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The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue.

The Sirius Pintuition Detector is intended only for the non-imaging detection of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

The Sirius Pintuition Seed and Sirius Pintuition Detector (consisting of Base Unit and Probe) are part of the Sirius Pintuition Localization System.

The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. The device is supplied single-use, sterile and pre-loaded within its delivery needle (7cm, 12cm or 20cm length variants).

The Pintuition Detector is designed to detect the presence and proximity of the implanted Pintuition Seed. It consists of a mains-powered, table-top Pintuition Base Unit, and a cableconnected, reusable Pintuition Probe. Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during surgery to plan the surgical approach and quide surgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm).

The principle of operation is magnetism, the Pintuition Seed is associated with a magnetic field which the Pintuition Detector utilizes to determine the location of the Pintuition Seed.

Here's a summary of the acceptance criteria and study information for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria for performance (e.g., a specific accuracy threshold or a certain rate of successful localization). Instead, it lists various pre-clinical tests and a clinical evaluation to demonstrate safety and performance.

However, based on the Summary of Technological Characteristics and the Summary of Non-Clinical Performance Data, we can infer the aspects that were evaluated to ensure the device performs as intended:

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

The document states: "An analysis of available data was conducted to evaluate and characterize the clinical safety and performance of the Sirius Pintuition Localization System. The clinical data support the safety and performance of the device: Clinical Evaluation, including clinical safety and performance data with the actual device, a previous version of the device and an extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices in various soft tissue types."

• Sample Size: The document does not specify a numerical sample size for the test set of the clinical evaluation. It refers to "available data," "clinical safety and performance data," and "extensive evaluation of available literature data."
• Data Provenance: The data provenance is described as a combination of:
  • Data from the "actual device" (implying prospective or recent retrospective studies specific to this version).
  • Data from a "previous version of the device."
  • "Extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices." This indicates that the provenance is varied and includes retrospective literature reviews.
  • Country of Origin: The country of origin for the clinical data is not specified in the provided text.

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

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). The clinical evaluation is broad and references existing clinical data and literature.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore does not provide an effect size for human readers with vs. without AI assistance. The device in question (Sirius Pintuition) is a localization system, not an AI software intended to assist human readers in image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Sirius Pintuition system is designed to be used by a human operator ("Using the Pintuition Probe, a user may use the Pintuition Detector prior to and during surgery to plan the surgical approach and guidesurgery. The location of the seed is fed back to the user using audible and visual cues (distance in mm)").

Therefore, a standalone performance study without human-in-the-loop would not be applicable or relevant to its intended use, and the document does not describe such a study. The "System accuracy and range verification" under non-clinical data would assess the device's inherent capability, but always within the context of a user interacting with it.

7. Type of Ground Truth Used

Based on the description of the device's function (locating and surgically removing the target tissue along with the implanted seed), the ground truth for clinical evaluation would likely involve:

• Pathology: To confirm whether the resected tissue contained the target lesion and the implanted seed.
• Surgical Confirmation: Direct visual or palpation confirmation during surgery of successful seed and lesion removal.
• Imaging Confirmation: Post-operative imaging (e.g., X-ray, ultrasound) to confirm removal of the seed and, if applicable, the target lesion.

The document does not explicitly state "pathology" or "outcome data" as ground truth, but given the indication for surgical removal, these are the most logical forms of truth. The clinical evaluation supported "safety and performance," which inherently relies on such confirmation.

8. Sample Size for the Training Set

The Sirius Pintuition system is a hardware device for localization based on magnetic principles, not a machine learning or AI algorithm in the context of image analysis that typically requires a "training set." Therefore, the concept of a "training set" in the context of an algorithm or AI is not applicable to this device as described.

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

As the concept of a "training set" doesn't apply to this type of device, this question is not relevant to the information provided.

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The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (

The Sirius Pintuition Seed and Sirius Pintuition Detector are part of the Sirius Pintuition Localization System.

The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is intended to be placed percutaneously in the breast for temporary (

This document is a marketing approval letter from the FDA for the Sirius Pintuition Seed, Sirius Pintuition Probe, and Sirius Pintuition Base Unit, with a focus on a modification related to the resterilization of the Sirius Pintuition Probe. As such, the information provided primarily relates to demonstrating the substantial equivalence of the modified device to its predicate, rather than a full, de novo study proving the initial efficacy of the entire system.

Therefore, many of the requested data points (like sample size for test set, number of experts for ground truth, MRMC study, training set size, etc.) are not explicitly present in the provided text as this is a 510(k) "Special" submission, indicating a modification to an already cleared device. The focus is on verifying the impact of the modification (resterilization) on safety and performance, rather than re-proving the original device's effectiveness.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's overall performance (e.g., specific accuracy metrics). Instead, it focuses on demonstrating that the modification (resterilization) does not negatively impact the established safety and performance of the device.

The reported device performance is largely a qualitative statement of comparability to the predicate device due to the nature of a Special 510(k).

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

• Sample Size: Not specified in the provided document. The testing involved "ADDITIONAL: Sterilization validation and functional compatibility testing" along with other elements like design verification, system accuracy/range verification, biocompatibility, MR safety, packaging, shelf life, and electrical safety. These tests would involve various samples of the device and its components, but specific numbers are not given.
• Data Provenance: Not explicitly stated, though Sirius Medical Systems B.V. is based in the Netherlands. The tests are described as "pre-clinical testing."

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

Not applicable/specified. This document describes pre-clinical validation studies relating to a device modification (resterilization), not a study evaluating human performance or diagnostic accuracy that would typically involve expert-established ground truth on a test set of clinical cases.

4. Adjudication Method for the Test Set

Not applicable/specified. This type of information is generally relevant for studies involving human interpretation or diagnostic decision-making using images or clinical data, where conflicting expert opinions might need to be resolved. This document pertains to validation of a physical device modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this particular submission. The submission is a "Special 510(k)" for a modification (resterilization of the probe) to an already cleared device. MRMC studies are typically used to evaluate the diagnostic accuracy of the entire system (algorithm + human reader) in clinical use, which would have been part of the original device's clearance or a new, significant indication. This document references a "Clinical Evaluation, including clinical safety and performance data with the actual device, a previous version of the device and an extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices," but this is not the same as an MRMC study on the effectiveness of AI assistance.

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

Not applicable. The Sirius Pintuition System is a localization system that relies on a physical probe and magnetic seed for non-imaging detection and localization, guided by a human user. There isn't an "algorithm-only" component in the sense of an AI-driven image analysis tool. The device provides "audible and visual cues (distance in mm)" to the user.

7. The Type of Ground Truth Used for the Test Set

The concept of "ground truth" in the context of this submission (a device modification for resterilization) is related to objective physical and biological parameters:

• Sterility Validation: Absence of viable microorganisms after sterilization.
• Functional Compatibility: The device operating within specified performance parameters (e.g., accuracy, range) after resterilization.
• Biocompatibility: Absence of adverse biological reactions to the device materials.
• Safety Standards: Compliance with electrical safety and MR safety standards.

These are established through laboratory testing and engineering verification, not typically through expert consensus, pathology, or outcomes data in the typical sense for diagnostic algorithms.

8. The Sample Size for the Training Set

Not applicable/specified. The Sirius Pintuition System is a magnetic localization device, not an AI/machine learning algorithm that requires a "training set" in the traditional sense of image or clinical data for model development. The system operates based on established physical principles of magnetism.

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

Not applicable. As mentioned above, there isn't a "training set" for this type of device. The system's functionality is based on physics and engineered specifications.

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The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark temporarily (

The Sirius Pintuition Seed and Sirius Pintuition Detector are part of the Sirius Pintuition Localization System.

The Sirius Pintuition Seed is a small (1.65 x 5mm) Titanium tissue marker that is intended to be placed percutaneously in the breast for temporary (

The provided text is a 510(k) Premarket Notification for the Sirius Pintuition Localization System. While it discusses the device's intended use, technological characteristics, and a summary of non-clinical and clinical performance data, it does not explicitly detail a study proving the device meets acceptance criteria in the format or with the specific quantitative data requested in your prompt.

Specifically, the document states:

• "Testing was conducted to evaluate and characterize the safety and performance of the Sirius Pintuition Localization System. Pre-clinical testing included: Design verification, System accuracy and range verification..." (page 18, section 5.7). This indicates that such tests were performed, but the document does not provide the acceptance criteria table or the reported device performance results from these tests.
• "An analysis of available data was conducted to evaluate and characterize the clinical safety and performance of the Sirius Pintuition Localization System. The clinical data support the safety and effectiveness of the device: Clinical Evaluation, including clinical safety and performance data with the actual device, a previous version of the device and an extensive evaluation of available literature data pertaining to the previous version device, the predicate device and additional benchmark devices." (page 18, section 5.8). This describes a clinical evaluation based on various data sources, but it does not outline a specific comparative clinical study (like an MRMC study) or provide details on how "safety and effectiveness" were quantified for this specific device against defined criteria.

Therefore, I cannot extract the information required to populate the fields in your request comprehensively from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing quantitative performance against specific acceptance criteria in a comprehensive study report.

In summary, the document lacks the specific details required for:

1. A table of acceptance criteria and reported device performance: No such table or detailed performance data is present.
2. Sample size and data provenance for the test set: Not specified for any quantitative clinical or performance test.
3. Number of experts and qualifications for ground truth: Not applicable as no explicit 'ground truth' establishment for a diagnostic test is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study details (effect size, human readers improvement): No such study is mentioned or detailed. The clinical evaluation refers to literature reviews and data from previous versions/predicate, not a direct human reader study with this device.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for device performance (rather than diagnostic accuracy).
8. Sample size for training set: Not applicable, as it's not an AI model.
9. How ground truth for training set was established: Not applicable.

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The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (

The RFID Localization System (RFLS) is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the tag. The RFLS is comprised of a Tag, Tag Applicator, Reader, and Surgical Probe. The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.

The provided text details the 510(k) summary for the RFID Localization System (RFLS). While it outlines various performance tests conducted, it does not provide a specific table of acceptance criteria with corresponding reported device performance, nor does it detail a comparative effectiveness study involving human readers (MRMC). The information focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Based on the provided text, here's an attempt to answer the questions, highlighting what information is available and what is not:

Acceptance Criteria and Study for RFID Localization System (RFLS)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported performance for each criterion. It broadly states that "performance testing was conducted to evaluate and characterize the performance of the RFLS."

However, one specific performance metric is mentioned under "Localization Accuracy" in the comparison table:

Other performance aspects mentioned (without specific numerical criteria or reported values):

• RFLS System Verification
• Reader/Probe Design Verification
• Localizer System and Component Accuracy, Repeatability Evaluation
• Test Media Evaluation
• Reader and Surgical Probe Operating Environment Evaluation
• Tissue Marker Migration Evaluation
• Usability Verification and Validation
• Electrosurgical tool compatibility
• EMC/Safety Testing
• Biocompatibility
• Magnetic Resonance Testing
• Packaging Validation
• Sterilization Validation

The document states that these tests "demonstrates the safety of the system for its intended use and confirms the performance of the system for use in intra-operative surgical guidance. Specifically, the performance testing demonstrates the safe use of the system to facilitate intra-operative guided surgical procedures by detecting the presence of the Tag by providing an audible tone which increases pitch and volume with decreased distance, a visible bar indicator, and a measurement readout."

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

The document does not specify the sample sizes used for the various performance tests (e.g., number of RFLS tags tested, number of measurement repetitions for accuracy, etc.).

It also does not detail the data provenance in terms of country of origin or whether the studies were retrospective or prospective. Given that this is a 510(k) summary for a medical device cleared by the FDA (USA), it's highly probable the testing was conducted in the USA, but this is not explicitly stated. The tests are described as "non-clinical testing," implying they were not conducted on human patients.

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

The document does not mention the use of experts or the establishment of ground truth by experts for the described performance tests. The tests appear to be primarily engineering and bench-top evaluations (e.g., accuracy, repeatability, EMC, sterilization validation) rather than studies requiring expert clinical judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as expert involvement and clinical ground truth establishment are not described for the non-clinical performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how human readers improve with AI vs. without AI assistance. The RFLS is a localization device, not an AI-assisted diagnostic tool that would typically involve comparative reader studies for diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance testing appears to be primarily focused on the standalone performance of the device's components and system operation (e.g., localization accuracy of ±7mm, detection of the tag, providing audible tone and visible indicators). The device's function is explicit: "The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal." This implies an "algorithm only" type of measurement in terms of its core function, but it's part of a human-guided surgical procedure.

7. The Type of Ground Truth Used

For "Localization Accuracy (±7 mm)," the ground truth would likely be established by a highly precise physical measurement system (e.g., an optical tracking system, a precisely calibrated measurement jig) during bench testing, rather than expert consensus, pathology, or outcomes data, as it's a direct physical measurement. For other tests like "Sterilization Validation" or "Biocompatibility," the ground truth would be adherence to established standards and test protocols.

8. The Sample Size for the Training Set

The document does not mention a training set. The RFLS is described as a marker-with-detector localization device, relying on RFID technology for detection and distance measurement. This does not suggest the use of machine learning or algorithms that require a distinct "training set" in the conventional sense (e.g., for image classification or prediction). The device's function appears to be based on direct physical principles of radiofrequency wave detection rather than learned patterns from a training dataset.

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

Not applicable, as a training set is not mentioned.

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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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The Cianna Medical Tissue Marker is intended to be placed percutaneously in the breast to temporarily (

The Cianna Medical Tissue Marker and Delivery System is comprised of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) in the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging.. The Cianna Medical Tissue Marker and Delivery System is provided sterile, and is for single use only.

The provided text describes the Cianna Medical Tissue Marker and Delivery System and its 510(k) submission (K120804). However, it does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic performance or clinical effectiveness.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device's technological characteristics, intended use, and principle of operation to predicate devices (K102506, K111692, K090501).
• Non-Clinical Performance Data: This section details various biocompatibility and material safety tests performed on the device components (e.g., cytotoxicity, sensitization, systemic toxicity, pyrogenicity, mutagenicity, implantation). These are common tests for implantable medical devices to ensure safety and material compatibility.
• Clinical Data: Explicitly states, "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."

Therefore, based on the provided text, I cannot provide the requested information about acceptance criteria for diagnostic performance or a study demonstrating the device meets such criteria because:

1. No acceptance criteria for diagnostic performance are listed. The "acceptance criteria" discussed are implicitly related to the "Pass" or "Fail" results of the non-clinical (biocompatibility) tests.
2. No study demonstrating the device meets diagnostic performance criteria is described. The document states that no clinical data was used for substantial equivalence.

If you are looking for information regarding the diagnostic performance of a device (e.g., sensitivity, specificity, AUC), that kind of data is not present in this 510(k) summary. This document primarily demonstrates the safety and material compatibility of the tissue marker and its substantial equivalence to existing markers based on design and intended use, not its diagnostic accuracy in identifying or characterizing a medical condition.

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