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The EleGARD™ Patient Positioning System is cardiopulmonary board which may elevate a patient's head and thorax including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS Chest Compression Systems; and patient transport.

The EleGARD™ patient positioning system is an electrically powered device on which a patient is placed. It can be used to elevate a patient's head and thorax during a number of different procedures, e.g., airway management and different CPR techniques.

The EleGARD™ acts as a back board for airway management and for performing CPR. It allows the user to position the patient in supine or with the head and thorax elevated. The EleGARD™ is a cardiopulmonary back board which is placed under the patient.

It may be used with the patient lying flat or may elevate the patient's thorax and head. The device would be used in emergency conditions when healthcare professionals need to: provide airway management, perform CPR with manual / hand compressions, adjunctive manual CPR devices, and a LUCAS mechanical compression device, perform manual bag / mask ventilation, and transport a patient.

The provided document describes the EleGARD™ Patient Positioning System, a cardiopulmonary board, and its 510(k) submission for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device and outlines various performance tests conducted.

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

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

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

The document does not specify sample sizes for any of the tests. The studies conducted are primarily bench testing and evaluations against recognized standards (e.g., ISO, IEC). There is no mention of patient data (retrospective or prospective) being used in these performance tests. The provenance of any data beyond the specific test standards and internal evaluations is not detailed.

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

This information is not provided in the document. The performance data described relates to engineering and material testing standards, not clinical evaluation requiring expert consensus on ground truth.

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

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth, which is not the type of study detailed here.

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 was not done. This type of study is focused on evaluating the performance of diagnostic algorithms, often with AI assistance, in a clinical setting involving human readers and interpretation of images/data. The EleGARD™ is a patient positioning system, and its evaluation focuses on mechanical, electrical, and material safety and functionality, not diagnostic accuracy or AI assistance for human readers.

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

This is not applicable as the EleGARD™ Patient Positioning System is a physical medical device, not an algorithm that performs a diagnostic or analytical function. Therefore, a standalone algorithm performance study was not conducted.

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

For the engineering and material safety tests described, the "ground truth" is established by adherence to the specified international and national standards (e.g., ISO 10993-1, ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-12). Compliance with these standards serves as the benchmark for acceptable performance. There is no mention of clinical outcomes data, expert consensus, or pathological findings being used as ground truth for these studies.

8. The sample size for the training set

This is not applicable. The EleGARD™ is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable for the same reasons above; there is no training set for this type of device.

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The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.

The Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.

The requested information is contained within the provided text. The device in question is the "Z-Robot™ Patient Positioning System", which is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a "table of acceptance criteria and reported device performance" for all tests. However, it lists the performance parameters tested and indicates that "All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report." It also provides a direct comparison to the predicate device for several key performance metrics, implying these are the relevant acceptance criteria for substantial equivalence.

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The patient positioning system is a SCARA designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for a device called "Patient Positioning System" by Forte Automation Systems, Inc. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide a response to your request, as the necessary information is not present in the provided text.

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CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.

The CDR Systems Precision Patient Positioning System consists of several options that may be purchased individually or as a complete system.

1. The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is manufactured from Vinvl skinned flexible polyurethane foam and carbon fiber/epoxy components.
2. The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
3. The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
4. The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
5. The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
6. The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
7. The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
8. The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.

The provided text is a 510(k) summary for the CDR Systems Precision Patient Positioning System, a medical device used to position patients for radiation therapy. This document primarily focuses on establishing "substantial equivalence" to predicate devices based on intended use and technological characteristics, particularly beam attenuation.

Crucially, this document does NOT contain information about a study proving the device meets acceptance criteria related to AI or a "human-in-the-loop" performance study. The device described is a physical patient positioning system, not an AI software or a device that would require such studies for its performance. The "performance testing" mentioned is "Bench (Tab 12) indicates that CDR devices attenuate a 6 MeV radiation beam by less than 3%." This is the only direct performance metric stated.

Therefore, I cannot provide details on the following as they are not present in the provided text:

• A table of acceptance criteria for AI performance and reported device performance.
• Sample size used for an AI test set or data provenance.
• Number of experts used to establish ground truth for an AI test set or their qualifications.
• Adjudication method for an AI test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used for AI (expert consensus, pathology, outcomes data, etc.).
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

**Based on the provided text, the only "acceptance criteria" discussed are related to the device's physical properties and its substantial equivalence to predicate devices, specifically:

1. Acceptance Criteria and Reported Device Performance (as stated for this physical device):

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

• Sample Size: Not applicable in the context of AI or clinical performance for this physical device as described. The "performance testing" cited refers to bench testing (attenuation of a radiation beam), not a study with a "test set" of patient data.
• Data Provenance: Not applicable. The performance data is from laboratory/bench testing of materials, not patient data.

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

• Not applicable. Ground truth for an AI model is not relevant here as this is a physical medical device.

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:

• Not applicable. This device is not an AI system.

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

• Not applicable. This device is not an AI system or an algorithm.

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

• Not applicable. The performance evaluation here is based on physical properties (beam attenuation) measured through bench testing against a specified threshold.

8. The sample size for the training set:

• Not applicable. There is no training set for a physical patient positioning device.

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

• Not applicable.

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The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

The patient positioning system is a SCARA designed robotic arm allowing six degrees of freedom.

The provided 510(k) summary for the Forte Automation Systems Patient Positioning System (K122413) does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

This 510(k) pertains to a patient positioning system, which is a robotic arm for positioning patients during medical procedures. The submission focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device. Clinical efficacy or diagnostic performance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and a clinical study to prove them, are not applicable to this type of device submission.

Here's a breakdown of the available information based on your requested points, highlighting why some are not present for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

It's crucial to understand that these are engineering/safety performance criteria, not clinical performance criteria in the context of diagnostic devices. The document states, "The submitted device does not impart energies into a patient. Therefore no clinical testing was needed." This confirms that the 510(k) submission relies on non-clinical engineering and safety performance to demonstrate substantial 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. The tests conducted were non-clinical engineering tests (e.g., electromagnetic compatibility, vibration, speed, accuracy, collision detection) on the device itself, not on a patient population. There is no "test set" of patient data.

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, in the context of clinical or diagnostic performance, is established by experts (e.g., radiologists, pathologists). Since no clinical testing was performed and no patient data was analyzed, this information is not relevant to this 510(k) submission.

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

Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of clinical or diagnostic data. This was not part of the non-clinical testing performed.

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. MRMC studies are used to assess the clinical effectiveness of diagnostic devices and often involve human readers interpreting medical images. This device is a patient positioning system, not an imaging or diagnostic device with AI assistance.

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

Not applicable. Standalone performance refers to the diagnostic accuracy of an algorithm without human intervention. This is not a diagnostic algorithm. The "performance" discussed for this device relates to its mechanical and electrical functions.

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

For the non-clinical tests, the "ground truth" was established by engineering specifications, industry standards, and the physical properties of the device. For example, the accuracy tests would compare the device's measured positioning to its programmed target position, with "ground truth" being the theoretically correct position based on the design.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" for model development.

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

Not applicable, as there is no training set for this device.

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The Bionix Pelvis BellyBoard PLUS patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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.

The Bionix SecureVac patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning 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.

The Bionix SecureFoam patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning 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.

The Bionix SecureFit Bar patient positioning device developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning 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.

The Bionix Extended Butterfly Armboard patient positioning device, developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning 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.

The Pelvis BellyBoard PLUS from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy. The Bionix Pelvis BellyBoard PLUS is flat and has a similar, generally rounded rectangular-shaped contour, with areas specifically designed for the head, abdomen, and thighs. Specially designed cushions that fit in these areas of the Pelvis BellyBoard PLUS are used to position and support the patient. The head cushion has a contoured opening so that the patient may rest his/her head comfortably in the prone position during the treatment process. The abdominal cushion is also designed with an open, contoured cutout region. The patient is positioned over the abdominal cushion such that the belly drops into the cutout region during the radiation therapy session. Contoured thigh cushions are provided for patient comfort and support. The cushions are affixed to the thermoplastic shell of the Pelvis BellyBoard PLUS using Velcro strips in the usual fashion. The Bionix Pelvis BellyBoard PLUS is constructed in a manner similar to the Advanced Belly board System from Med-Tec, having a thermoformed thermoplastic Kydex® shell with an air core that is an accepted standard in radiation therapy. The thermoformed Kydex® shell again provides stiffness and strength, while the air core allows for almost no attenuation of the radiation beam during the treatment process. The Pelvis BellyBoard PLUS also has simple mechanical interlocks that allow the board to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow lowmelt thermoplastic to be attached to the Pelvis BellyBoard PLUS during the patient positioning process.

The SecureVac Immobilization System from Bionix Development Corporation is designed to be used for the positioning and repositioning of patients for receiving radiation therapy. The SecureVac bags are constructed from strong, vinyl coated nylon material that is filled with small polystyrene spheres to immobilize the patient. Each bag is double sealed airtight and fitted with a self-closing valve for ease of use. It also features a pinch clamp system for more security. Once evacuated, the Secure Vac cushion holds a rigid shape over the course of the radiation therapy treatment regimen. The Bionix SecureVac Immobilization System is constructed in a manner similar to the Vac-Lok Immobilization System from Med-Tec, having a plastic nylon/vinyl film skin and filled with small polystyrene beads. The bag is sealed to be airtight, and an integral check valve is used to deflate and re-inflate the bag, and to maintain the bag in an evacuated state.

The SecureFoam from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy. The Bionix SecureFoam is a two-part foaming system comprised of Part B (polyol) and Part A (diisocyanate) components. The reaction of the polyol and diisocyanate components produces a water-blown polyurethane foam that hardens to rigidity as it cures. The polyurethane foam produced by this process is mostly air-filled, and thus has an air-equivalent radiolucency similar to that of the Med-Tec RediFoam.

The SecureFit Bar from Bionix Development Corporation is designed to be used for the indexing of patient immobilization devices to a treatment couch top. The Bionix SecureFit Bar is comprised of either aluminum or a rigid carbon fiber/epoxy laminate material. The SecureFit Bar has an engagement pin on one end and a cam-type pivot on its other end that allows it to lock into these indentations and securely hold the bar in position on the treatment couch top. Locator pins on the SecureFit Bar engage matching openings on the underside of the immobilization device, in this case the Bionix Pelvis BellyBoard PLUS, allowing the immobilization device to be reproducibly indexed to the treatment couch top.

The Extended Butterfly Armboard from Bionix Development Corporation is designed to be used for the positioning and repositioning of patients for receiving radiation therapy. The Bionix Extended Butterfly Armboard is constructed of a single piece of polycarbonate plastic material that is machined and thermoformed to achieve the final product design. The Extended Butterfly Board has elevated thermoformed "wings" on either side to support the patient's upper arms and facilitate patient positioning and comfort. An adjustable T-Bar handgrip is attached to the board. The T-Bar handgrip adjusts in both the horizontal and vertical direction to facilitate patient positioning and repositioning. Various headrests and cushions may be used to assist in patient positioning and improve patient comfort. The Bionix Extended Butterfly Armboard may be used alone or in conjunction with other patient positioning devices such as the Bionix Pelvis BellyBoard.

The provided document is a 510(k) Premarket Notification submission for the Pelvis BellyBoard PLUS and accessory products. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a study proving the device meets specific performance acceptance criteria.

The document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or ground truth establishment for a test set.
• Number of experts or their qualifications, or adjudication methods for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Sample size for a training set or how ground truth for a training set was established.

Instead, the submission relies on the concept of substantial equivalence. It argues that the Bionix devices (Pelvis BellyBoard PLUS, SecureVac System, SecureFoam System, SecureFit Bar, Extended Butterfly Armboard) are so similar in design, construction, function, and intended use to existing, legally marketed predicate devices that they should be considered substantially equivalent.

The "study" that proves the device meets the acceptance criteria (interpreted here as demonstrating substantial equivalence) is the comparison presented in the 510(k) submission itself.

Here's a breakdown of the claims of substantial equivalence for each product:

1. Pelvis BellyBoard PLUS

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness, support strength, and minimal attenuation of the radiotherapy beam as the predicate devices, and function in a clinically identical fashion.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Devices:
    • Med-Tec Advanced Belly board System (K023293): Thermoformed plastic shell with a foam core, generally rectangular, specific areas for head, abdominal, and leg cushions (Velcro affixed), mechanical interlocking for couch attachment and low-melt thermoplastic masks. Minimal attenuation due to foam core (mostly air).
    • AccuFix IMRT Quick-fix Carbon Fiber Pelvis System (WFR/Aquaplast Corp.): Carbon fiber/epoxy skin with a foam core, provides strength, stiffness, and minimal attenuation. Can be indexed to treatment tabletops, used with low-melt thermoplastic for positioning.
  • Bionix Pelvis BellyBoard PLUS: Flat, similar rounded rectangular contour, areas for head, abdomen, thighs. Specially designed cushions (Velcro affixed), head cushion with contoured opening, abdominal cushion with open contoured cutout. Constructed with thermoformed Kydex® shell with an air core, providing stiffness, strength, and almost no radiation beam attenuation. Simple mechanical interlocks for couch attachment and low-melt thermoplastic. Can be used prone (with belly falling into cutout) or supine (with standard or custom SecureVac/SecureFoam cushions).
• Conclusion of Substantial Equivalence: Based on almost identical design, construction, and function to the Med-Tec Advanced Belly board System and similar design and intended use to the AccuFix IMRT Quick-fix Carbon Fiber Pelvis System, it is "reasonable to expect" similar properties (stiffness, support strength, minimal attenuation) and clinically identical function.

2. SecureVac System

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties and attenuation factors as the predicate devices, and function in a clinically identical fashion for patient positioning and repositioning.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Devices:
    • Med-Tec Vac-Lok System (K935300): Nylon-reinforced blue urethane bags filled with tiny polystyrene beads, airtight, closeable check valve. Air-equivalent radiolucency. Bags are evacuated to conform to anatomy, forming a rigid, re-positionable mold.
    • S&S Par Scientific Vac Fix System (K895697): Urethane film bag filled with polystyrene beads, check valve, airtight. Functions by evacuation to conform to patient anatomy.
  • Bionix SecureVac Immobilization System: Constructed from strong, vinyl-coated nylon material filled with small polystyrene spheres. Double-sealed airtight, self-closing valve, pinch clamp system for security. Evacuated bags form a rigid shape conforming to patient anatomy for re-positioning.
• Conclusion of Substantial Equivalence: Based on almost identical design, construction, and function to the Med-Tec Vac-Lok Immobilization System and the S&S Par Scientific Vac Fix System, it is "reasonable to expect" similar properties and attenuation factors, and clinically identical function.

3. SecureFoam System

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties and attenuation factors as the predicate devices, and function in a clinically identical fashion for patient positioning and repositioning.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Devices:
    • Med-Tec RediFoam (K951808): Two-part foaming agent (diisocyanate and polyol) reacting to form water-blown polyurethane foam. Mostly air-filled, effectively air-equivalent for minimal attenuation. Poured into a plastic bag, placed on immobilization device, expands around patient, cures to rigid, re-positionable mold.
    • Soule, Inc. Rapid-Foam (K952457): Two-part foaming agent (diisocyanate and polyol) reacting to form water-blown rigid polyurethane foam. Mostly air-filled, air-equivalent radiolucency. Functions by expanding around patient and curing to a rigid, re-positionable mold conforming to patient and immobilization device.
  • Bionix SecureFoam: Two-part foaming system (Part B polyol, Part A diisocyanate) reacting to produce water-blown polyurethane foam. Hardens to rigidity, mostly air-filled, air-equivalent radiolucency similar to Med-Tec RediFoam. Used in the same fashion as predicate devices: reacted components poured into a plastic bag, placed over patient immobilization device (e.g., Pelvis BellyBoard PLUS), expands around patient, rapidly cures to rigidity, forming a custom, re-positionable mold.
• Conclusion of Substantial Equivalence: Based on almost identical composition and mixing process to the Med-Tec RediFoam and Soule, Inc. Rapid-Foam, it is "reasonable to expect" similar properties and attenuation factors, and clinically identical function.

4. SecureFit Bar

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness and support strength as the predicate devices, and function in a clinically identical fashion for indexing patient immobilization devices.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Device:
    • Med-Tec Exact Lok-Bar (K973842): Rigid aluminum bar machined to couch width, engagement pins on underside for couch indentations. Cam-like pivot for tightening to couch. Locator pins on surface for corresponding holes on immobilization device. Not intended to be radiolucent as it's outside the treatment field.
  • Bionix SecureFit Bar: Comprised of either aluminum or rigid carbon fiber/epoxy laminate material. Engagement pin on one end and cam-type pivot on other end for locking into couch indentations. Locator pins engage matching openings on the underside of immobilization devices (e.g., Pelvis BellyBoard PLUS) for reproducible indexing.
• Conclusion of Substantial Equivalence: Based on almost identical design and construction to the Med-Tec Exact Lok-Bar, it is "reasonable to expect" similar properties (stiffness, support strength) and clinically identical function for reproductively indexing immobilization devices.

5. Extended Butterfly Armboard

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness, support strength, and minimal attenuation of the radiotherapy beam as the predicate device (when positioned flat), and function in a clinically identical fashion.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Device:
    • Med-Tec MT-200 Acrylic Breastboard (K935412): Two pieces of machined acrylic plastic hinged to form a device. Upper piece for patient support (can be angled), lower piece as base. Notched rod for angle adjustment. Threaded rods serve as adjustable handgrips to elevate arms out of the treatment field. Used with cushions/headrests for comfort.
  • Bionix Extended Butterfly Armboard: Single piece of machined and thermoformed polycarbonate plastic. Elevated thermoformed "wings" to support upper arms. Adjustable T-Bar handgrip (horizontal and vertical adjustment) for patient positioning and repositioning, to keep arms elevated. Can use various headrests/cushions. Mounting holes for use with other devices.
• Conclusion of Substantial Equivalence: Based on similar design, composition, and construction to the Med-Tec MT-200 Acrylic Breastboard (specifically when the predicate is in the flat, true supine position), it is "reasonable to expect" similar properties (stiffness, support strength, minimal attenuation) and clinically identical function.

In summary, the "study" for these devices is the detailed comparison to predicate devices, asserting that the new devices share fundamental technological characteristics and intended use, and therefore can be expected to perform equivalently. No experimental studies with specific acceptance criteria, sample sizes, expert ground truth, or MRMC/standalone performance data are presented in this 510(k) submission.

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This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures.

The ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.

The provided text is a 510(k) clearance letter from the FDA for the BrainLAB ExacTrac Patient Positioning System. It ays that the device is substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain the acceptance criteria or the details of any study used to prove the device meets acceptance criteria.

The 510(k) clearance process primarily establishes substantial equivalence to a predicate device, rather than requiring extensive performance studies with defined acceptance criteria in the same way a Premarket Approval (PMA) would. While the applicant would have submitted data demonstrating the device's performance, these specific details (acceptance criteria, study design, sample size, ground truth, expert qualifications, etc.) are generally described in the 510(k) summary and full submission, not in the clearance letter itself.

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

To answer your questions, I would need access to the actual 510(k) summary document (K983660) for the ExacTrac system, which would likely contain the performance data and testing details.

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The RadioCameras™ System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The RadioCameras™ System uses optical tracking of infrared markers as the method of locating the position of the patient. The RadioCameras™ System consists of a high resolution linear CCD camera array, computer workstation, an optical Positioner, and an optical calibration jig.

The provided text is a 510(k) summary and an FDA clearance letter for the RadioCameras™ Patient Positioning System. It describes the device's purpose and general claims of substantial equivalence butdoes not contain any information about acceptance criteria, specific performance metrics, or details of a study demonstrating its performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states that the device "was shown to be substantially equivalent to other commercially available patient positioning systems" for its intended use, which is general information about regulatory clearance rather than a detailed performance study.

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