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All devices apart from Handgrips HNS, set/2 (111730):

Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment.

Handgrips HNS, set/2 (111730):

Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch strips. A Coil Reference Tool accessory is available.

The DSPS-Prominent baseplate supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch using couch strips. Optional accessory hand grips are available.

The DSPS-Prominent cradles support the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The devices feature a cantilevered frame which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is required to be fixed to a baseplate.

The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used together with a DSPS-Prominent baseplate or cradle to facilitate accurate positioning and immobilization of the head and neck or head, neck and shoulder region of the patient. The Masks which do not support the positioning of the shoulders are termed 'head only' masks. Shoulder Profile and Shim accessories are available.

The provided document does not detail specific acceptance criteria or an associated study with quantitative results for the device's performance against said criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, technological characteristics, and indications for use.

The document states:

• "Non-clinical performance testing was completed to ensure that the devices fulfilled the defined requirements."
• "Clinical testing was performed to ensure that the use of the devices supports the achievement of submillimeter positional accuracy."
• "In addition, attenuation measurements were taken, and water equivalence measurements were calculated, for the devices."
• "The testing confirmed that the new devices are as safe and effective as the predicate devices."

However, it lacks the specific numerical acceptance criteria for these tests (e.g., "positional accuracy must be within X mm") and the reported performance values from these tests. It also does not provide details on the study design for the "non-clinical performance testing" or "clinical testing," such as sample size, ground truth establishment, expert qualifications, or adjudication methods.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This information is not present in the provided text.

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DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR:

Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.

CouchStrip:

Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

DSPS-Prominent Masks: The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used as part of the DSPS-Prominent system to facilitate accurate positioning and immobilization of the head, neck and shoulder region of the patient.

DSPS-Prominent™ Baseplate, MR: The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks. The device is fixed to the couch using couch strips.

CouchStrip: CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. The DSPS-Prominent CouchStrip is MR Safe.

This document describes a 510(k) premarket notification for patient positioning devices (DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR, CouchStrip). This submission is for medical devices, specifically for radiotherapy positioning and immobilization, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance (e.g., sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and functionality, rather than presenting performance metrics against specific acceptance criteria for an AI algorithm.

The "Testing Performed" section broadly states:

• "Clinical and non-clinical testing was performed."
• "Non-clinical performance testing was completed to ensure that the devices fulfilled the defined requirements."
• "Clinical testing was performed to ensure that the use of the devices enables submillimetre positional accuracy to be achieved."
• "The testing confirmed that the new devices are as safe and effective as the predicate devices."

However, specific acceptance criteria and detailed quantitative results from these tests are not provided in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions related to AI/ML study design, as this information is not present in the provided text.

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The FlexBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.

The EagleBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.

The BreastBoard SX™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.

The FlexBoard™ base is a lightweight baseplate with a locking system specially designed to host multiple types of breast treatment modules, in order to facilitate the positioning of the patient for breast and chest treatments. Multiple variants of FlexBoard™ breast treatment modules are available. To enable enhanced treatment possibilities, the 122930 EagleBoard™-2 Base device can be used with the 172120 FlexBoard™ BTM-EX breast module as part of the FlexBoard™ setup.

The EagleBoard™ devices consist of baseplates with a tapered design, and accessories, such as hand grips, which can be used together to support the positioning of the patient for breast and chest treatments. The 122930 EagleBoard™-2 Base device can be utilized both as part of a FlexBoard™ setup, or individually on the treatment table. The 122950 EagleBoard™-2 Base, MR and 122850 EagleBoard™ MR devices are intended to be utilized individually on the treatment table.

The BreastBoard SX™ is a lightweight baseplate designed to facilitate the positioning of patients for breast and chest treatments. The BreastBoard SX™ is adjustable and can be secured at various tilt positions. It features an adjustable bottom-stop, arm support possibilities for positioning the patient's arms above their head, place for a head rest, and fixation points for thermoplastic masks.

The provided text is a 510(k) summary for patient positioning devices (FlexBoard, EagleBoard, BreastBoard SX). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone performance study with a test set, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, studies proving the device meets them, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

The document primarily states:

• Performance Data: "Mechanical non-clinical testing and other performance data demonstrated that the devices performed as intended and that the differences in technological characteristics did not raise any new issues of safety or effectiveness." This is a general statement and does not provide specific acceptance criteria or detailed study results.
• Substantial Equivalence: The core argument is that the proposed devices have equivalent designs and intended uses to previously cleared predicate devices.

Without more detailed performance study reports, it's impossible to fill out the requested table or describe the specific study methodologies outlined in your prompt.

Here's why the requested information is missing based on the document:

• Nature of the Submission: This is a 510(k) premarket notification. For Class II devices like these, the primary mechanism for clearance is often demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new, de novo clinical trials to establish efficacy and safety against predefined performance criteria in the way a novel AI or diagnostic device might.
• Device Type: Patient positioning devices are mechanical aids. Their safety and effectiveness are typically demonstrated through engineering analyses (e.g., strength, durability, material compatibility), dimensional comparisons, and ensuring they don't introduce new risks compared to existing devices. They are not diagnostic or AI-driven tools that would require complex performance metrics like sensitivity, specificity, or reader studies.

If this were a diagnostic or AI-enabled device, the provided information would be insufficient for FDA clearance, and the kind of detailed performance data you're asking for would be mandatory. However, for a patient positioning device, the level of evidence presented (mechanical non-clinical testing and comparison to predicates) is considered adequate for a 510(k) pathway.

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Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

The VacuumCushions (Vacuum Cushions) are cushions which are formed around the patient to create a rigid impression of the patient's anatomy in order to facilitate reproducible positioning. The impression is created through drawing the air out of the cushion whilst the patient is in the desired position.

The FeetSupports facilitate the positioning of the patient's feet. They are available in fixed and rotatable variants and can be fixed to various baseplates and couchtops.

The LEPS enables a patient's lower extremities to be positioned, using a Kneesupport, FeetSupport and, as desired, a LiftBlock. Shoulder Retractors can also be used to support the retraction of the patient's shoulders. The base of the LEPS is the LEPS baseplate. The LEPS Short baseplate enables the patient's feet to be positioned using a FeetSupport. The LEPS baseplates can be positioned on the couch treatment table using couch strips.

CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. Depending on the indexing system of the treatment table, its width, the preference in transverse adjustability and required MR safety, different types and indexing styles are available. VacuumCushion Positioning Strips (VCPS) are CouchStrips which are placed onto other CouchStrips in order to secure a VacuumCushion in place.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device performance, specifically for an AI/device related to medical imaging.

However, it's crucial to understand a key limitation:

The provided text, a 510(k) submission for MacroMedics BV, describes patient positioning devices (Vacuum Cushions, FeetSupports, LEPS, CouchStrips) used in radiotherapy and radiodiagnostics. These are physical devices, not AI-powered software or diagnostic tools.

Therefore, most of the points in your request, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e., algorithm only without human-in-the-loop performance)," "sample size for training set," and "ground truth for training set," are not applicable to this type of device and submission.

A 510(k) submission for physical devices primarily focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving novel performance against a clinical ground truth using statistical studies in the same way an AI/software device would.

Despite this, I will extract and interpret the relevant information as best as possible within the context of a physical device submission:

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

For a physical device demonstrating substantial equivalence, the "acceptance criteria" are typically the characteristics of the predicate device, and the "reported device performance" is the demonstration that the new device shares those characteristics. It's not about quantitative performance metrics in the way you'd see for an AI algorithm (e.g., sensitivity, specificity).

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. For this type of physical device 510(k), there isn't a "test set" of patient data in the way there would be for an AI diagnostic device. The "test" is a comparison of the new device's engineering specifications and performance to the predicate device's, often through bench testing or design verification rather than a clinical study with patient samples. The submission highlights equivalence in design, materials, and intended use.

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. As there's no "test set" of clinical data requiring expert review to establish ground truth for a diagnostic outcome, this information is not relevant to this submission.

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

• Not Applicable. No clinical test set requiring adjudication of findings.

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 is specific to AI-assisted diagnostic tools. The devices are patient positioning equipment, not AI software.

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

• Not Applicable. This is specific to AI algorithms.

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

• Not Applicable (in the diagnostic sense). The "ground truth" for this submission is effectively the established safety and effectiveness profile of the predicate devices. The new devices demonstrate substantial equivalence by matching the predicate's characteristics (materials, design, function, intended use), implying they would have the same safety and effectiveness.

8. The sample size for the training set

• Not Applicable. There is no "training set" for physical patient positioning devices because they do not involve machine learning or data-driven model training.

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

• Not Applicable. As there is no training set, this is not relevant.

In summary of the provided document:

The 510(k) submission for MacroMedics BV's patient positioning devices (Vacuum Cushions, FeetSupports, LEPS, CouchStrips) is a substantial equivalence claim. The "acceptance criteria" and "proof of meeting criteria" are demonstrated by showing that the new devices are equivalent in design, materials, intended use, target population, and functionality to previously cleared predicate devices. This type of submission does not involve clinical studies with patient data, AI algorithms, or the evaluation of human reader performance with or without AI assistance, which are typical requirements for AI/diagnostic software.

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Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

Baseplates and headsupports which are designed to position the head and neck and on which thermoplastic masks can be attached to fix the head and neck of the patient. Baseplates can be positioned on the couch using CouchStrips. The ExaFix-IMRT baseplates are attached onto the couches and extent the head of the patient from the couch at the cranial side. Various accessories offered for specific patient head and neck set-ups. The different headsupports are designed for different head positions. Different blocks are available for lifting the head, wedges and ExaTilt to incline the head. For the Exafix-5 baseplate an acrylic alternative (Exafix-5a) is available for identical head- and neck positioning in the MR environment. For the IMRT baseplates a glassfiber alternative (Exafix IMRT baseplate MR) is available for identical head- and neck positioning in MR environment. The MR safe devices have a 3Pin slot on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment.

The BreastBoard LX and ThoraxSupports are devices which position the breast and lung area of a patient. The arms are placed above the head and a headsupport can be placed into the baseplate. The backsupport of the BreastBoard LX can be tilted, to tilt the upperpart of the patient´s body for other treatment possibilities. The ThoraxSupport does not have this tilting possibility. Various accessories are provided for positioning of the arms or the thorax. For the ThoraxSupport a glassfiber MR alternative (Thoraxsupport MR) is available for identical lung and thorax positioning in MR environment. The MR safe device has a 3Pin slot on the bottomside and is compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment.

Baseplates which are designed to position the pelvic or (lower) extremities of a patient. The Pelvic Prone Board positions the patient in prone position with the arms in cranial direction, belly is placed in an aperture. The shape of the pelvic prone board moves the small bowel and reduces the irradiated small bowel volume while treating the lower abdomen. The LEPS position the legs on a KneeSupport which can be tilted and the feet are positioned in a FeetSupport. Both baseplates can be positioned on the couch using fixation rails. For the Pelvic Prone Board a glassfiber MR alternative (Pelvic Prone Board MR) is available for identical positioning in MR environment. The LEPS is a MR safe device. The MR safe devices have 3Pin slots on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe device is not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment.

The SBRT systems (Stereotactic Body Radiation Therapy Systems) are devices which can position various bodyparts of the patient. The MacroMedics SBRT systems are carbon fiber baseplates over which various plastic bridges can be placed with attached accessories to position the patient's body. The SBRT OmniBoard does have an inclination possibility of the upper body. The accessories are identical, but the baseboards are different, each baseboard has slightly different features for customer preferences. The patient set-up is similar on all boards, supine position with the arms mainly positioned above the patient's head. Bottom, knees and feet positioned in indexed positions. Vacuumcushions are used for positioning by moulding the cushion around the patients and then take the air out with a vacuumpump. The contrashape of the patient stays in the cushion during the treatment. CouchStrips are strips which connect the patient positioning device onto the couch at indexed positions. Depending on the indexing system of the couch, width of the couch, preference in transverse adjustability and required MR safety different types are available. The SBRT carbon fiber baseplates are MR unsafe and have a 2Pin CouchStrip slot. They are not compatible with the 3Pin MR CouchStrip, which prevents the use in the wrong environment. The CouchStrips for MR are made out of MR safe materials and have 3pins. MR unsafe devices have a 2Pin CouchStrip slot on the bottomside and are not compatible with this 3Pin MR CouchStrip. The Vacuumcushions are MR safe.

MacroMedics thermoplastic masks are developed in order to position the individual patient. The thermoplastic masks are placed in a waterbath of about 70 degrees where they become flexible. After drying and cooling, they make a perfect contramould of the bodypart which needs to be positioned. Plastic profiles attach the mask onto the baseplate. Masks and profiles are available in many different shapes, in order to fit on different baseplates and bodyparts. DSPS offers a possibility to create a thermoplastic mask for both occipital- and facial areas for extra accurate positioning. Both masks are attached onto the DSPS cradle, and the DSPS cradle is attached onto the baseplate. MacroMedics thermoplastic masks with plastic profiles are MR safe.

This document describes a 510(k) premarket notification for "Patient Positioning Devices" by MacroMedics BV. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The acceptance criteria and the study that proves the device meets them are based on this claim of substantial equivalence.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet. Instead, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The reported device performance is a direct comparison of technological characteristics and intended use.

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

This is a design and feature comparison study, not a clinical or performance study with a "test set" in the sense of patient data. The "sample" here comprises the various devices produced by MacroMedics (ExaFix-5, ExaTilt, BreastBoard LX, SBRT EAMIS, etc.) and their respective predicate devices.

• Sample Size: Not applicable in the context of statistical sampling for a test set. All relevant MacroMedics devices for each category (Head and Neck, Lung and Thorax, Pelvic and Lower Extremities, SBRT, Thermoplastic) were compared against their identified predicate devices.
• Data Provenance: This is not a study involving patient data. The "data" are the specifications, designs, and material descriptions of the MacroMedics devices and the predicate devices. This information would be derived from internal engineering documents for the MacroMedics devices and publicly available or predicate device manufacturer information for the predicates. The country of origin for MacroMedics is The Netherlands. The study is a retrospective comparison of device characteristics.

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

Not applicable. "Ground truth" in this context refers to the characteristics and intended use of the predicate devices and the MacroMedics devices. This is established through engineering specifications, material composition, and regulatory filings. It does not require expert consensus on a test set of data points. The "experts" involved are the company's R&D, quality, and regulatory teams responsible for designing the device and preparing the 510(k) submission, and potentially an independent review by an MR safety expert or toxicologist if new materials were used and specific test reports were included in the full submission, but this is not detailed in the summary provided.

4. Adjudication Method for the Test Set

Not applicable. There is no test set of results requiring adjudication. The comparison is based on documented specifications and characteristics.

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 physical patient positioning system, not an AI diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is the established safety and effectiveness profile of the predicate devices, as determined by their prior FDA clearance (510(k) numbers are provided). For the MacroMedics devices, the "ground truth" is their design specifications, material composition, and intended function as described by the manufacturer. The comparison aims to show that these characteristics are sufficiently similar or improved without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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