(240 days)
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).
| Acceptance Criteria (based on Predicate Device Characteristics) | Reported Device Performance (Claimed by MacroMedics) |
|---|---|
| Vacuum Cushions: Equivalent design, construction materials, and functionality to MEDTEC, Inc. (CIVCO Medical Solutions and CIVCO Radiotherapy) Vac-Lok cushions. Made of Polystyrene Beads in Polyurethane-coated Nylon bag with a vacuum valve. | Vacuum Cushions: "The designs of the MacroMedics and predicate device are equivalent in shape, construction, materials and functionality. Both [predicate] devices and the MacroMedics devices are made out of Polystyrene Beads in Polyurethane-coated Nylon bag, and feature a valve for creating the vacuum." |
| "MacroMedics claims the proposed VacuumCushions to be substantially equivalent... because the proposed devices have equivalent designs, intended uses, target populations and used materials." | |
| FeetSupports: Equivalent shape, construction materials, and functionality as MacroMedics BV's own previously cleared LEPS and FeetSupports devices. | FeetSupports: "The designs of the MacroMedics subjective device (the Feetsupports which are part of the LEPS), and predicate device are equivalent in shape, construction materials and functionality." |
| "MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population and used materials." | |
| LEPS (Lower Extremities Positioning System): Equivalent shape, construction materials, and functionality as MacroMedics BV's own previously cleared LEPS and FeetSupports devices, and made of the same materials. | LEPS: "The designs of the MacroMedics subjective device and predicate device are equivalent in shape, construction materials and functionality. The MacroMedics predicate device and the subject device are made out of the same materials." |
| "MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population and used materials." | |
| CouchStrips: Equivalent shape, construction materials, and functionality as MacroMedics BV's own previously cleared CouchStrips. | CouchStrips: "The designs of the MacroMedics subjective device and predicate device are equivalent in shape. construction materials and functionality." |
| "MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population and used materials." |
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.