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This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system provides cranial and head and neck fixation and stereotactic localization with automatic software fiducial localization. It is intended to be used during both Computed Tomography (acquisition of the imaging series used for the patient's treatment plan) and each of the patient radiation treatments.

The Aktina Pinpoint Head and Neck Stereotactic Localizer, Part Number 50-100, is used for the localization and fixation of patients undergoing stereotactic radiotherapy and radiosurgery of the cranial area, as well as radiotherapy of the head and neck area. Fixation is accomplished via two components: a customized Dental Tray that with the aid of slight vacuum suction fixes to the roof of the patient's mouth, and a customized head and neck support. Localization is accomplished via two components: a hardware component which comprises of a Stereotactic Fiducial Frame that is positioned over the patient's treatment area while being accurately interfaced to the Dental Tray, and a software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame. The Fiducial Frames are used during the patient's initial CT and then as a setup target box for each treatment thereafter.

The K103616 510(k) submission for the "Pinpoint Stereotactic Head and Neck Localizer" does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for submissions involving AI/software with performance metrics.

This submission is for a physical medical device (a head and neck fixation system with stereotactic localization hardware and software). The emphasis is on proving substantial equivalence to a predicate device, as opposed to demonstrating specific diagnostic or predictive performance metrics.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The key reported performance is that "Hardware specification testing has been performed to show that the verification, validation and safety requirements have been met." This is a general statement, not a specific performance metric. |

Reasoning for Absence: The submission focuses on proving substantial equivalence to a predicate device, which had previously demonstrated its safety and effectiveness. The modifications to the device (new mouthpiece design with external vacuum port) are described as not altering its fundamental form, fit, or function, thus not requiring new performance studies with specific acceptance criteria in the context of diagnostic accuracy.

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

• Sample Size: Not applicable/not provided. This is a hardware device with localization software, not a diagnostic AI system evaluated on a dataset of patient images.
• Data Provenance: Not applicable/not provided.

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

• Not applicable. Ground truth establishment by experts for a test set of data is not relevant for this type of device submission.

4. Adjudication Method for the Test Set:

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic or interpretation system. The "software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame" is a localization algorithm, not a system for human reader interpretation improvement.

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

• The submission mentions a "software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame." While this is an algorithm, the 510(k) does not describe a standalone performance study with metrics like accuracy, sensitivity, or specificity for this software component. The focus is on the overall system's equivalence. Hardware specification testing is mentioned, which would include verification of the integrated system's function.

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

• Not applicable in the context of evaluating a diagnostic or predictive algorithm. For the localization software, the "ground truth" would likely involve precise physical measurements of the fiducial frame and geometric validation against CT scans, rather than clinical ground truth from patient data.

8. The sample size for the training set:

• Not applicable. There is no mention of a machine learning training set for an AI model in this submission. The software component described is likely based on deterministic algorithms for coordinate system determination, rather than a learned model.

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

• Not applicable.

Summary of the Study per the 510(k):

The "study" presented in this 510(k) is primarily a substantial equivalence comparison to a predicate device, rather than a detailed performance study with quantitative acceptance criteria for a new AI or diagnostic algorithm.

The core of the "study" is outlined in Section 7, "Performance Standards and Data," and Section 9, "Summary of Substantial Equivalence":

• Performance Data: "Hardware specification testing has been performed to show that the verification, validation and safety requirements have been met." This suggests internal testing against engineering specifications, but specific metrics are not disclosed in this summary.
• Biocompatibility: The new mouthpiece components were evaluated against ISO-10993-1, demonstrating biocompatibility for surface contact of less than 24 hours.

The FDA's decision to clear the device K103616 relies on its similarity in design and intended use to the predicate device (K081935), with the conclusion that "No new issues of safety or effectiveness are introduced by using this device." This implies that the predicate device's established safety and performance profile is leveraged for the current device due to their high degree of similarity and the minor nature of the changes.

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This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system providen creatial and head and neck fixation and stereotactic localization with automatic software fiducial location. It is intended to be used during both Computed Tomography (acquisition of the imagiong series used for the patient's treatment plan) and each of the patient radiation free on ants.

The Aktina Head and Neck Stereotactic Localizer, Part Number 50-100, is used for the localization and fixation of patients undergoing stereotactic radiotherapy and radiosurgery of the cranial area, as well as radiotherapy of the head and neck area. Fixation is accomplished via two components: a customized Dental Tray that with the aid of slight vacuum suction fixes to the roof of the patient's mouth, and a customized head and neck support. Localization is accomplished via two components: a hardware component which comprises of a Stereotactic Fiducial Frame that is positioned over the patient's treatment area while being accurately interfaced to the Dental Tray, and a software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame. The Fiducial Frames are used during the patient's initial CT and then as a setup target box for each treatment thereafter.

The provided text, K081935, describes a medical device, the Stereotactic Head and Neck Localizer. However, it does not contain the detailed study information required to fill out all aspects of your request regarding acceptance criteria and device performance studies.

The document primarily focuses on:

• General provisions of the device (trade name, owner).
• Classification and predicate devices.
• Description and intended use.
• Technological characteristics and comparison to predicate devices.
• Biocompatibility information.
• A summary of substantial equivalence to predicate devices, asserting no new safety or effectiveness issues.
• A letter from the FDA confirming substantial equivalence and market authorization.

Crucially, under "7. Performance Standards and Data", it states: "Hardware and software specification testing have been performed on the Stereotactic Head and Neck Localizer to show that the verification, validation and safety requirements have been met." However, it does not report the specific acceptance criteria, quantitative results, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.

Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies as this information is not present in the given text.

Below is a partial response based on the information available in the document, along with explicit notes about what information is missing.

Acceptance Criteria and Device Performance Study Details for K081935

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in the document.
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the document. The device is a physical localization and fixation system with a software component for fiducial localization, rather than an AI-assisted diagnostic tool that typically involves human reader performance evaluation.

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

• The document states that "Hardware and software specification testing have been performed... to show that the verification, validation and safety requirements have been met." This strongly suggests standalone testing of the software's ability to determine "the coordinate system of the patient within the fiducial frame" and "automatic software fiducial localization." However, specific results, metrics, or details of these standalone tests are not provided.

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

• Type of Ground Truth: Not specified for the software's localization capabilities. For a device of this nature, ground truth would likely involve precise physical measurements from a phantom or highly accurate imaging modalities to verify the software's calculated coordinates against known physical positions. However, this is not explicitly stated.

8. The sample size for the training set

• Sample Size (Training Set): Not specified in the document.

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

• How Ground Truth was Established: Not specified in the document.

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External Beam Radiation Therapy is typically delivered to patients from a linear accelerator or from a radioactive source (high and low dose rate variants). Aktina Medical Physics Corporation has designed and manufactured software to aid in the verification of the delivery process prior to patient treatment. The software analyzes and compares the predicted data from a radiotherapy treatment planning system and measured dose measurements.

The intended purpose of the Protos Software is to provide a Radiation Therapy Quality Control (QC) tool that allows for the automated and rapid comparison of predicted and measured radiation dose values. The software is intended for the QC of external beam radiation treatments. Measured data will be acquired from radiographic films. Predicted data will be calculated in a Radiotherapy Treatment Planning System (RTPS) and transferred to the software via a Digital Imaging and Communications in Medicine (DICOM) protocol.

The provided 510(k) summary for the Protos Software describes its intended use and technological characteristics in comparison to a predicate device, but it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Radiological Imaging Technology, Inc., RIT 113 Film Analysis System, K935928). It highlights that both systems share similar technological characteristics and are used for the same purpose: providing a Radiation Therapy Quality Control (QC) tool for comparing predicted and measured radiation dose values.

Therefore, I cannot populate the requested table or answer most of your detailed questions regarding acceptance criteria and performance studies based on the provided text.

Here's what information I can extract and what is missing:

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External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

AKTINA Medical Phvsics Corporation has designed and manufactured a replacement table top of Carbon Fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber is provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

The provided document (K032248) is a 510(k) premarket notification for a medical device: "Precise Carbon Fiber Table Top". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove effectiveness with specific performance metrics against acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC or standalone AI performance) is not applicable to this type of regulatory submission. The document explicitly states that "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product," which further indicates that specific, predefined acceptance criteria and a detailed study proving performance against them are not required or provided in this context.

The summary emphasizes substantial equivalence to predicate devices (Elekta AB, K983678 and AKTINA Medical Physics Corporation, K991546), focusing on similar design, intended use, and performance characteristics, and asserting that "No new issues of safety or effectiveness are introduced by using this device." The demonstration of safety and effectiveness for such a device would primarily revolve around material properties (biocompatibility, structural integrity, radiolucency) and compatibility with existing patient support systems, rather than diagnostic accuracy or human performance improvement.

Given these limitations, here's a breakdown of what can be extracted and what is not available from the provided text:

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

Note: The document does not provide specific quantitative acceptance criteria (e.g., maximum deflection under load, specific radiolucency percentages) or quantitative performance data, but rather states qualitative claims of compliance and equivalence.

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 / Not provided. This type of device (a patient support table top) does not typically involve a "test set" or "training set" in the context of diagnostic or AI performance evaluation. The "evaluation of product testing" mentioned for biocompatibility and "field experience for equivalent applications" would likely refer to engineering tests and general clinical usage knowledge for similar devices, not a formal study with a defined patient sample size.

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 provided. Ground truth establishment by experts is relevant for diagnostic devices (e.g., image analysis algorithms). This device is a component of a radiation therapy system, and its evaluation would not involve expert ground truthing in that manner.

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

• Not applicable / Not provided. See point 3.

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 / Not done. MRMC studies are used for evaluating diagnostic performance, often related to AI applications. This device is not an AI-driven diagnostic tool.

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

• Not applicable / Not done. See point 5.

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

• Not applicable / Not provided. The "ground truth" for this device would be established through engineering specifications, material science evaluations, and compatibility testing with the Elekta Precise Patient Support System, rather than clinical ground truth methods like pathology or outcomes data.

8. The sample size for the training set

• Not applicable / Not provided. See point 2.

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

• Not applicable / Not provided. See point 2 and 7.

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The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams.

The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams. This physical device is constructed of high-density materials that differentially attenuate the transmitted radiation beam.

The provided text describes a 510(k) premarket notification for a medical device and therefore does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission for a Class II medical device (Radiation Therapy Wedges) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria. The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed device, not necessarily to present a de novo performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details of a study proving the device meets acceptance criteria.
• Sample size used for a test set or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
• Details on a standalone algorithm performance study.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

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Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.

The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.

This appears to be a 510(k) submission for a non-diagnostic device (a 'Tennis Racquet Insert' for radiation therapy patient support), not a diagnostic AI device. Therefore, the provided documents do not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or AI performance that are typically associated with diagnostic AI systems.

The submission focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating performance of a diagnostic algorithm.

Here's a breakdown of why this information is missing:

• Acceptance Criteria/Reported Performance: These are typically for diagnostic accuracy (sensitivity, specificity, AUC) or other quantifiable performance metrics. This device doesn't have such metrics. Its "performance" is about supporting a patient without introducing new safety/effectiveness issues compared to similar devices.
• Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these points relate specifically to studies designed to evaluate the accuracy and reliability of a diagnostic algorithm, often against a human gold standard or pathology. This device is a physical support apparatus, not a diagnostic tool, so these types of studies were not applicable or performed.

What the document does state regarding "performance":

• Performance Standards: "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tennis Racquet Inserts." This indicates there are no specific, pre-defined quantitative performance metrics for this type of device from the FDA.
• Summary of Substantial Equivalence: "This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device." This is the core "performance" claim – that it performs identically to existing, legally marketed devices.

In summary, because this device is a physical medical device for patient support during radiation therapy, and not an AI-powered diagnostic tool, the typical criteria and study design questions you've asked are not applicable to the provided documentation.

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The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.

Tilt Boards are also commonly known as Breast Boards and are intended for use in Radiation Therapy to facilitate patient positioning in irradiation of the breast.

The AKTINA Medical Physics Corporation Tilt Board is intended for use in Radiation Therapy as an aid in patient positioning for breast treatments.

This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices.

The provided text describes a 510(k) submission for a medical device called the "Tilt Board" (also known as a Breast Board). This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the provided document does not contain acceptance criteria for device performance or any study data proving the device meets specific performance criteria. The submission primarily focuses on:

• General Provisions: Trade name, applicant, predicate devices, classification, and performance standards (not established by FDA).
• Intended Use and Device Description: Used for patient positioning in radiation therapy for breast treatments.
• Biocompatibility: No studies undertaken as no patient contact and no new materials.
• Summary of Substantial Equivalence: States similarity in design, construction, materials, intended use, and performance to predicate devices, introducing no new safety or effectiveness issues.
• FDA Response Letter: Confirms substantial equivalence based on the provided information and allows marketing.
• Indications for Use: Reiterates the intended use.

Therefore, I cannot provide the requested information as it is not present in the given text.

The document is a regulatory submission for a Class II medical device, where the primary path to market is often through demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data against specific acceptance criteria. For devices like a "Tilt Board" which are positioning aids and not directly diagnostic or therapeutic in themselves, the "performance" often refers to basic functional safety (e.g., structural integrity, ease of use, stability) and alignment with the intended use of patient positioning, rather than a quantifiable clinical outcome requiring extensive studies with ground truth.

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In Radiation Therapy and Diagnostic Radiology, an ongoing quality assurance program is essential for ensuring the overall quality of patient care. As part of the overall quality assurance program daily, monthly and annual tests to validate machine output, field size indicators, and general machine geometry are performed. In order to obtain reproducible results, these tests must be Since machine with the same conditions, with the same physical parameters. Since machine output and field size are directly related to the geometry of the test conditions it is important that the distance from the beam source to the test device is consistent. The Aktina Medical Physics Corporation Mechanical Frontpointer is designed to provide this ability. By utilizing the fixed geometry of the accessory mount system on a linear accelerator, a rigid based for measuring distance can be obtained. The Mechanical Frontpointer presented in this notification functions exactly as a standard mechanical tape measure however by being attached to a frame which slides into the accessory mount a reproducible setup is ensured.

The AKTINA Medical Physics Corporation Mechanical Frontpointer is intended for use in Medical Physics Quality Assurance. The intended use of this device is to provide a reproducible and accurate mechanism for the setup of test objects and equipment used in quality control and calibrations by medical physicists. The Mechanical Frontpointer is mounted in the accessory slot of the treatment machine and is not in contact with the patient at any time when in use.

The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating the device meets such criteria. The document is a 510(k) summary for the "Mechanical Frontpointer," which is a device for medical physics quality assurance, used to provide a reproducible and accurate mechanism for the setup of test objects and equipment.

The document focuses on:

• General Provisions: Trade name, common name, applicant information.
• Predicate Devices: Sears Tape Measure and Elekta Oncology Systems Mechanical Frontpointer K874558.
• Classification: Class I and Class II device classifications.
• Performance Standards: Notes that FDA has not established performance standards for Mechanical Frontpointers.
• Intended Use and Device Description: Explains its function in medical physics quality assurance for reproducible setup of test objects and equipment.
• Biocompatibility: States no studies were undertaken as the device does not contact the patient.
• Summary of Substantial Equivalence: Claims similarity in design, construction, materials, intended use, and performance to predicate devices without introducing new safety/effectiveness issues.
• FDA Clearance Letter: Official communication from FDA stating clearance based on substantial equivalence.
• Indications for Use: Details its role in radiation therapy and diagnostic radiology quality assurance for reproducible setup.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or MRMC studies, as these details are not present in the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

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In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the charing In Nation Therapy, It is often nobsoad fields can be achieved by supplementing the shaping the shaping desired treatment shape. Integral shaped that system with tertiary beam blocks. These Beam Blocks are used to further collimate and contour the treatment field.

This device is intended to be used in Radiation Therapy for creating irregularly shaping treatment fields.

This looks like a 510(k) premarket notification for a medical device. The document states that the device is "substantially equivalent" to a predicate device, meaning it doesn't introduce new safety or effectiveness issues. The following information is not available in the provided text:

• Acceptance criteria and reported device performance (no specific performance metrics or testing results are provided)
• Sample size for the test set or data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• Method for establishing ground truth for the training set

This type of submission focuses on demonstrating equivalence to an existing device rather than presenting detailed performance studies against specific acceptance criteria.

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