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The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes.

It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles.

The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).

The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes.

It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles.

The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).

The provided document is an FDA 510(k) clearance letter for the "Qfix Radiotherapy Chair". It does not contain information about the acceptance criteria and study proving device performance as typically expected for software or AI/ML devices. This document is a regulatory approval for a physical medical device, not a software algorithm.

Therefore, I cannot answer your specific questions about acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided text. The document primarily focuses on FDA's determination of substantial equivalence for a physical radiotherapy support and fixation device.

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Embrace Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Embrace Thermoplastic from Bionix Development Corporation is a moldable lowtemperature thermoplastic comprised of polycaprolactone, a biodegradable thermoplastic polymer that has been approved by the Food and Drug Administration for other medical device applications.

Embrace Thermoplastic becomes pliable and moldable by hand at temperatures of about 160 to 170 degrees Fahrenheit. This heating is most often done by immersion in hot water. To improve the ease of handling the polycaprolactone material in its heated, softened state, the Embrace Thermoplastic sheets will be bonded to a non-low temperature rigid thermoplastic frame. These frames also serve as convenient points to affix the Embrace Thermoplastic to an underlying patient support device.

Embrace Thermoplastic will be supplied in a variety of configurations and sizes, depending on the size and location of the body part to be immobilized, and to enable compatibility with other radiation therapy immobilization devices already in use. The Embrace Thermoplastic sheets may be perforated to enhance an even stretch over anatomical protuberances such as the nose and chin. This improves the conformity and rigidity of the resulting mask by preventing over-stretching and thinning in these areas. Perforation patterns may be uniform (as in a sheet intended to be used over a limb) or variable (such as in a sheet intended to be used with the head), all designed to enhance the even stretch of the material and the rigidity of the resultant mask.

The typical application of Embrace Thermoplastic is to create a conformal "mask" of an anatomical body part, such as the head, by stretching the pliable heated polycaprolactone sheet over the body part and allowing it to cool and become rigid. The resulting conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.

Here's a breakdown of the acceptance criteria and study information for the Embrace Thermoplastic, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is marketed as substantially equivalent to predicate devices, meaning its performance is considered acceptable if it is comparable to these devices. The acceptance criteria are implicitly defined by the performance characteristics of the predicate devices.

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

• Test Set Sample Size: The document does not specify a distinct "test set" in the context of typical machine learning or diagnostic device studies. Instead, samples of each thermoplastic material (Embrace, Klarity, Aquaplast) were used for bench testing. The exact number of individual samples tested for each attribute (e.g., number of rigidity measurements) is not provided, but it implies a sufficient number for representative physical and radiation attenuation measurements.
• Data Provenance: The data is generated from bench testing of the actual materials. No mention of geographical origin or retrospective/prospective nature is applicable as it's not human subject data.

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

Not applicable. The ground truth for physical properties (rigidity, shrinkage, melting point, etc.) and radiation attenuation for this type of medical device is established through instrumental measurements and standardized testing methods, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as the "ground truth" is derived from direct instrumental measurements, not human interpretation requiring adjudication.

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

No. This study is focused on the physical and radiation-attenuation properties of a thermoplastic material used for patient immobilization. It does not involve human readers interpreting medical images or making diagnoses, thus an MRMC study is not relevant.

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

Not applicable. This device is a physical product (a thermoplastic), not an algorithm or software. Therefore, there is no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth used in this study is based on direct physical measurements and instrumental radiation attenuation measurements. These are objective, quantifiable properties of the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and the study involves bench testing of its properties. There is no machine learning model being trained, and therefore no "training set."

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

Not applicable, as there is no training set.

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Klarity thermoplastic is intended for use by licensed physicians and trained radiation therapy professionals for the external support and stabilization of patients undergoing radiation therapy treatment in a licensed clinical setting.

Klarity™ is a "low temperature" Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F. (68° C.). Heating is best done by immersion in hot water. Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "Substantially equivalent to Aquaplast™ Thermoplastic ([K935067](https://510k.innolitics.com/search/K935067)) in chemical composition, method of manufacture, physical appearance, physical characteristics, and intended use.",
      "Pliant and moldable by hand when heated to 155° F (68° C).",
      "To be used for stabilization of patients undergoing external beam Radiation Therapy.",
      "To be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions."
    ],
    "Reported Device Performance": [
      "Klarity™ is equivalent to the predicate device in its chemical composition, method of manufacture, physical appearance, physical characteristics and intended use, verified by knowledge of the chemistry of the predicate device and physical testing.",
      "Klarity™ is a 'low temperature' Thermoplastic, which is pliant and moldable by hand when heated to a temperature of 155° F (68° C).",
      "Klarity™ Thermoplastic is to be used by, or under the supervision of licensed physicians for the stabilization of patients undergoing external beam Radiation Therapy.",
      "Klarity™ Thermoplastic is to be sold in sheets of thickness from 1.6mm to 3.2mm, in a variety of dimensions chosen to be compatible with similar devices already in use."
    ]
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not applicable. The submission is for a material (thermoplastic) used for patient stabilization, not a diagnostic or AI device that relies on a test dataset of patient data. The 'testing' involved physical characteristics of the material itself and comparison to a predicate device.",
  "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. Ground truth for patient data is not relevant for this device. The 'ground truth' for substantial equivalence was established via comparison to the predicate device and physical characteristics validated by experts in manufacturing and materials science (implied by the nature of the tests).",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "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": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a thermoplastic for patient stabilization, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with or without AI assistance is not applicable.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Substantial equivalence was established by comparing the device's chemical composition, manufacturing method, physical appearance, physical characteristics (mass density, radiation transmission, bolus effect, moldability, shrinkage), and intended use to a legally marketed predicate device (Aquaplast™ Thermoplastic). The 'ground truth' is the known characteristics and successful use case history of the predicate device itself, along with the results of physical testing on the Klarity™ material.",
  "8. The sample size for the training set": "Not applicable. This is not an AI/ML device that requires a training set of data.",
  "9. How the ground truth for the training set was established": "Not applicable."
}

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