(31 days)
These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.
These devices are intended for use only in healthy subjects between the age of 7-89.
The X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are body composition analyzers intended for use only in healthy subjects between the age of 7-89. The devices employ BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet (or ankles), and then measure body composition using an experimentally derived algorithm. For only XBIA 500, optional ankle electrode is not supplied. The devices are powered by AC100~230V 50/60Hz.
The provided document is a 510(k) summary for Jawon Medical Co., Ltd.'s Body Composition Analyzers. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the current device meets specific acceptance criteria through a novel study. As such, the document does not contain the detailed information typically found in a clinical study report that directly addresses acceptance criteria and device performance in the way requested.
Here's a breakdown of the information that can be extracted or inferred, and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as a set of acceptance criteria for the new devices (X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, and XBIA 900).
Instead, the document states:
- "The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the modified devise and the predicate device."
- "Conclusion: II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are as safe, as effective, and perform as well as the predicate devices VENUS 5.5 and ZEUS 9.9."
This implies that the acceptance criterion was "no significant difference" in performance compared to the predicate devices (VENUS 5.5 and ZEUS 9.9). The reported device performance is that this criterion was met. However, specific metrics (e.g., accuracy for PBF, LBM etc., and the numerical performance values) for either the new or predicate devices are not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "clinical comparison tests" but does not give the number of subjects or measurements.
- Data Provenance: The study was a "clinical comparison test" conducted in South Korea by Jawon Medical Co., Ltd. The document does not specify if it was retrospective or prospective, but clinical comparison tests are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable/Not specified. The document describes a "clinical comparison test" against a predicate device, not a study where experts establish ground truth for a diagnostic finding. The ground truth for body composition analyzer performance is typically established by comparing against a reference method (e.g., DEXA, hydrostatic weighing) or by demonstrating equivalence to an already validated device, rather than expert consensus on images.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. Similar to the previous point, an adjudication method is not relevant for this type of equivalence testing where the primary goal is comparison to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This document describes a "clinical comparison test" of a body composition analyzer, which is a device that provides quantitative measurements, not a device used for visual interpretation by multiple readers like an imaging device. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. Body composition analyzers are standalone devices that provide measurements directly. The comparison test likely evaluated the device's measurements directly against the predicate device's measurements. There is no "human-in-the-loop" component in the operation of the algorithm itself for these devices.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the new device's performance was its equivalence to the predicate device (ZEUS 9.9). The predicate device itself would have been validated against a more direct "ground truth" (e.g., DEXA, hydrostatic weighing, or other accepted reference methods) in its own regulatory submission, but this document does not detail that.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. Body composition analyzers (especially BIA-based ones) use experimentally derived algorithms. While these algorithms are "trained" or developed using data, the document does not specify the sample size used for developing the underlying algorithm for the new devices or the predicate devices.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not specified. The document states the devices "measure body composition using an experimentally derived algorithm." This implies that the algorithm was developed using a dataset where actual body composition (likely measured by gold-standard methods like DEXA or hydrostatic weighing) was known. However, the details of this process, including the specific ground truth methods or how they were established, are not provided in this 510(k) summary.
§ 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.