(162 days)
The Mercy babyTAPE device is intended for use by health care professionals to estimate the body weight of infants between the ages of 0 days (birth) and 90 days, using circumferential measurements from specific anatomical landmarks made with the Mercy babyTAPE device for head and chest circumference.
Head: place the Mercy babyTAPE across the frontal bones, slightly above eyebrows and ears, over the occipital prominence, perpendicular to the long axis of the face.
Chest: place the Mercy babyTAPE around the upper torso, passing under the axilla and by the xyphoid process at the level of the nipple. Measure at end-exhalation.
The Mercy babyTAPE device consists of a semi-durable or disposable flexible strip of paper, coated paper, fabric or plastic tape printed on both sides such that one side uses yellow color to indicate its use for the head circumference measurement, while the other side is printed with blue color to indicate its use for the chest circumference measurement. The start end of the device is indicated with color contrasting arrowheads that span the width of the device. Numbered bins are marked on each side proportional to the fractional body weight of newborn and infant patients. The markings correspond to a validated Mercy babyTAPE Method (calculation algorithm) for determining estimated infant body weight.
The Mercy babyTAPE device is intended for health care professionals to estimate the body weight of infants (0-90 days old) using head and chest circumference measurements. The device is a flexible strip of tape with numbered bins, printed on both sides (yellow for head, blue for chest), and the measurements are used with a validated algorithm to estimate weight.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation between actual weight and predicted weight | Regression slope of 0.96 (95% CI 0.94, 0.98), intercept of 0.08 (95% CI 0.03, 0.12) |
| Mean error | -69 ± 257 grams |
| Mean percentage error | -1.3 ± 6.9% |
| Percentage of infants predicted within 10% of actual weight | 0.86 (86%) |
| Percentage of infants predicted within 15% of actual weight | 0.99 (99%) |
| Concordance Correlation Coefficient (CCC) | 0.98 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions a "predictive performance study" that evaluated the babyTAPE device's predicted weights against measured weights. It also refers to "Study TAP02" which was used to derive the algorithm. The validation data subset from Study TAP02 appears to be the most relevant "test set" for the final performance evaluation.
- Test Set Sample Size: 416 infants (listed as the validation group in TAP02).
- Data Provenance: The algorithm was developed using data from "2097 US infants at 8 sites" (Study NICHD-2014-TAP02). The predictive performance study described seems to be a validation of this algorithm. The study was likely prospective as it involved obtaining anthropometric data for the purpose of algorithm development and validation. The country of origin is the USA.
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)
The ground truth for the test set was established using "weight measured on a calibrated scale." This implies direct measurement rather than expert interpretation. Therefore, experts were not involved in establishing the ground truth measurements themselves, but rather in conducting these measurements accurately. The document does not specify the qualifications of the individuals performing the weight measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The ground truth was direct weight measurement on a calibrated scale, which typically does not involve adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This device is a manual measurement tool with an integrated algorithm, not an AI system designed to assist human readers in image interpretation or diagnosis. The study focused on the accuracy of the device's predicted weight compared to actual weight.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance study evaluated the "baby TAPE device predicted weights with weight measured on a calibrated scale." The device itself incorporates the measurement (human-in-the-loop for taking circumference measurements) and then uses the algorithm to provide the predicted weight. Therefore, it's not purely "algorithm-only" in the sense of a fully automated system without any human interaction. However, the reported performance metrics (regression slope, mean error, percentage accuracy) directly assess the output of the device's algorithm given the anthropometric inputs. The comparison to the "reference measuring tape estimated weight" suggests a direct comparison of the Mercy babyTAPE algorithm's performance against another established method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was actual measured body weights obtained using a calibrated scale.
8. The sample size for the training set
The algorithm was developed using demographic and anthropometric data from Study TAP02.
- Training Set Sample Size: 1681 infants (for model development).
9. How the ground truth for the training set was established
For the training set (Study NICHD-2014-TAP02), the ground truth for weight was established via direct measurement of infant weight and various circumferential and segmental anthropometric measures. These measurements were used to derive the algorithm. This would involve using calibrated measuring tools by trained personnel. The study explicitly states, "Data [was] derived from 2097 US infants (n = 1681 for model development, n = 416 for validation)." It further details the types of measurements taken.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.