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The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.

Device Description

The HP PRO Positioning Device is used by first attaching the base plate to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. An example of an immobilization device is the overlay base plate of the Proton Immobilization Solution.

The HP PRO Positioning Device is a device that assists in the proper positioning and repositioning of patients for radiation therapy and radiosurgery with protons. It is an accessory to the Proton Immobilization Solution. The HP PRO Positioning Device is typically attached to the treatment table and supports the patient during treatment. The proposed HP PRO Positioning Device is essentially an extension of the treatment table.

The HP PRO Positioning Device is made up of 4 components: Base Plate (PMMA and Carbon Fiber), Interface (Aluminum), Indexing Pins (POM (Polyoxymethylene)), and Sheet Screws (Stainless Steel).

AI/ML Overview

The provided document describes the HP PRO Positioning Device and its substantial equivalence to a predicate device, K151207 Proton Immobilization Solution. The study focuses on demonstrating that the new device performs comparably to the predicate device across various physical and dosimetric properties.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria/Requirement	Reported Device Performance (HP PRO Positioning Device)
Physical Properties
Length	Range 45-52"	50.17 inches (within range)
Width	21"	21.61 inches (comparable, deemed SE)
Height	1.9"	1.62 inches (comparable, deemed SE)
Sag at cranial end (135kg distributed load)	2.51 mm (from predicate)	9.21 mm (Predicate: 2.51mm; Device: 9.21mm; Deemed SE, with a note that a 6DOF Robotic patient couch top can compensate for bending effect. Implicit acceptance: Sag + Creep < 25mm.)
Creep at cranial end (135kg, 60 min)	0.0785 mm (from predicate)	0.214 mm (Predicate: 0.0785mm; Device: 0.214mm; Deemed SE, with a note that a 6DOF Robotic patient couch top can compensate for bending effect. Implicit acceptance: Sag + Creep < 25mm.)
Flatness Test	Not explicitly stated for predicate but implied to be acceptable.	$\Delta$ < 1 mm deviation (meets specifications)
Surface Morphology	Visually inspected for polishing, milling, and absence of edge or surface damage or cavities.	Meets specifications.
Dimensions Tolerance	Not explicitly stated as acceptance criteria, but mentioned for performance.	All falling within specifications and tolerance of 0.1 – 0.2mm.
Mechanical Strength (IEC60601-1)
Patient Weight Distribution	Up to 135 kg. Patient lower parts of legs not resting/supported.	Designed for Patients of up to 135 kg. Lower legs not supported (SE to predicate).
Tensile Safety Factor	Safety factor of 6. Patient weight reduced by 14.8% for calculation.	Tensile Safety Factor of 6 (SE to predicate).
Tensile Safety Weight	Device passes total load of 933.65kg for 1 minute when calculated at 85.2% of 135kg.	Device passes total load of 933.65kg for 1 minute (SE to predicate).
Elongation	Elongation of break less than 5%.	Elongation of break < 5% (SE to predicate).
Wear	Device not impaired by wear.	Neither the predicate nor proposed system is impaired by wear (SE to predicate).
Mechanical Strength	Handle a 150kg load for minimum of 1 minute with no deformation or risks.	Both devices can handle a 150kg load for minimum of 1 minute with no deformation or risks (SE to predicate).
Mechanical Strength Sitting	Handle a load of 60% of safe working load (min 80kg) for one minute, center 60mm from outer edge.	Device was tested with 90kg for 1 minute and passed (SE to predicate).
Dynamic Forces	Handle loads with a total mass of 153.3 kg hanging 150mm and dropped on surface.	Both devices can handle loads with a total mass of 153.3 kg hanging a distance of 150 mm, and then dropped on the surface (SE to predicate).
Dosimetric Properties
Water Equialence Thickness (WET)	5.22mm (from predicate)	41.35mm (Predicate: 5.22mm; Device: 41.35mm; Deemed SE. WET value is compensated for in treatment planning software when considered too high. This implies the increased WET is acceptable due to software compensation.)
Secondary Radiation	Half-life lower than 1 hour; same half-life of 20 minutes as predicate. No long-lived radio-isotopes.	Both proposed and predicate device experience SE values of secondary radiation, half-life lower than 1 hour, same half-life of 20 minutes. No long-lived radio-isotopes are created (SE to predicate).
Spot Size	SE lateral growth in spot size; 1.7-2.2mm both upstream and downstream.	Both devices have SE lateral growth in spot size of a high-energy proton beam as it emerges. Spot sizes are the same 1.7-2.2mm both upstream and downstream (SE to predicate).
WET and Distal Dose Falloff	Perform comparably to predicate when a monoenergetic proton beam is directed into a MLIC.	Both devices perform SE when a monoenergetic proton beam of 228.8 MeV is directed into a MLIC. WET is compensated in treatment planning software (SE to predicate).

Note on "SE" (Substantially Equivalent): The document frequently uses "SE" to indicate that the performance of the proposed device is considered substantially equivalent to the predicate device, even if the numerical values are different (e.g., sag, creep, WET). The justification for "SE" for these differences is provided in the "SE Discussion" column or within the "SE Summary Statement."

Study Information & Acceptance Criteria Details:

The study described is not a clinical effectiveness study, but rather a set of engineering and physical performance tests designed to demonstrate substantial equivalence to a predicate device for regulatory clearance (510(k)). Therefore, many of the typical clinical study parameters (like test sets, ground truth from experts, MRMC, or standalone performance for an AI algorithm) are not applicable here.

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

See the table above. The acceptance criteria for many parameters are implicitly defined by the performance of the predicate device, or by general engineering/safety standards (e.g., IEC60601-1). The document states that the HP PRO Positioning Device is "SE" based on these comparisons and justifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This is not a clinical study involving patient data. The "test set" consists of physical tests and measurements performed on the device itself. The document does not specify a "sample size" in the traditional sense for these engineering tests. Each test (e.g., sag, creep, mechanical strength, dosimetric properties) would have been performed on one or more units of the HP PRO Positioning Device and compared against the predicate's known performance or against established engineering limits.
Data provenance is not explicitly stated in terms of country, but the applicant (Orfit Industries NV) is based in Belgium, implying the tests may have been conducted internally or by a contracted lab. The data is prospective in the sense that these tests were conducted on the new device for the purpose of this submission.

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 this is not a clinical study involving expert interpretation of data or images. The "ground truth" for the physical and dosimetric properties would be established through calibrated measuring equipment and standard testing methodologies.

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

Not applicable. There is no human adjudication process involved in these physical and dosimetric measurements. The evaluation is based on direct comparison to predicate device performance or engineering standards.

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 patient positioning accessory, not an AI-powered diagnostic or treatment planning system that would involve human readers or AI assistance.

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

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

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

The "ground truth" in this context refers to the measured physical properties and dosimetric characteristics of the device, obtained through standardized engineering and radiation physics tests. The predicate device's established performance served as a primary reference for substantial equivalence.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

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

Not applicable.

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