(99 days)
The Portable Supine Patient Support and Cassette Holder is a supine support device intended to lay flat on a flat surface to hold and position a radiographis cassette, also to hold and position a patient for radiographic x-ray exposure. I intended for medical use.
Indications for Usessupine support intended to lay flat on a surface to i hold and position radiographic cassette, also to hold and position patient for radiographic exposure for medical use.
The Portable Supine Patient Support and Cassette Holder is a portable, nonionizing radiation device used for scoliosis radiography of the spine. The device consists of a head support, a rectangular cassette holder (94cm×40.5cm), which will hold the cassette, a foot support, and a removable cover top on top of the cassette holder.
The provided text describes a 510(k) premarket notification for a medical device, the "Portable Supine Patient Support and Cassette Holder." The acceptance criteria and the study to prove the device meets these criteria are mainly focused on the radiotranslucency of the carbon fiber material used in the device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 21 CFR Ch. 1, J, 1020.30(n) Table 2 (2008) / 2006) | Stated Requirement (mm Al equivalent) | Reported Device Performance (mm Al equivalent of carbon fiber sample) | Conclusion |
|---|---|---|---|
| "Tabletop, movable, 'without articulated joints'" | Not greater than 1.7 mm Al equivalent | Sample 1 (Vanguard): 0.39 mm Al eq. | Meets |
| "Tabletop, with radiolucent panel having one articulated joint" | Not greater than 1.7 mm Al equivalent | Sample 2 (JPI): 0.30 mm Al eq. | Meets |
| "Tabletop, stationary, 'without articulated joints'" | Not greater than 1.2 mm Al equivalent | Sample 1 (Vanguard): 0.39 mm Al eq. | Meets |
| Sample 2 (JPI): 0.30 mm Al eq. | Meets |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Two samples of carbon fiber material were tested: "Vanguard 4"X4"" and "JPI 6"X6"". The thickness for Vanguard was 2.76mm and for JPI was 2.63mm.
- Data Provenance: The tests were conducted by K & S Associates, Inc. (Nashville, Tennessee) on March 7, 2008. The data is retrospective relative to the submission date of September 2, 2008. The country of origin is not explicitly stated for the data generation, but the testing company is US-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for this compliance study is based on a regulatory standard (21 CFR Ch. 1, J, 1020.30(n) Table 2), not expert consensus on medical images. Therefore, the concept of "experts establishing ground truth" as it would apply to diagnostic imaging accuracy studies is not directly applicable here.
The tests were measured by Brad Horn (Calibration Tech) and reviewed by Larry G. Bryson, MS-CHS / MS, CHP (Associate Director). These individuals are qualified in relevant instrumentation and radiological health, ensuring the measurements are performed correctly against the regulatory standard.
4. Adjudication method for the test set
Not applicable. This was a direct measurement against a published regulatory standard, not a subjective assessment requiring adjudication. The measurements were taken and reviewed by an independent lab.
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 passive patient support and cassette holder. It does not involve AI, human readers, or diagnostic image interpretation. The study is about the physical properties of the material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used
The ground truth used is a regulatory standard for radiotranslucency, specifically 21 CFR Ch. 1, J, 1020.30(n) Table 2 (2008 / 2006) criteria. The device performs measurements to demonstrate compliance with these objective criteria.
8. The sample size for the training set
Not applicable. This study does not involve machine learning or data-driven model training. It is a physical property test of material samples.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, no ground truth needed to be established for it.
§ 892.1850 Radiographic film cassette.
(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.