(289 days)
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
This document is a 510(k) premarket notification approval letter for the Oregon Scientific High Precision Body Weight Monitor with Body Fat Index, Model GA101, and an "Indications for Use" statement.
The provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. This is a regulatory approval document and not a scientific study report.
Specifically, the document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- The "Indications for Use" are: "The device measures body weight, and impedance using Bioelectrical Impedance Technology (BIA) and calculates body fat percentage, BMI, with results displayed in LCD panel. The intended use of this device is for 7 to 99 years old normal subjects and not for recommended personal with implanted internal device like pacemaker or pregnant women to use this device."
To answer the detailed questions about acceptance criteria and study design, a different kind of document (e.g., a clinical study report, a validation report submitted as part of the 510(k) application, or the 510(k) summary itself)containing performance data would be needed.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's how to address the request based on the lack of specific information in the provided document:
Acceptance Criteria and Device Performance Study (Not Available in Provided Text)
The provided document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device, rather than providing detailed performance data or acceptance criteria from a specific study. Therefore, most of the requested information cannot be extracted directly from this document.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. Performance criteria would typically be defined for accuracy of body weight, impedance, body fat percentage, and BMI calculations. | Not specified in this document. The document states the device "measures body weight, and impedance... and calculates body fat percentage, BMI." However, specific numerical performance results (e.g., accuracy, precision) relative to any acceptance criteria are not provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Often, data for 510(k) clearance might come from internal company testing, or if clinical data was used, its origin (e.g., country) would be in a study report. The document itself is from the USA FDA.
- Retrospective or Prospective: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not specified in this document. Ground truth for body composition measurements would typically be established using reference methods (e.g., DEXA for body fat), not expert consensus in this context.
4. Adjudication method for the test set:
- Not applicable/Not specified in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not specified in this document. This device is a standalone body weight and body fat monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "Indications for Use" describes the device's function: "The device measures body weight, and impedance using Bioelectrical Impedance Technology (BIA) and calculates body fat percentage, BMI, with results displayed in LCD panel." This implies standalone algorithmic performance for calculating body fat and BMI from impedance measurements. However, no specific performance metrics like accuracy or precision are provided in this document.
7. The type of ground truth used:
- Not specified in this document. For body composition devices, ground truth for body fat percentage would typically be established using a gold standard method such as Dual-energy X-ray Absorptiometry (DEXA), underwater weighing, or MRI.
8. The sample size for the training set:
- Not specified in this document. (If algorithms are involved, training sets would be used, but this document does not contain details about model development).
9. How the ground truth for the training set was established:
- Not specified in this document.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.