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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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The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Ofix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.

The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Ofix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.

This document is a 510(k) Premarket Notification letter from the FDA regarding the "kVue IGRT Treatment Table Top". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given document.

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The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient's anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient's anatomy. This mold or mask can then be used to minimize patient movement, and accurately reposition the patient for subsequent treatment sessions.

The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient's anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient's anatomy. This mold or mask can then be used to minimize patient movement, and accurately reposition the patient for subsequent treatment sessions.

Based on the provided text, there is no information available regarding acceptance criteria or a study proving that the device meets specific performance criteria. This document is a 510(k) clearance letter from the FDA, which primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than detailed performance evaluations against specific acceptance criteria.

Therefore, I cannot populate the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.
• Sample size for training sets or how ground truth for training was established.

The 510(k) clearance process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and intended use, rather than extensive new clinical trials with detailed performance metrics and acceptance criteria.

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The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attaches to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatment sessions.

The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and Aquaplast RT Thermoplastic (K 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attaches to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the Headholder and a custom fit mask attaches to the Headholder in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent treatment sessions.

The provided documents do not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The documents are a 510(k) clearance letter from the FDA for a device called "AccuFix Tilting Radiotranslucent Headholder". This letter confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.

Key information from the documents:

• Device Name: AccuFix Tilting Radiotranslucent Headholder
• Manufacturer: WFR/AQUAPLAST Corporation
• Regulatory Class: II
• Product Code: 90 IYE
• Indication for Use: To be used with a head rest or prone pillow and Aquaplast RT Thermoplastic masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. Its purpose is to minimize patient head movement and allow for accurate repositioning for subsequent treatment sessions.
• FDA Decision Date: July 2, 2002

Since the documents are a notification of substantial equivalence and not a detailed study report, they do not include the specific technical performance data or study methodologies typically required to answer your questions.

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Dressing for use after intraoral palatal surgery.

PS Thermoplastic (Aquaplast) Palatal Stent

The provided text is a 510(k) clearance letter from the FDA for a device called "Aquaplast Palatal Stent." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

The letter confirms that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This determination of substantial equivalence is based on the device's indications for use and classification, rather than explicit performance metrics from a controlled study described within this document.

Consequently, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria other than "substantial equivalence."
2. Sample size used for the test set and the data provenance: No study data or test set information is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study is detailed.
4. 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: Not applicable. This device is a palatal stent, not an AI-assisted diagnostic tool.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is purely administrative, granting marketing clearance based on a regulatory comparison to existing devices, not on the presentation of new performance study data.

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