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The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.

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This FDA clearance letter describes a new device, the "CT/MR Tandem and Ovoid Set," but it does not describe a study involving AI or software performance evaluation. The document focuses on the substantial equivalence of this physical medical device (an applicator for brachytherapy) to a predicate device, primarily through mechanical, material, and compatibility testing.

Therefore, I cannot extract information related to acceptance criteria for AI model performance or a study proving that an AI device meets acceptance criteria, as the provided text doesn't contain such a study.

The document discusses:

• Biocompatibility Testing: Ensuring the materials are safe for patient contact.
• Magnetic Resonance Testing (MR): Confirming the device is MR safe/compatible.
• Cleaning, Disinfection, and Sterilization Testing: Verifying the device can be properly cleaned and sterilized for repeated use.
• Human Factors Validation Study: To ensure the device is user-friendly and performs as intended for its users and environment.
• Mechanical and Acoustic Testing: To demonstrate the device performs as intended and meets design specifications.

These tests are for the physical device's safety and effectiveness, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fill in the requested table and details for AI-related performance.

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The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The key performance characteristics of this applicator set are as follows:

• . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
• 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
• The tandems and the pivot assembly are made from strong, lightweight titanium.
• Four different ovoid sizes to allow for varying anatomy.
• . Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
• . Ability to image the patient using CT imaging.
• Ability to image the patient using MR imaging.
• Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
• . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
• Can be manually or machine cleaned, disinfected and steam sterilizable.
• Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
• Suitable for patient contact for a period of less than 30 days

This document is a 510(k) Premarket Notification for the Titanium Flexible Geometry FSD Applicator Set (GM11013400). It does not describe an AI/ML powered device. The information provided focuses on the substantial equivalence to a predicate device through non-clinical performance testing. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, etc.) are not applicable to this submission.

Here is the information that can be extracted relevant to the performance and acceptance criteria for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission concerns a physical medical device (applicator set), not an AI/ML model for data-driven analysis. Performance testing likely involved physical prototypes or units, but specific "sample sizes" in the context of data analysis are not presented.
• Data Provenance: Not applicable in the context of clinical data used for AI/ML development. The testing described is non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, mechanical, human factors).

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

• Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the type of device and testing described. The "ground truth" for this device's performance is established by objective engineering and safety standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically for resolving discrepancies in expert labels for AI/ML 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

• No. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is based on objective engineering standards, regulatory requirements, and validated test methods. This includes:
  • Compliance with ISO 10993 for biocompatibility.
  • Compliance with ASTM standards for MR compatibility.
  • Demonstrated effectiveness for cleaning, disinfection, and sterilization.
  • Usability verification through human factors studies (IEC 62366).
  • Verification and validation against design specifications and risk management (21 CFR §820, ISO 13485, ISO 14971).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

IDENTIFY is a system for motion monitoring during radiotherapy treatment simulation and delivery. It incorporates patient safety, quality, and workflow efficiency. Its high precision SGRT cameras support proper patient positioning and enable to monitor the patient's respiratory motion and to detect intra-fraction patient position changes during the treatment.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria with reported performance metrics. The document is primarily a 510(k) summary for the IDENTIFY (4.0) device, outlining its intended use, description, and non-clinical testing for substantial equivalence to a predicate device.

Therefore, I cannot fulfill all parts of your request. I can, however, extract information about what non-clinical testing was conducted, which suggests certain underlying acceptance criteria related to safety, effectiveness, and performance against standards.

Here's what can be inferred and stated based on the provided text:

Acceptance Criteria and Study Information (Based on Inferred Information from Non-Clinical Testing Section):

The document does not present a table of explicit acceptance criteria with reported device performance in the format requested. Instead, it describes general compliance with standards and internal testing to ensure safety, effectiveness, and performance.

Inferred Acceptance Criteria from Non-Clinical Testing:

While not explicitly listed as a table of "acceptance criteria," the non-clinical testing section implies the device needed to meet the following:

• Conformance to Applicable Requirements Specifications: The device must meet its defined functional and performance specifications.
• Hazard Safeguards Functioning Properly: Safety mechanisms must work as intended.
• Software Compliance: Adherence to FDA's "Content of Premarket Submissions for Device Software Functions" guidance, specifically for a "major" level of concern.
• Electrical Safety: Compliance with IEC 60601-1 standards.
• Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 standard.
• Quality Management System: Adherence to ISO 13485.
• Risk Management: Adherence to ISO 14971.
• No Unresolved Anomalies: No Discrepancy Reports (DRs) with "Safety Intolerable" or "Customer Intolerable" priority remaining.
• Performance at least as well as Predicate Device: The device performs comparably in terms of safety and effectiveness to the IDENTIFY (K230576).

Reported Device Performance:

The document states: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." And "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US)."

Missing Information:

The document does not provide the following details that would be typically found in a clinical study report or a more detailed performance evaluation:

• A specific table of quantitative acceptance criteria and corresponding numerical performance results.
• Details on a specific "study" with a test set, sample sizes for test or training sets, data provenance, expert qualifications, or ground truth establishment methods for a clinical or performance evaluation.
• Information on MRMC studies or a human-in-the-loop effect size.
• Information on standalone algorithm performance.

Summary of Available Information from the Text:

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

   • Acceptance Criteria (Inferred): Conformance to requirements, proper functioning of hazard safeguards, compliance with specific software guidances (FDA Software Functions guidance, "major" level of concern), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), Quality Management (ISO 13485), Risk Management (ISO 14971), and absence of critical unresolved anomalies (Safety Intolerable or Customer Intolerable DRs). Performance at least as well as the predicate device.
   • Reported Device Performance: "Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable (applicable to the US)."

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

   • Not provided. The document refers to "hardware and software verification and validation testing" but does not specify sample sizes for a test set of patient data or data provenance (e.g., country of origin, retrospective/prospective). This often implies bench testing and software verification without a dedicated clinical performance study.

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

   • Not provided. This information would be relevant for a clinical performance study using expert labels, which isn't detailed here.

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

   • Not provided.

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 provided. The document focuses on the device's own performance and substantial equivalence, not an MRMC study with human readers.

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

   • The "Non-clinical Testing" section refers to "hardware and software verification and validation testing," implying performance of the device's functions, which would be "standalone" in nature. However, specific metrics or a dedicated "standalone study" in terms of clinical performance are not detailed. It's more about technical compliance.

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

   • Not specified as a formal ground truth for a clinical dataset. The "ground truth" for the non-clinical testing likely refers to engineering specifications, established safety standards, and validated software requirements.

8. The sample size for the training set:

   • Not provided. Training set information is relevant for AI/ML devices, but IDENTIFY is described as a "system for motion monitoring," not explicitly an AI/ML diagnostic or predictive device in the traditional sense that would require a large training dataset with labeled ground truth of patient outcomes.

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

   • Not applicable/Not provided. As above, a specific training set with associated ground truth is not detailed, as this appears to be a traditional medical device verification and validation rather than an AI/ML model for clinical decision support.

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Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.

Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage. Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Embozene Color-Advanced Microspheres". This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing efficacy study data with acceptance criteria for a new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission confirms that:

• The device is "substantially equivalent" to a legally marketed predicate device (K180102).
• The substantial equivalence is based on the devices having "the same indications for use and the same technological characteristics."
• The only change in the subject device is an "updated syringe due to end of life of the previously used syringe."
• Non-clinical testing (mechanical performance, biocompatibility, sterility, packaging, and shelf-life) was conducted to ensure the updated device meets the specifications of the predicate device.

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The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.

The Mould Probe MR Safe is a Brachytherapy applicator. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows:

• Suitable for intraoperative, intraluminal, and interstitial brachytherapy.
• Can be used for surface treatments in combination with the suitable Varian flap.
• Equipped with stabilizing mandrins for easy insertion.
• MR Safe, if used without mandrins.
• CT compatible, if used without mandrins.
• Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity, which prevents kinks.
• Steam sterilizable.
• Suitable for patient contact for up to 24 hours. The stainless steel mandrins are not intended to have patient contact.

The provided text is a 510(k) premarket notification summary for the "Mould Probe MR Safe" device. It describes the device, its intended use, and its comparison to a predicate device. However, this document does not contain information about the acceptance criteria and performance study outcomes related to an AI/ML device.

The document states:

• "Software Verification and Validation Testing: This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination."

Therefore, I cannot extract the requested information about acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML device from the provided text. The device in question is a physical medical instrument (brachytherapy applicator), not one that relies on AI/ML for its function.

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The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

ARIA Radiation Therapy Management (ARIA RTM) manages several treatment information such as images and treatment data to prepare plans created for treatment and review post-treatment images and records. It also provides quality assurance options. ARIA RTM does not directly act on the patient. ARIA RTM is applied by trained medical professionals in the process of preparation and management of radiotherapy treatments for patients.

The provided FDA 510(k) summary for ARIA Radiation Therapy Management System (18.1) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving device performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide a specific table of acceptance criteria or reported device performance metrics. It implies that underlying V&V documentation exists that confirms the software meets its design requirements, but these details are not present in this summary.

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

The document states: "No animal studies or clinical tests have been included in this pre-market submission." This indicates that the validation was likely based on non-clinical software testing, not patient data. Therefore, there is no patient-specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) mentioned. The testing would have involved simulated data, test cases, or internal datasets to verify software functionalities.

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

Since the testing was non-clinical software verification and validation, there is no mention of experts establishing ground truth for a test set in the traditional sense of clinical evaluation. Software testing typically relies on predefined requirements, specifications, and expected outputs, rather than expert-adjudicated ground truth from medical images or patient cases.

4. Adjudication method for the test set

Similarly, because there are no clinical trials or expert-adjudicated test sets, there is no adjudication method (e.g., 2+1, 3+1) described.

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

The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, no MRMC comparative effectiveness study was conducted or reported for this submission. The device is a radiation therapy management system, not explicitly an AI-assisted diagnostic tool for human readers.

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

The submission indicates that the software underwent "Software Verification and Validation Testing" and was considered a "major" level of concern. This implies extensive standalone algorithm (software) testing to ensure it meets its functional and safety requirements. However, specific details of these tests (e.g., test cases, scenarios, and their results) are not provided in this summary. The device "does not directly act on the patient" and is "applied by trained medical professionals," suggesting it's an assistive tool within a human workflow, but its core functionalities are tested in a standalone manner.

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

Given the non-clinical nature of the testing, the "ground truth" would have been established by the software requirements and specifications, test case design, and expected outputs defined by the developers. This is typical for software verification and validation, where the goal is to confirm the software performs as designed.

8. The sample size for the training set

The submission does not mention any training set as there is no indication of machine learning or AI models with external data training involved that would require such information. The changes appear to be feature enhancements to an existing software system.

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

As no training set is mentioned, this information is not applicable.

In summary, the provided document focuses on the regulatory aspects of a software update (v18.1) to an existing device (v18.0) and highlights software verification and validation as the primary evidence of performance. It explicitly states that no clinical or animal studies were included. Therefore, the detailed performance metrics, test set characteristics, and expert involvement typically associated with clinical efficacy studies are not present.

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The Gating Reflector Block is an accessory medical device indicated for adult and pediatric patients undergoing radiotherapy treatment simulation and/or delivery. GRB is a reusable device indicated for monitoring patient motion including respiratory patterns.

The Gating Reflector Block is a passive hardware device used for tracking the respiratory motion of the patient. It is intended to be used as an accessory to with Respiratory Gating System Scanners (K213927); TrueBeam STx™, Edge™, VitalBeam (K213977); and RPM Respiratory Gating System 1.7MR2 (K102024) to support motion management during imaging acquisition or radiation therapy treatment.

The Gating Reflector Block (Figure 01) has the following major components:

1. Body
2. Reflective Markers

The device has 4 mounted optical markers such that the reflected light can be processed by a camera to quantify the displacement of the markers, thus obtaining the patient's breathing curve.

The device consists of a plastic block and back plate and the optical markers. The optical lenses reflect the IR light wavelengths used by parent devices. Their arrangement ensures that the spatial displacement and the rotation of the block is detectable by optical monitoring systems. The alignment to the treatment room lasers is ensured by the printed alignment marks on the top and the sides of the block.

The major function of the device is to act as a surrogate device for tracking patient motion. Current parent devices track respiratory motion after placing the gating block on the chest of the patient. The IR reflectors are used by the parent devices to calculate the position and rotation of the block.

The provided text describes the regulatory filing for a medical device called the "Gating Reflector Block" (GRB). It is a passive hardware accessory used in radiotherapy to track patient motion, primarily respiratory patterns. The filing (K242874) seeks to register the GRB as an individual product, as it was previously cleared as an accessory to other Varian devices.

Based on the provided document, the device (Gating Reflector Block) is a passive hardware device and does not involve an AI algorithm, software, or human-in-the-loop performance studies as described in the prompt's requirements (e.g., MRMC studies, training/test sets, ground truth establishment for AI/software). Therefore, many of the requested details about acceptance criteria and studies (especially those related to AI/software performance) are not applicable to this specific device.

However, I can provide information based on the performance testing that was conducted for this hardware device, which focuses on safety and physical performance characteristics.

Here's a breakdown of the acceptance criteria and study information that is applicable:

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

The document does not present explicit numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/software device. Instead, the "acceptance criteria" for a passive hardware device like the GRB are met through demonstrated compliance with relevant standards and successful completion of specific non-clinical tests. The "performance" is reported as the successful demonstration of functionality and safety.

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

• Sample Size for Test Set: Not applicable in the context of an AI/software test set. The testing performed was validation and verification of the physical device and its reprocessing instructions. These tests are typically conducted on a representative sample of devices, but a "test set" in the sense of a dataset for algorithm evaluation is not relevant here.
• Data Provenance: Not applicable. This refers to physical device testing, not data collection for an algorithm.

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

• Not applicable. Ground truth establishment by experts is relevant for AI/software diagnosis/prognosis, not for a passive hardware device like the GRB. The "ground truth" for this device's performance relates to its physical properties, functionality, and safety as determined through engineering and biological testing.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are used in studies involving human interpretation or AI output, not for the physical performance validation of a hardware device.

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 study is relevant for AI-assisted diagnostic or clinical decision support software. The Gating Reflector Block is a passive hardware device for motion tracking, not an AI or software product.

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

• No. This device is a passive hardware component. It does not contain an algorithm or software. Its performance is intrinsically linked to its use within a larger system (like the Respiratory Gating System Scanners) rather than as a standalone algorithmic product.

7. The type of ground truth used

• The "ground truth" for this device's acceptance is based on:
  • Engineering specifications and measurements: For dimensions, material properties, and marker effectiveness.
  • Standardized test methods: For biocompatibility (e.g., ISO 10993 series) and cleaning validation (AAMI, ISO standards).
  • Regulatory compliance: Adherence to FDA Quality System Regulation (21 CFR §820), ISO 13485, and ISO 14971.
  • Demonstrated performance: The device "performs as intended" based on product verification and validation.

8. The sample size for the training set

• Not applicable. This device is a passive hardware component, not an AI system that requires a training set.

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

• Not applicable, as there is no training set for this hardware device.

In Summary:

The K242874 filing for the Gating Reflector Block pertains to a physical medical device accessory. The "acceptance criteria" and "study" described in the document are focused on demonstrating the device's physical performance, safety, and compatibility with existing Varian systems through non-clinical testing and adherence to established regulatory and industry standards, rather than evaluating an AI algorithm's diagnostic or predictive capabilities. The device has been on the market for 13 years with approximately 27,000 units in the field, further supporting its established performance and safety.

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The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy.

The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.

The provided text describes a 510(k) premarket notification for a medical device, the "Titanium Fletcher-Style Applicator Set Defined Geometry" and "Smit Cervical Sleeves" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/software-based device meets specific acceptance criteria through a clinical study.

The acceptance criteria and study information requested in your prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth types for training/test sets) are highly relevant for AI-powered medical devices (software as a medical device - SaMD). However, this 510(k) submission is for a physical medical device used in brachytherapy, not an AI or software device.

Therefore, many of the specific questions in your prompt are not applicable to this non-AI medical device submission. The document details the device's technical specifications, intended use, indications for use, and a comparison to a predicate device to argue for substantial equivalence. The "performance testing" mentioned is primarily non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, human factors, mechanical/acoustic testing), focusing on the device's physical properties and safety, not its diagnostic or therapeutic performance in a statistical sense that would require large clinical studies with ground truth derived from experts or pathology.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it's not applicable:

Acceptance Criteria and Device Performance (for a non-AI physical device)

The concept of "acceptance criteria" for this type of physical device is framed around demonstrating that its design and performance characteristics are equivalent to or do not raise new questions of safety and effectiveness compared to a legally marketed predicate device. The "performance" is primarily assessed through non-clinical laboratory testing to ensure physical integrity, material compatibility, and functionality within its intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred for a non-AI device through a 510(k))

Study Information (as applicable to a non-AI physical device 510(k) submission):

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

   • N/A (for clinical performance data): This is a submission for a physical device, not an AI/software device requiring a clinical test set for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to non-clinical lab tests (biocompatibility, MR, mechanical, sterilization, human factors).
   • For the non-clinical tests (e.g., sterilization cycles, human factors study), the sample size would be determined by the specific ISO/ASTM standards referenced, but typically isn't a large "test set" in the sense of clinical cases. The document does not specify these sample sizes.
   • Data Provenance: Not applicable in the context of clinical data for a physical device. Testing is conducted in a laboratory environment, not on patient data from specific countries.

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

   • N/A: Ground truth established by medical experts is not listed as a component of this non-AI device's performance testing for 510(k) clearance. The device's "performance" is assessed through engineering testing against physical and safety standards and comparison to a predicate.

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

   • N/A: Not applicable as there is no clinical test set requiring expert adjudication for accuracy or performance.

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:

   • No: This is not an AI-powered device, so an MRMC study comparing human performance with and without AI assistance was not conducted.

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

   • N/A: This is a physical medical device, not an algorithm.

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

   • N/A: "Ground truth" in the sense of clinical reference standards (pathology, expert consensus) is not applied to this type of 510(k) submission for a non-AI physical device. The "truth" or reference is established by engineering specifications, material standards, and functional test results (e.g., "does it sterilize correctly?", "is it MR compatible?").

7. The sample size for the training set:

   • N/A: This is not a machine learning/AI device, so there is no training set in the AI sense.

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

   • N/A: Not applicable.

In summary: The provided document is a 510(k) letter for a physical brachytherapy applicator set, demonstrating substantial equivalence to a predicate device. The regulatory pathway for such devices involves rigorous non-clinical testing (e.g., material testing, mechanical testing, sterilization validation) and a comparison of technical characteristics to a predicate, rather than large-scale clinical performance studies or AI-specific validation methods outlined in your prompt.

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ONCOZENE Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors including hepatoma.

ONCOZENE Microspheres (hereafter may be referenced as ONCOZENE Microspheres or ONCOZENE) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage.

ONCOZENE Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml or 3 ml of microspheres in approximately 7 ml of transport solution. The ONCOZENE Microspheres are available in 40, 75 and 100 um sizes.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a medical device called "ONCOZENE Microspheres." The document primarily addresses the substantial equivalence of a modified device (new syringe) to a previously cleared predicate device.

Based on the provided text, the device in question is a medical device (microspheres for embolization), not an AI/software-based medical device that would require the types of studies and acceptance criteria typically associated with AI performance.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance (in the context of AI performance metrics like sensitivity, specificity, AUC). The document speaks of "acceptance criteria" but in the context of physical device testing such as mechanical performance, sterilization, biocompatibility, packaging integrity, and shelf-life.
• Sample size used for the test set and data provenance (for AI model evaluation).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi reader multi case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
• Sample size for the training set (for AI models).
• How the ground truth for the training set was established (for AI models).

The document outlines the following types of performance data and their "acceptance criteria" in a general sense:

1. Non-clinical Testing: To demonstrate the design and performance met established design criteria and is substantially equivalent to the predicate device. Specifically, mechanical testing was performed to verify the Syringe Volume Identification, and results "met all related specifications."
2. Sterilization: To ensure a minimum sterility assurance level of 10⁻⁶ in accordance with ISO standards. Half and full cycles were used, and results "met all acceptance criteria."
3. Biocompatibility: In accordance with ISO 10993-1, demonstrating that patient-contacting components are biocompatible. Testing was performed for genotoxicity, hemocompatibility, cytotoxicity, implantation effects, irritation and sensitization, pyrogenicity, subacute/subchronic systemic toxicity, toxicological risk assessment of chemistry results, chemical characterization, and irritation. The text states testing "demonstrated compliance."
4. Packaging Integrity and Shelf Life: Performed in accordance with ISO 11607-1 and ISO 11607-2, supporting a three-year shelf-life. Testing included label adhesion, legibility, packaging seal integrity, bubble leak test, peel strength test, and dye penetration.

In summary of what is available in the provided text:

• Device Type: Vascular embolization device (ONCOZENE Microspheres). This is a physical medical device, not an AI/software device.
• Study Purpose: To demonstrate substantial equivalence of a device with an updated syringe to a predicate device.
• Methods: Non-clinical testing, sterilization testing, biocompatibility testing, packaging integrity, and shelf-life testing.
• Acceptance: For all listed performance data, the results "met all acceptance criteria" or "demonstrated compliance/substantial equivalence."
• Ground Truth: For these types of physical device tests, "ground truth" is typically defined by adherence to established engineering specifications, ISO standards, and regulatory requirements (e.g., a specific sterility assurance level, a certain peel strength, or passing toxicology tests).

Since the nature of the device and the provided documentation does not pertain to AI/software performance evaluation, the requested details regarding AI model acceptance criteria, test sets, expert involvement, and ground truth for AI are not applicable and thus not present in the provided text.

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The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The provided text describes a 510(k) premarket notification for a medical device called the "Heyman Packing Applicator Set (GM11004580)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a separate study with specific performance metrics (like accuracy, sensitivity, specificity, etc.) that would typically apply to AI-driven or diagnostic devices.

Instead, the "acceptance criteria" here refer to the device's conformance to established engineering standards, biocompatibility, and safety, as well as its functional characteristics. The "study that proves the device meets the acceptance criteria" is primarily a series of non-clinical performance tests and adherence to consensus standards.

Here's a breakdown of the information requested, based on the provided text:

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

Since this is a physical medical device and not an AI or diagnostic software, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they relate to functional and safety attributes. The "reported device performance" refers to the confirmed characteristics after testing.

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