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The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).

The Esteva is designed for high dose rate treatment of skin surface lesions. The Esteva utilizes a mobile treatment unit with an isotope free small 69.5 kV X-rav source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The dedicated computer system of Esteya provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that Is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy & superficial radiotherapy treatment.

The provided text is a U.S. FDA 510(k) summary for the "Esteya" X-ray radiation therapy system. It outlines the device's technical characteristics, intended use, and a comparison to predicate devices, along with a summary of performance testing (non-clinical).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document provides a table summarizing performance parameters for the device, which can be interpreted as demonstrating the device meets certain operational criteria. It does not explicitly state "acceptance criteria" but rather "Performance Data".

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

The document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate devices." This implies that there was no specific clinical test set with a sample size for human or animal subjects. The performance testing described is non-clinical, focusing on the device's physical and functional characteristics. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable to a clinical test set in this context.

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

Not applicable, as no clinical test set was used to establish substantial equivalence.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used to establish substantial equivalence.

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. The device is an X-ray radiation therapy system, not an AI-assisted diagnostic or interpretive tool. The document explicitly states "No animal or clinical tests were performed."

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

This question is not directly applicable in the context of this device. The Esteya is a radiation therapy system, not an algorithm being evaluated for standalone performance. The performance testing was focused on the system's physical and functional attributes.

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

The document indicates that "the device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria. FDA guidance, clinical use and recognized consensus standards." This suggests that the "ground truth" for the non-clinical performance evaluation was based on:

• Predetermined performance criteria: These are likely engineering and design specifications.
• FDA guidance and recognized consensus standards: These provide established benchmarks for safety and effectiveness for such devices.

8. The sample size for the training set

Not applicable. The device is an X-ray radiation therapy system, not a machine learning algorithm that requires a training set in the conventional sense.

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

Not applicable, as no training set was used for an AI algorithm.

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The Henschke Titanium Applicator Set is designed for treatment of the cervix and endometrium.

The Henschke Titanium Applicator Set is a modification of the Henschke Applicator Set (K953946). It is intended for intracavitary brachytherapy and is used for cancer treatment of the cervix and endometrium.

The Henschke Titanium Applicator Set is a gynecological applicator for Brachytherapy procedures. The applicator uses an intrauterine tube and two colpostat tubes. A colpostat cap can be placed on each colpostat tube.

The tubes guide the radioactive source of the afterloader to the location where treatment is to be applied. Transfer tubes are required to connect the applicator to the afterloader.

With the adjustable cervical stopper, the intrauterine tube-length can exactly be fitted to the patient's anatomy. The intrauterine tube has adjustment centimeter-markings.

The device is compatible with Nucletron afterloaders.

The applicator is made of Titanium and PPSU, to minimize distortion on CT imaging. This enables conformal treatment planning with the use of CT images.

This document is a 510(k) premarket notification for a medical device called the "Henschke Titanium Applicator Set." It is not a study proving the device meets specific acceptance criteria based on its performance in analyzing medical data.

Instead, this document focuses on demonstrating substantial equivalence to a previously legally marketed device (K953946, a Henschke Applicator Set). The "testing" mentioned is primarily for functional verification of the physical device and its materials, not for the accuracy or diagnostic performance of an AI algorithm or a data-driven system.

Therefore, many of the requested categories in your prompt are not applicable to the content provided. Here's a breakdown based on the information available:

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

This document does not provide a table of acceptance criteria and reported device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics for a data-driven device. The "performance" described relates to the physical device's functionality and material suitability.

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. This is not a study involving a test set of medical data for an AI/diagnostic device. The "testing" involved bench testing and user review of the physical applicator.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "ground truth" to establish in the context of diagnostic accuracy. "Experienced users reviewed the device design and executed validation tests," but their qualifications and exact number are not specified beyond "clinical personnel."

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

Not applicable. There was no test set of medical data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical applicator for brachytherapy, not an AI or diagnostic application that would involve human readers or comparative effectiveness studies of AI assistance.

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

Not applicable. This device is a physical applicator.

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

Not applicable. The "ground truth" for the testing performed relates to the device's functional specifications, material properties, and suitability for clinical use (e.g., whether it fits correctly, guides the source, minimizes CT distortion), verified through bench testing and expert review, rather than a diagnostic 'ground truth'.

8. The sample size for the training set

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

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

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

Summary of the Study/Testing (as described in the document):

The "study" or "testing" mentioned in this document is primarily focused on demonstrating the functional performance and material suitability of the Henschke Titanium Applicator Set to ensure it is safe and effective and substantially equivalent to its predicate device.

• Type of Study: Functional verification testing and bench testing. It was conducted under clinical conditions at a hospital site, involving clinical personnel, but "excluding the delivery of treatment of patients."
• Purpose: To show that the modified device (with Titanium and PPSU materials for improved CT imaging) performs as defined in requirements, meets clinical expectations, and is safe and effective for clinical use, similar to the predicate device.
• Key Findings: The new materials (Titanium and PPSU) successfully minimize distortion on CT imaging, enabling conformal treatment planning. The device maintained its core functionality, operating principle, and indications for use, making it substantially equivalent to the predicate device.
• Overall Conclusion: Nucletron concluded that the Henschke Titanium Applicator Set is substantially equivalent to its legally marketed predicate device based on the data and information presented, with no safety or effectiveness issues identified.

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Luneray is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .:

• Abdominal structures / organs (e.g. urinary . bladder)
• Head and neck (e.g. ear, lip, nose, tongue, oral . mucosa)
• Skin (e.g. keloids) .
• Soft tissue sarcoma .
  Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.

Luneray is a pre-assembled, sterile needle-catheter combination for interstitial brachytherapy treatments. The needle is inserted into the tissue and pulls the catheter through the tissue. After insertion the needle is removed from the catheter by cutting it off the catheter.
Radiation treatment planning can be based on X-ray and CT images. X-ray markers shall be used during the imaging procedure, to enable catheter reconstruction in the planning software.
The applicator is connected to a Nucletron brachytherapy afterloader for radiation treatment.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for a medical device (Luneray) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the acceptance criteria and study proving performance as typically found in clinical trials or performance verification reports.

The document discusses:

• Device description and indications for use.
• Comparison to predicate devices.
• Summary of testing: It mentions "Sterilization, Shelf Life, Biocompatibility, Functional verification testing and testing to Standards" and states that "Performance testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients." It also says, "Experienced users reviewed the device design and executed validation tests."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details on ground truth establishment for specific performance metrics.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance, as the device is a physical medical instrument, not an AI algorithm.
• Sample size for training sets, as concept of training sets is not applicable to a physical medical device.

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Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

Oncentra Brachy 4.4 is a radiation therapy treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4.4 includes all Oncentra software that is required for brachytherapy treatment planning which includes

• Anatomy Module: The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) related to the patient anatomy and target volumes for treatment planning. The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized.
• Connectivity Module: The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external sources.
• Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times.
• Evaluator Module: The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The EVAL is a read-only activity with the exception of the plan approval function.
• Volume Rendering: The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module.
• Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.

The provided document is a 510(k) summary for a medical device (Oncentra Brachy 4.4), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and a comprehensive study report in the way a clinical trial might. It describes non-clinical and clinical "testing" at a high level.

Here's an attempt to extract and present the information based on the typical requirements for acceptance criteria and study descriptions, interpreting "testing" as "study" where appropriate:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format as one would expect from a rigorous clinical study. The "acceptance criteria" are implied by the summary statements regarding verification, validation, and clinical agreement.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "test cases for each requirement, identified risk, clinical scenarios and usability issues" for non-clinical testing and "All sites" for clinical testing. No specific number of cases or patients is provided for either.
• Data Provenance: The document does not specify the country of origin for any data. Given that Nucletron B.V. is based in The Netherlands, it is possible some data could originate from there, but this is not confirmed. The nature of the studies (retrospective or prospective) is not explicitly stated. The "clinical scenarios" could imply retrospective data or simulated prospective cases.

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

• Number of Experts: Not specified. The document mentions "All sites were in agreement," implying multiple clinical sites and potentially multiple clinicians/experts, but no specific number or roles are provided.
• Qualifications of Experts: Not specified beyond the implication that they would be "qualified medical personnel" as mentioned in the "Indications for Use" for reviewing and approving treatment plans. There is no mention of their specific experience (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

Not specified. The statement "All sites were in agreement" suggests a consensus was reached, but the process (e.g., 2+1, 3+1, none) is not detailed.

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

• Was it done? No. The document does not describe a comparative effectiveness study involving human readers with and without AI (or in this case, the new calculation algorithm). The study focuses on verifying the software's functionality and alignment with clinical requirements and user expectations.
• Effect size of human readers with AI vs. without AI assistance: Not applicable, as no such study was performed or reported. The device itself is a planning software, not an AI assistance tool for human reading in the typical sense. The "AI" aspect here refers to the advanced dose calculation algorithm (ACE), not an interpretative AI.

6. Standalone (Algorithm Only) Performance Study

• Was it done? Yes, implicitly for the dose calculation algorithm. The document states, "A collapsed cone algorithm has been implemented to meet the AAPM TG 186 recommendations for brachytherapy uniformity; ACE (Advanced Dose calculation Engine) accounts for tissue heterogeneities, backscatter, attenuation, shielding and provides the user with a comparison of AAPM TG-43 and AAPM TG-186 based calculations." This suggests the algorithm's performance was evaluated against the AAPM TG 186 recommendations, which are a standard for standalone dose calculation accuracy. The non-clinical verification and validation would have assessed the algorithm's output independently.

7. Type of Ground Truth Used

• Non-clinical testing: Likely based on simulated data, phantom data, and known input-output relationships for software function verification and dose calculation accuracy based on physics principles and established standards (like AAPM TG 186).
• Clinical testing: "Clinical requirements and user expectations" likely imply a subjective assessment of the reasonableness and utility of the treatment plans generated by the software when applied to real or realistic patient cases, with "agreement" among sites/experts serving as a form of expert consensus or validation against clinical practice. It doesn't appear to be based on pathology, or long-term patient outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is a treatment planning software that implements a specific dose calculation algorithm (ACE/AAPM TG 186). It is not described as a machine learning or AI-driven diagnostic system that typically requires a "training set" in the context of supervised learning. The algorithm is based on established physics models.

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

Not applicable, as there is no mention of a training set for a machine learning model. The algorithm's "ground truth" would be the underlying physics principles and the AAPM TG 186 recommendations it was designed to adhere to.

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The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

The Fletcher CT/MR Shielded Applicator Set is a modification of the Fletcher Williamson Applicator Set (K983341). It is a gynecological applicator for brachytherapy procedures. The applicator uses one intrauterine tube and two ovoid tubes for treatment of the cervix and endometrium cancer. The tubes quide the radioactive source of the afterloader to the location where treatment is to be applied. Tungsten allov shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields. The Fletcher CT/MR Shielded Applicator Set is available in two variations and is compatible with Nucletron afterloaders and accessories.

This document is a 510(k) summary for the Nucletron BV Fletcher CT/MR Shielded Applicator Set. It acts as a premarket notification for a modified medical device. The information provided heavily focuses on demonstrating "substantial equivalence" to a predicate device rather than comprehensive clinical study data typical for a new AI/software device. As such, many of the requested fields cannot be directly extracted or are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or performance metrics in the format typically seen for a new AI/software medical device. The "acceptance criteria" here are implied by the demonstration of "substantial equivalence" to a legally marketed predicate device (Nucletron BV Fletcher Williamson Applicator Set, K983341).

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

• Test Set Sample Size: Not explicitly stated. The "testing" mentioned is primarily related to bench testing, sterilization, biological evaluation, and MR/CT compatibility. These tests typically involve a sample of the physical device, not an imaging dataset for AI evaluation.
• Data Provenance: Not applicable in the context of an AI/software device. This is a physical medical device.

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

• Number of Experts: Not applicable. Ground truth, in the context of an AI/software device, involves expert labeling of data. This document describes a physical medical device.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: 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:

• MRMC Study: No, this is not an AI/software device, but a physical brachytherapy applicator. Therefore, no MRMC study involving human readers and AI assistance was performed or described.

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

• Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: For this physical device, "ground truth" would be established through engineering specifications, material properties, physical measurements, and performance benchmarks validated against the predicate device. For example, the "truth" for shielding effectiveness would be measured dose reduction, and for imaging compatibility, it would be the quality of the CT/MR images with the device in place (e.g., artifact levels). Specific details are not provided beyond the general statement of "bench testing" and "meeting performance requirements."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is not an AI/Machine Learning device.

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

• Ground Truth for Training Set: Not applicable.

Summary Explanation:

This 510(k) summary is for a physical medical device, specifically a gynecological brachytherapy applicator. The "study" referenced is primarily bench testing, sterilization validation, biological evaluation, and MR/CT compatibility testing to demonstrate that the modified device (Fletcher CT/MR Shielded Applicator Set) is substantially equivalent to a previously legally marketed predicate device (Fletcher Williamson Applicator Set, K983341).

The document's purpose is to show that despite modifications (incorporating tungsten alloy shielding for CT/MR imaging compatibility), the new device operates on the same principle, has comparable dimensions, and meets performance requirements similar to the predicate device, with no new safety or effectiveness issues. The acceptance criteria are therefore implicit in proving this substantial equivalence across various engineering and performance attributes, rather than explicit statistical thresholds for diagnostic accuracy metrics typically associated with AI/software devices.

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The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct.

The LumenCare Azure is designed to fit in the working channel of an endoscope.

The LumenCare Azure is a modification of the Lumencath Applicator Set. It is intended for intraluminal brachytherapy and is used for treatment of the lung and any lumen that allow the insertion of this flexible applicator, e.g. bronchus and bile duct. The applicator consists of a flexible thin catheter and accessories that assist during applicator placement, imaging and treatment. The catheter fits in the working channel of an endoscope. This way, the catheter can be positioned into the treatment area under direct visual control.

The catheter of the LumenCare Azure can be delivered in three variants. These variants only differ in dimensions, i.e. catheter diameter (outer diameter and inner diameter) and total length of the catheter.

The devices are used as accessories to Nucletron afterloaders.

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance metrics in a way that allows for a direct answer to the requested table and study details.

The document states: "Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set." This indicates that some form of testing was conducted to demonstrate equivalence, but the specifics are not provided.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be gathered and what cannot:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: The document only vaguely states that "the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set." No specific quantitative or qualitative performance metrics are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size: Not specified.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable / Not mentioned. The document refers to "bench testing," which typically does not involve expert readers establishing ground truth in the same way as studies involving image interpretation.

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

• Not applicable / Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. The device is an intraluminal brachytherapy applicator, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable / Not mentioned. This device is a physical medical instrument, not an algorithm.

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

• Not explicitly stated for the "bench testing." For a physical device, ground truth would typically relate to physical properties, mechanical integrity, material performance, and functional tests against specified engineering requirements.

8. The sample size for the training set:

• Not applicable / Not mentioned. This device is a physical medical instrument, not an AI algorithm requiring a training set in the conventional sense.

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

• Not applicable / Not mentioned.

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The Esteya electronic brachytherapy system is intended to deliver x-ray radiation for suface brachytherapy procedures. Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Malingna Melanoma, Keloids and Cutaneous Lymphoma (B and T cell).

The Esteya Electronic Brachytherapy System is designed for High Dose Rate (HDR) brachytherapy treatment of skin surface lesions. The Esteya Electronic Brachytherapy System utilizes a mobile treatment unit with an isotope free small 69.5 kV X-ray source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The Esteya Electronic Brachytherapy dedicated computer system provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy treatment.

The provided text describes a Traditional 510(k) submission for the Esteya Electronic Brachytherapy System (K132092). However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device as implied by the sophisticated questions asked.

The document discusses the substantial equivalence of the Esteya system to predicate devices for delivering X-ray radiation for surface brachytherapy procedures. It mentions "non-clinical testing" and "clinical testing" but the details provided are very high-level.

Here's an analysis based on the available information:

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

• Acceptance Criteria: The document generically states that "Testing was performed in accordance with defined test cases with clearly defined acceptance criteria." However, it does not provide a specific table or list of these acceptance criteria.
• Reported Device Performance: The document states:
  • "Esteya Electronic Brachytherapy System has been tested to meet the product requirements, electrical and mechanical safety standards, and clinical expectations."
  • "The results of the clinical testing clearly demonstrated substantial equivalence of the Esteya Electronic Brachytherapy System."
  • This is a general statement of meeting requirements, not specific performance metrics against defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: This information is not provided in the document.
• Data Provenance: This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the document. The document refers to "clinical testing" and comparing "treatment output, dose distribution and clinical acceptance," but does not detail how ground truth was established or if experts were involved in a ground truth process as typically understood for AI device validation.

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

• This information is not provided in the document.

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 information is not provided and is highly unlikely to be relevant. The Esteya system is described as an "Electronic Brachytherapy System" for delivering X-ray radiation, not an AI or diagnostic imaging device that would involve "human readers" or AI assistance in interpretation. The context of an MRMC study and "human readers improve with AI" does not fit the description of this device.

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

• This information is not provided and is not relevant, as the device is a treatment delivery system, not a diagnostic algorithm.

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

• The document implies that "treatment output, dose distribution and clinical acceptance" were compared. This suggests a ground truth related to physical dosimetry and clinical outcomes/acceptance of the treatment process. However, the exact type of ground truth (e.g., specific pathology reports, long-term patient outcomes, or expert consensus on treatment efficacy) for its "clinical testing" is not explicitly stated or detailed.

8. The sample size for the training set

• This information is not provided and is irrelevant as the Esteya system is a hardware device for radiation delivery, not a machine learning algorithm that requires a training set.

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

• This information is not provided and is irrelevant for the same reason as point 8.

In summary:

The provided 510(k) summary is for a physical medical device (an electronic brachytherapy system) and lacks the specific details that would be found in a submission for an AI/algorithm-based device, particularly concerning acceptance criteria, ground truth establishment, expert involvement, and study designs like MRMC or standalone algorithm performance. The information available focuses on demonstrating substantial equivalence in design, technology, functionality, and overall clinical performance to existing predicate devices, rather than validating an AI algorithm against specific performance metrics for diagnosis or prediction.

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