(57 days)
The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and freatments that use digital palpation.
The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).
The Palpometer is a device designed to quantify fingertip pressure during digital palpation to assess patient sensitivity to tactile stimuli. The provided documentation (K060125) describes the device and references several studies to demonstrate its equivalence and performance relative to conventional pain measurement methods.
Here's an analysis of the acceptance criteria and the studies mentioned:
1. Table of Acceptance Criteria and the Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" with specific quantitative thresholds that the device must meet for approval. Instead, it presents a summary of "Substantial Equivalence Data" by comparing the Palpometer's performance with established methods of pain measurement found in published literature. The reported performance focuses on correlations, reliability, and differences in statistical significance.
| Acceptance Criteria (Inferred from study outcomes and comparisons) | Reported Device Performance (as described in the studies cited) |
|---|---|
| Intraobserver reliability (compared to conventional methods) | Atkins et al. (1992): Intraobserver error of 0.12 for Palpometer vs. 0.2 for conventional method (in rheumatoid arthritis tender joint scores), indicating superior reliability. |
| Construct Validity / Correlation with conventional measurements (indicating agreement or ability to measure the same underlying construct) | Atkins et al. (1992): Correlation coefficient between Palpometer and conventional measurements increased from 0.62 to 0.78 (excluding less sensitive instruments), indicating a high level of construct validity. |
| Interobserver agreement/reliability (demonstrating consistency across different observers) | Bendtsen et al. (1995): Sum of tenderness scores by two observers using conventional palpation differed significantly (P=0.0003), while results did not differ using pressure-controlled palpation (P=0.89), demonstrating improved interobserver reliability with the Palpometer. |
| Correlation with pain intensity (demonstrating the device's ability to measure pain) | Bendtsen et al. (1995): Positive linear correlation between pressure and pain intensity (P=0.00006) in headache tender point scores. |
| Correlation with conventional scores / Test-retest reliability (in specific conditions like fibromyalgia) | Bennet et al. (1996): Good correlation (point estimates >0.7) between Palpometer and conventional scores in fibromyalgia. Test-retest measurements showed similar correlation (>0.7), indicating good reliability. |
| Ability to show a linear relationship between pressure and pain (as expected in controls) | Bendsten et al. (1997): In controls, a linear relationship between pressure and pain was found in a double logarithmic plot (slope (ß) was 3.5 ± 0.66 log mm/log Uj P |
§ 890.1615 Miniature pressure transducer.
(a)
Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.(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 § 890.9.