(101 days)
Solo-Sled is a device designed to allow one staff member to be able to position 14 x 17 cassettes behind chest and/or under the back of a patient without causing pain to the patient in lifting or moving them. Solo-Sled will allow positioning of cassettes without requiring two to three staff members to lift the patient once to place the cassette and then the second time to remove the cassette. The device is an accessory to a 14 x 17 radiographic film cassette.
Solo-Sled is a device made from an artifact free (ABS) plastic acrylonitrile butadiene styrene which is injection molded. It has a smooth low resistance outer finish with reinforced edges for extra strength an patient comfort. It has two handles for ease of positioning by staff members. It has dimensions to accommodate a 14 x 17 cassette.
This inquiry is about a medical device accessory, the Solo-Sled Cassette Positioner, and not an AI/ML powered device. As such, concepts like "acceptance criteria," "study," "ground truth," "training set," "multi-reader multi-case (MRMC) study," and "standalone algorithm performance" are not applicable in the context of this 510(k) submission.
The document describes a simple physical device designed to improve the ease of positioning radiographic film cassettes for critically ill patients. The "performance" section focuses on safety and the lack of interference with the radiographic image quality, rather than diagnostic accuracy or algorithmic performance.
Here's why these AI/ML terms don't apply and what the relevant sections of the document describe instead:
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Acceptance Criteria & Reported Device Performance: This would normally refer to metrics like sensitivity, specificity, AUC for an AI model. For the Solo-Sled, the "acceptance criteria" are implied by its intended use and the "performance" section. The device is considered effective if it allows one staff member to position a 14x17 cassette, causes no pain to the patient, does not irritate the skin, is not abrasive, and does not alter radiographic image quality or create distortion. The reported "performance" confirms these points.
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Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all related to the evaluation of a diagnostic or predictive algorithm against a gold standard. The Solo-Sled is a mechanical aid, not a diagnostic tool. Therefore, there are no "test sets," "ground truths," "experts" for diagnostic evaluation, or "algorithms" to be evaluated.
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Type of Ground Truth: For an AI device, this would be pathology, expert consensus, etc. For the Solo-Sled, the "ground truth" is simply the demonstrable physical properties and lack of adverse effects.
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Sample Size for Training Set, How Ground Truth for Training Set Established: These concepts are entirely irrelevant for a non-AI physical accessory.
Instead, the relevant information from the provided document regarding safety and effectiveness is as follows:
Safety and Effectiveness Claims and Supporting Information:
| Acceptance Criteria (Implied) | Reported Device Performance (Supporting Information) |
|---|---|
| 1. Ease of Use (one staff member positioning) | Intended Use Description: "Solo-Sled is a device designed to allow one staff member to be able to position 14 x 17 cassettes behind chest and/or under the back of a patient without causing pain to the patient in lifting or moving them. Solo-Sled will allow positioning of cassettes without requiring two to three staff members..." |
| Substantial Equivalence Comparison: "The Solo-Sled provides a 'sleeve' with round edges and corners... It has low surface resistance which enables a single technologist to simply slide the cassette into position and remove the cassette by sliding Solo-Sled up and out." | |
| 2. Patient Comfort / No irritation / Not abrasive | Performance - Safety and Effectiveness: "The Solo-Sled is made from high impact (ABS) plastic... which poses no health risk either by contact or use with patients. In addition, it does not possess properties that would irritate the skin, nor does it have the potential to be abrasive to the skin during use. A copy of the Material Safety Data Sheet (MSDS) is included for your reference." |
| 3. No alteration of radiographic image quality, distortion, or artifacts | Performance - Safety and Effectiveness: "The Solo-Sled device does not alter the radiographic image quality, create image distortion and is artifact free. The radiographic image quality and technical factors remain the same with and without the use of the Solo-Sled. The physics testing and findings are included for your reference." |
Since this is a non-AI device, the other requested points (sample size for test set/training set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are not applicable and are not mentioned in the provided 510(k) summary. The "study" mentioned for image quality is "physics testing and findings," which would typically involve phantom studies or controlled comparisons, not expert reads or patient outcome data in the same way an AI algorithm is evaluated.
§ 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.