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510(k) Data Aggregation
(211 days)
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.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance |
|---|---|
| Equivalent Intended Use/Indications for Use: The device must have the same or similar intended use as the predicate device. | "Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated." This is identical to the stated indications for use for all predicate devices referenced. |
| Equivalent Design: The device's design must be similar to the predicate device. | "The designs of the MacroMedics and predicate [system type] positioning systems are equivalent in shape, construction, materials and functionality." (Stated for Head and Neck, Lung and Thorax, Pelvic and Lower Extremities, and Thermoplastic systems). "The designs of the MacroMedics and predicate SBRT positioning systems are equivalent in construction, accessories, materials and functionality." |
| Equivalent Construction Materials: The materials used must be similar or new materials must be demonstrated to be equally safe and effective. | Comparisons are made (e.g., carbon fiber, PE foam, acrylic for head and neck; carbon fiber with plastic, aluminum, foam for lung and thorax; carbon fiber with plastic and foam for pelvic; thermoplastics for thermoplastic systems). For new materials like glass fiber (for MR extensions) and PU-foam (for headsupports), biocompatibility and MR safety are explicitly stated as having been "described in this 510(k)." MacroMedics CouchStrips are described as having "almost identical dimensions and materials" to CIVCO LokBars, with a carbon fiber alternative added. |
| Equivalent Functionality: The device must perform its function similarly to the predicate. | "Both the Sinmed devices and the MacroMedics devices are made out of carbon fiber, PE foam and acrylic." (Head and Neck) "Both the predicate and the MacroMedics SBRT devices are made out of carbon fiber baseplates with bridges of plastic..." (SBRT systems) "Both the predicate and the MacroMedics masks are made out of thermoplastics which are cut in shape and glued or welded into plastic injection moulded profiles." (Thermoplastic systems) |
| Equivalent Target Population: The device should be used for the same patient population. | "equivalent designs, intended uses, target population, patient positioning and used materials." (Repeated across all summaries). |
| Similar Position and Immobilization Characteristics: Even with small technological differences, the core function of patient positioning and immobilization must be consistent. | "Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radiodiagnostics." (Repeated across all summaries). |
| MR Safety where indicated: For devices claimed to be MR-safe, this must be demonstrated. | For MR-safe alternatives, the material (e.g., glass fiber) is specifically mentioned, and it's stated that "both the biocompatibility and the MR safety of these new materials have been described in this 510(k)." The design also incorporates features (e.g., 3Pin slots for MR safe CouchStrip, and incompatibility with MR unsafe CouchStrips) intended to prevent incorrect usage in MR environments. |
| Biocompatibility of new materials: Any new materials must be biocompatible. | Explicitly stated for new materials like glass fiber and PU-foam ("both the biocompatibility and the MR safety of these new materials have been described in this 510(k)."). |
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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