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With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.

Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating.

With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated.

With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately.

With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion.

Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.

The Klarity SGRT System (ARSG-E1A, ARSG-E3A) is a surface-guided radiation therapy solution. The following table outlines its acceptance criteria and reported performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set. It mentions "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications". The provenance of the data for these non-clinical tests is not specified in terms of country of origin or whether it was retrospective or prospective.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The studies mentioned are non-clinical performance and comparative tests, not expert-opinion based evaluations.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for a test set, as no clinical study involving human judgment is detailed.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The clinical test is not applicable, there's no clinical data."

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

Yes, numerous standalone performance tests were conducted. The document states: "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications...". This includes specific performance metrics like measurement accuracy, reproducibility, and respiratory gating accuracy. These tests inherently evaluate the algorithm's performance in a standalone manner, separate from human intervention in a clinical setting.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" would be established by precise physical measurements and reference systems used during these engineering and performance verification tests. This is not derived from expert consensus, pathology, or outcomes data, but rather from direct physical measurement.

8. The Sample Size for the Training Set

The document does not provide information about the sample size for a training set. As the device is referred to as "advanced software" and performs tasks like 3D image registration and real-time motion monitoring, it likely involves algorithms that would require training data, but details are not disclosed.

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

The document does not provide information on how the ground truth for any potential training set was established.

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1. Klarity SRS Baseplate: The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning, repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
2. Klarity Promise Baseplate: The device is indicated to position and or immobilize adult and pediativ undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the pabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Not Found

The provided text is an FDA 510(k) clearance letter for the Klarity SRS Baseplate and Klarity Promise Baseplate. It grants clearance for these devices but does not contain information about acceptance criteria or specific study results proving the device meets them.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the clearance is based on a determination of substantial equivalence to a predicate device, not on clinical performance data demonstrating specific acceptance criteria.

The information you are requesting, such as performance metrics, sample sizes, expert qualifications, and ground truth methodologies, would typically be found in the 510(k) submission itself or related study reports, which are not part of this FDA clearance letter.

Therefore, I cannot provide the requested information based on the input text.

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Klarity Bolus is indicated for radiation therapy clinical treatments as a tissue equivalent aid to correct for anatomical irregularities and deliver a prescribed dose to the skin and underlying tissue. Target population is Adult, Child and Infant, and Federal (USA) law restricts this device to sale by, or on the order of a physician.

Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV electron energy levels. Further testing will be required to confirm performance with proton therapy systems.

Klarity Bolus is a moldable gel sheet material to be used by trained radiation therapy professionals as an aid to radiation treatment of uneven areas of a patient, such as at the nose or ears, to make up for missing tissue, or to provide build-up of radiation dose to the skin surface. The use of bolus is decided by a doctor or professional on a case by case basis, deciding if bolus is needed or appropriate, and deciding the amount and shape of the bolus material to be used.

During radiation therapy treatments there can often be a "build up" of radiation dose a few millimeters beneath the surface of a patient's skin. Bolus material can be used to create a simulated layer of tissue that will raise the depth of the "build up" to be closer to actual skin level. This can benefit the accuracy and dose level for treating a skin cancer, for example. Bolus materials have been used for this purpose for many years.

Klarity Bolus is provided as a non-sterile 30x30cm sheet in various thicknesses from 0.5cm to 4cm. Klarity Bolus incorporates a thin mesh netting in the sheet to enhance dimensional stability and prevent easy tearing. In clinical use a therapist will use scissors to cut the sheet into a desired shape. Klarity Bolus is tacky and self-adherent, so it can be layered to a desired thickness. The shaped piece will be placed on the patient's skin in a chosen location, where it will adhere enough to stay in place but can be easily removed. Klarity Bolus has less tackiness than other bolus materials, a manufacturing choice made in response to clinician complaints about the oily and overly tacky surface of other bolus materials. Sheets are semi-transparent, allowing a therapist to see the underlying treatment area.

Klarity Bolus is for single patient use only, and can be discarded with normal hospital waste. For cleanliness reasons, gloves should be worn when working with bolus sheets.

Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV and 12MeV electron energy levels. Results compare favorably with the predicate device and other bolus materials. Further testing will be required to confirm performance with proton therapy systems.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria or any of the other requested information related to an AI/ML device study. The document is an FDA 510(k) premarket notification for a medical device called "Klarity Bolus", which is a physical bolus material used in radiation therapy.

It describes:

• The indications for use of the Klarity Bolus.
• Its physical characteristics and how it is used.
• A comparison to a predicate device.
• Non-clinical performance data, specifically:
  • Biocompatibility testing (Cytotoxicity, Skin Sensitization, Skin Irritation).
  • Tissue equivalency testing at specific photon and electron energy levels.
  • Element content and Zeff values.

It explicitly states that "Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV and 12 MeV electron energy levels. Results compare favorably with the predicate device and other bolus materials." This refers to physical testing of the bolus material itself, not the performance of an AI/ML device or algorithm.

Therefore, I cannot provide the requested information.

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To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors.

Patients are those that have been diagnosed and are undergoing treatment for cancerous turnors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

Klarity Vacuum Cushions: The Klarity Vacuum Cushions are similarly constructed with a polyurethane coated nylon material. The vacuum bags are filled with small polystyrene spheres. The Klarity Vacuum cushions are airtight and fitted with a self-closing valve for ease of use. When air is evacuated, the cushions contract to hold a rigid shape over the course of the radiation therapy treatment.

Klarity Mold Cushions: The cushion has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150° F. The thermoplastic layer has a nylon stockinette material surrounding it, for patient comfort.

The provided text describes two medical devices, Klarity Vacuum Cushions and Klarity Mold Cushions, and their 510(k) submission for substantial equivalence. It does not contain information about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The submission focuses on demonstrating equivalence to predicate devices based on design, construction, intended use, and functioning, rather than presenting new performance data against statistical acceptance criteria.

Therefore, many sections of the requested information cannot be filled from the provided text.

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

Klarity Patient Immobilization Devices: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not specified. The submission relies on a comparison to predicate devices rather than independent testing of a specific sample size.
• Data Provenance: Not applicable, as no new performance data or clinical study results are presented. The claims are based on the similarity to previously cleared devices.

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

• Not applicable. No ground truth was established by experts for a test set, as no independent performance study was conducted. The equivalence is established by comparing device characteristics to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring adjudication was used.

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

• No MRMC comparative effectiveness study was done. The submission is not focused on demonstrating an improvement in human reader performance with AI assistance, as these are physical immobilization devices without an AI component.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Not applicable. These are physical patient immobilization devices, not algorithms. The concept of "standalone performance" as it relates to AI algorithms does not apply here.

7. Type of Ground Truth Used:

• Not applicable. The basis for clearance is substantial equivalence to predicate devices. This means the device is deemed safe and effective because it shares similar technological characteristics and intended use with devices already on the market (Klarity Vacuum Cushions to Bionix SecureVac Immobilization System, and Klarity Mold Cushions to Civco MoldCare/AccuForm™). No "ground truth" in the clinical performance sense was established for these specific Klarity devices.

8. Sample Size for the Training Set:

• Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets.

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

• Not applicable. No training set was used.

Summary of Device Equivalence Justification provided in the 510(k) submission:

• Klarity Vacuum Cushions:

  • Predicate Device: The SecureVac Immobilization System (K040773) manufactured by Bionix Development Corporation.
  • Basis for Equivalence:
    • Similar Construction: Both use polyurethane coated nylon material and are filled with small polystyrene spheres.
    • Similar Function: Both are sealed airtight with self-closing valves. Both work by evacuating air, causing the cushion to contract and hold a rigid, patient-conforming shape.
    • Similar Clinical Use: Both are used for positioning and repositioning patients during external-beam radiation therapy in the same manner.
    • Conclusion: Based on similarity in design, construction, and function, it is reasonable to expect similar properties, attenuation factors, and performance regarding use, safety, and effectiveness.

• Klarity Mold Cushions:

  • Predicate Device: The MoldCare head and neck cushion (K982624) marketed by Civco (now AccuForm™).
  • Basis for Equivalence:
    • Similar Intended Use: Both are designed for positioning and repositioning patients receiving external-beam radiation therapy.
    • Similar Outcome: Both harden to create a firm, patient-conforming support cushion.
    • Differing Mechanism (but achieving similar function):
      • Predicate (MoldCare): Polystyrene spheres mixed with a water-activated resin, hardening after water application (approx. 10 minutes).
      • Klarity Mold Cushions: Polystyrene spheres surrounded by a 1/16" layer of polycaprolactone thermoplastic. This material softens at 150°F (using oven or hot water bath) and becomes moldable for 5-8 minutes as it cools, then hardens. The thermoplastic technology is noted as commonly used in other radiation therapy devices (e.g., Klarity thermoplastic masks, 510(k)#022708).
    • Conclusion: Despite a different hardening mechanism, the devices achieve the same clinical function of conforming to and stabilizing the patient for radiation therapy, leading to a conclusion of substantial equivalence in use, safety, and effectiveness.

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