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The SAVI Scout Reflector 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, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

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The provided text is a 510(k) clearance letter from the FDA for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market entry.

However, the letter does not contain any information about acceptance criteria for device performance or a study proving that the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness data.

Therefore, I cannot provide the requested information from the given text. The document is solely a regulatory approval letter and does not include details on performance metrics, study design, or results.

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The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

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The provided documentation is an FDA 510(k) clearance letter for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. It confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive submission summary.

Therefore, I cannot provide a complete answer to your request, as the critical information regarding acceptance criteria, reported device performance, study details (sample size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment for training and test sets) is not present in the provided text.

The document only states the "Indications for Use" for the device:

• SAVI Scout Reflector: Intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System), the Reflector is located and surgically removed with the target tissue.
• SAVI Scout System: Intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.

To answer your questions, I would need access to the actual clinical study report or a more detailed summary of the performance testing that was submitted to the FDA for this device.

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The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (

SAVI Scout Reflector and SAVI Scout System

This document is primarily a 510(k) clearance letter from the FDA for the SAVI Scout Reflector and SAVI Scout System, along with the device's Indications for Use. It does not contain the detailed study information (acceptance criteria, performance data, sample sizes, expert qualifications, ground truth establishment, etc.) that would typically be found in a clinical study report or a more comprehensive FDA submission summary.

Therefore, for the information requested in the prompt, the document provides none of the required details. It is a regulatory clearance document, not a clinical study report.

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

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The provided document is a 510(k) summary letter from the FDA to Cianna Medical, Inc. for the SGS Tissue Marker and System. This document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

Specifically, the document:

• Confirms substantial equivalence to a predicate device.
• Lists the indications for use of the device (to temporarily mark a lumpectomy site in the breast and for non-imaging detection of the marker).
• States regulatory information such as the regulation number, class, and product code.
• Provides contact information for FDA divisions.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Information about standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, one would typically need to refer to the full 510(k) submission document, which often contains detailed technical and clinical study reports. The FDA 510(k) summary (which this document effectively is) summarizes the key findings but generally omits detailed study methodology and raw data.

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The Cianna Medical Permanent Tissue Marker is intended to mark tissue during a percutaneous breast biopsy procedure and be permanently visible by radiography and visible for up to thirty days by ultrasound.

The Cianna Medical Permanent Tissue Marker and Delivery System consists 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) within the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging. The Cianna Medical Permanent Tissue Marker and Delivery System is provided sterile, and is for single use only.

The provided text describes the non-clinical performance evaluation of the Cianna Medical Permanent Tissue Marker and Delivery System, focusing on biocompatibility. It explicitly states that no clinical data was used to determine substantial equivalence. Therefore, there is no information about acceptance criteria for device performance in a clinical setting, nor any study proving the device meets such criteria.

However, I can provide the acceptance criteria and results for the non-clinical performance data as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set Sample Size: Not applicable. The document describes non-clinical, in-vitro, and in-vivo animal (mouse, guinea pig, rabbit) tests for biocompatibility, not human clinical test sets. The sample sizes for each specific biocompatibility test are not detailed in this summary.
• Data Provenance: Not specified, but given the nature of the tests (ISO standards), these are laboratory-based studies.

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

• Not applicable. Ground truth typically refers to clinical or pathological assessment in human studies. For these non-clinical tests, the "ground truth" is established by adherence to the specified ISO standards and validated laboratory methodologies, performed by qualified laboratory personnel.

4. Adjudication method for the test set:

• Not applicable. These are not studies requiring adjudication by multiple experts in the sense of clinical image review. The results are based on standardized laboratory protocols and interpretations.

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. The document explicitly states: "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices." This is not an AI-assisted device, nor does it involve human readers interpreting images in a clinical setting.

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

• No. This is a physical medical device (tissue marker), not an algorithm or AI system.

7. The type of ground truth used:

• Non-Clinical Biocompatibility Standards: The "ground truth" for the non-clinical tests is based on the established safety thresholds and methodologies defined by the specific ISO 10993 series standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation and sensitization, ISO 10993-11 for systemic toxicity, ISO 10993-3 for genotoxicity, and ISO 10993-6 for local effects after implantation). These standards provide the basis for evaluating material safety.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. There is no training set for this device.

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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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The Cianna S1, Single Lumen Balloon Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

The Cianna S1 Single Lumen Balloon Applicator is a specialized applicator that is temporarily inserted into the target volume to facilitate the application of radiation to the target site in the treatment of carcinoma. The Cianna S1 Single Lumen Balloon Applicator is provided sterile for single use and is disposable.

The provided text describes the Cianna S1, Single Lumen Balloon Applicator, a medical device for brachytherapy. However, the text does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/ML context.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance studies with acceptance criteria in the way a clinical or AI/ML performance study would.

Here's a breakdown of what is provided and what is missing based on your request:

Acceptance Criteria and Reported Device Performance

The provided text states: "Performance testing was conducted to evaluate and characterize the performance of the Cianna S1 Single Lumen Balloon Applicator. Preclinical testing conducted included valve and syringe stability, balloon inflation diameter assessment, afterloader compatibility, closed system verification and biocompatibility testing per ISO 10993-1. The Cianna S1 Single Lumen Balloon Applicator performed as intended and met all acceptance criteria."

This is a general statement. Specific acceptance criteria (thresholds or metrics) and the detailed results demonstrating how those criteria were met are NOT provided in the text. For example, it doesn't specify what the acceptable range for "balloon inflation diameter" was, nor the actual measured diameter.

Information NOT available in the provided text, as it pertains to AI/ML or detailed clinical study specifics:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is neither an AI/ML device nor a clinical trial report with a test set of patient data. The "testing" mentioned refers to engineering and biocompatibility checks.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this is not an AI-assisted device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.

The SAVI Preparation Device is a specialized catheter with an inflatable balloon at the distal end. The SAVI Preparation Device is temporarily implanted in the lumpeon at the access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytheray applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator. The SAVI Preparation Device is provided sterile for single use and is disposable.

The provided text describes a 510(k) summary for the SAVI Preparation Device. However, it does not contain explicit acceptance criteria or a detailed study description with performance metrics that would allow for the completion of the requested table and information points.

The document states:

• "All necessary verification and validation testing has been performed for the SAVI Preparation Device to assure substantial equivalence to the predicate devices." (Section 6, Page 20)
• It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a novel functionality.

Therefore, I cannot provide the requested information in the structured format because the necessary data is not present in the given text.

This document focuses on the regulatory submission process for substantial equivalence, not a detailed performance study against specific acceptance criteria for a new AI/software device. It's for a physical medical device (catheter) used in brachytherapy.

If this were a document about a software/AI device, it would typically include a dedicated "Performance Data" section with clinical or technical study outcomes, statistical analyses, and a comparison to acceptance criteria.

To answer your request, I would need a different type of document, specifically one detailing the clinical or technical performance study of the device against its acceptance criteria.

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The SAVI Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.

Let's break down the information provided about the Cianna Medical SAVI Applicator Kit (K081677) to address your questions.

It's important to note that this 510(k) submission is for a medical device (applicator) used in brachytherapy, not an AI or software-as-a-medical-device (SaMD) product. Therefore, many of the questions related to AI performance metrics, ground truth establishment, and training/test sets for algorithms are not directly applicable or discussed in this type of submission. The focus here is on demonstrating substantial equivalence to predicate devices through physical performance testing and intended use.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format for performance metrics that would be analogous to sensitivity, specificity, or accuracy for an AI system. Instead, the performance testing focuses on demonstrating the integrity, suitability, and substantial equivalence of the device through engineering and biocompatibility tests.

The typical acceptance criteria for a device like this would revolve around its physical properties, sterility, dimensional accuracy, material compatibility, and functionality as an accessory to existing brachytherapy equipment.

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

This is not applicable in the context of an AI/SaMD study for this device. The "test set" for this physical device would involve a series of engineering tests on a sample of manufactured applicators to verify physical properties, rather than a clinical dataset for an algorithm. The document does not provide details on the number of units tested for physical performance.

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

This question is not applicable. The "ground truth" for a physical medical device like the SAVI applicator is established through engineering and biological testing against predefined specifications and regulatory standards, not expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data (e.g., medical images for an AI system). For a physical device, performance is typically assessed against objective test methods and specifications.

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

This question is not applicable. The SAVI Applicator is a physical medical device, not an AI system or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

This question is not applicable. The SAVI Applicator is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be:

• Engineering specifications: Compliance with design drawings, material properties, and dimensional tolerances.
• Sterility standards: Confirmation of adherence to established sterilization protocols.
• Biocompatibility standards: Evidence that the materials are safe for human contact per ISO 10993 or equivalent standards.
• Functionality verification: Demonstrating that the device can successfully integrate and function with remote afterloading equipment as intended.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI system that requires a "training set" of data.

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

This question is not applicable. As there is no AI algorithm, there is no training set or ground truth in that context.

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The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.

This submission for the SAVI Applicator Kit (K080565) from Cianna Medical, Inc. is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparability rather than extensive new clinical trial data with specific acceptance criteria and detailed performance metrics as one might find for a novel, high-risk device.

Based on the provided text, a detailed table of acceptance criteria and reported device performance, as well as an effect size from an MRMC study, sample size for training/test sets, or information about expert ground truth adjudication, are not explicitly stated or applicable in the context of this 510(k) submission.

Here's a breakdown of the available information according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as a quantifiable table with specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity). The submission's "Performance Data Summary" states: "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."

The conclusion further states: "Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SAVI Applicator is determined to be substantially equivalent to existing legally marketed devices."

This implies that the performance demonstration was to show that the SAVI Applicator performs at least as well (or equivalently) to its predicate devices for its intended use, rather than meeting specific numerical performance targets.

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

Not applicable/Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, often supported by bench testing and sometimes small clinical studies for specific aspects if there are significant technological differences. The document does not describe a traditional clinical study with a "test set" in the context of AI or diagnostic device performance evaluation.

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

Not applicable/Not provided. As there's no described "test set" and ground truth establishment in the context of AI or diagnostic performance, this information is not present.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No information provided. This is unlikely for a device of this nature and type of submission (510(k) for substantial equivalence of an accessory device).

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

Not applicable/Not provided. The SAVI Applicator is a physical medical device (an accessory to brachytherapy equipment), not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable/Not provided in the context of a "test set" evaluation. The "ground truth" for this device's approval is its substantial equivalence to predicate devices, meaning it meets the same functional and safety requirements that previous similar devices have already established.

8. The Sample Size for the Training Set

Not applicable/Not provided. This is not an AI or machine learning device.

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

Not applicable/Not provided.

Summary of Device and Approval Context:

The SAVI Applicator is an "accessory to commercially available remote afterloading equipment used during brachytherapy procedures." Its function is to "provide pathways from which a prescribed radiation dose is delivered to the treatment area."

The approval (K080565) is based on a 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices (Biolucent Applicator K062830, K061241, K070659).

The "Performance Data Summary" indicates that "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." This typically involves bench testing, material compatibility, and engineering analyses to ensure the device performs as intended and is as safe and effective as the predicate devices.

Key FDA Limitation: The FDA, in its approval letter (K080565), imposed a specific warning: "The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This highlights that while the device was found substantially equivalent for its intended accessory use, its potential broader implication as a replacement therapy had not been proven and required a specific disclaimer.

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