(135 days)
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.
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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 -
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.
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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.
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Adjudication method for the test set: Not applicable.
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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.
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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.
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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.
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The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.
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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."
§ 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.