

• REF: SM18-1-12 has a length of 12cm
• REF: SM18-1-20 has a length of 20cm

This submission solely considers a reduction in the needle canulla to a minimum length of 5cm.

• REF: SM18-1-05 has a length of 5cm .
• REF: SM18-1-07 has a length of 7cm .

There is no revision to the implanted marker.

The Sentimag Detector remains identical to that described in K153044

The Sentimag System is intended for the non-imaging detection and localization of the Magseed Magnetic Marker that has been implanted in a lumpectomy site intended for surgical removal.

The Sentimag System and Magseed 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 Magseed 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 surqical procedure, the hand-held Sentimag probe emits an alternating maqnetic field that detects the magnetic response of the Magseed 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.

This document is a 510(k) premarket notification for a medical device called the "Magseed Magnetic Marker System." It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (K153044), particularly regarding a reduction in the length of the needle cannula used for delivery.

Based on the provided text, the document does not describe a study involving acceptance criteria and device performance in the context of human reader performance or algorithm-only performance for AI/ML devices. The submission is for a physical medical device (a tissue marker and its detection system), not an AI/ML algorithm.

Therefore, the requested information categories (#1-9) which are typical for AI/ML device studies, are largely not applicable to this document. The document describes a traditional medical device submission where equivalence is established through demonstrating that changes (like needle length) do not introduce new questions of safety or effectiveness, often relying on non-clinical testing and comparison to a predicate.

Here's the breakdown of why each point is not directly addressed by the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. This document is not evaluating the performance of an AI/ML model against specific 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): Not applicable. There is no "test set" in the context of an AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic AI/ML algorithm is described.
4. Adjudication method (e.g. 2+1, 3+1, none) 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: Not applicable. This device does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. The "ground truth" for this device would be its physical properties, sterility, safe implantation, and accurate detection, which are assessed through engineering tests and clinical use, not a labeled dataset.
8. The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The document describes a 510(k) submission for the Magseed Magnetic Marker System, which is a physical device used to mark lesions in the breast for surgical removal. The current submission is primarily to gain clearance for reduced needle cannula lengths (5cm, 7cm) compared to previously cleared lengths (12cm, 20cm).

The core of the submission relies on demonstrating that these shorter needles do not introduce new questions of safety or effectiveness because:

• The implanted marker ("Magseed Magnetic Marker") remains identical to the predicate device component.
• The detection system ("Sentimag System") remains identical to the predicate device.
• There are no revisions in device materials or processes for the common design elements.
• The product risk management file was reviewed, and no additional risks were identified for the shorter cannulas.

Therefore, the "study" proving the device meets acceptance criteria is implicitly the demonstration of substantial equivalence through technical comparisons and a risk assessment, rather than a clinical trial or AI/ML performance study as typically understood in the context of acceptance criteria tables.

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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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