(626 days)
The SEM Scanner (Model 200) is intended to be used by healthcare professionals as an adjunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
The SEM Scanner (Model 200) is a hand-held, portable device that consists of a single electrode sensor, an integrated pressure sensor, and hardware and software to run a user interface device screen that displays the device status, battery status, SEM Value, and SEM Delta ("SEM Δ"). The SEM Scanner (Model 200) is pre-calibrated. The SEM Scanner (Model 200) is provided with an inductive charging mat and power supply for recharging the device unit.
The SEM Scanner (Model 200) assesses changes in electrical capacitance of tissue and expresses the result in a SEM Value of 0.3 to 3.9. SEM is a unitless number (not an International System of Unit). The SEM Scanner (Model 200) displays a △ (delta) value after taking a minimum of three (3) SEM Values readings. A minimum of four readings were taken to obtain a result during the supporting clinical studies. The reported SEM A is used as an adjunct to the standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
Here's a breakdown of the acceptance criteria and study details for the SEM Scanner (Model 200), based on the provided text:
Description of Acceptance Criteria and Proving Study
The SEM Scanner (Model 200) is intended to be used by healthcare professionals as an adjunct to standard of care for identifying patients at increased risk for pressure ulcers at the heels or sacrum. The primary effectiveness was evaluated based on the device's ability to detect positive and negative instances related to pressure ulcer development.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Criteria Description | Acceptance Value | Reported Device Performance and Confidence Interval | Met? |
|---|---|---|---|---|
| Effectiveness | Positive Detection (Sensitivity): Observation of two or more SEM Δ >0.5 from three consecutive series of SEM Scanner readings prior to pressure ulcer diagnosis by clinical judgment of the Specialist. A sensitivity of at least 0.70 (70%) is defined for positive detection success. | ≥ 0.70 (70%) | 87.4% (95% CI: 77.8%, 96.7%) | Yes |
| Negative Detection (Specificity): Observation of two or more SEM Δ 0.5) were likely established through earlier engineering or pre-clinical work, but a formal clinical training set is not mentioned. |
9. How the Ground Truth for the Training Set Was Established
As a separate "training set" is not explicitly mentioned for an AI/algorithm in the provided text, the method for establishing ground truth for such a set is also not described. The clinical study described served as the validation for the device's performance based on its inherent mechanism and pre-established thresholds.
§ 876.2100 Pressure ulcer management tool.
(a)
Identification. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user's decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.