(254 days)
The ZEUS 9.9 and VENUS 5,5 body composition analyzers 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 only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen
Model ZEUS 9.9/VENUS 5.5 of Jawon Medical is compact, automatic General: Impedance plethysmographer intended for estimating of body composition of user such as PBF(Percentage of Body Fat), MBF(Mass of Sody 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/Bioelectrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hin Ratio) of the user. These devices are intended for use only in healthy subjects between age of 7-89. The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen.
Operation: The subject device employs a measurement algorithms which is called BIA method, to measure user's body composition.
ZEUS 9.9/VENUS 5.5 device's tetra-polar type electrode connect to human body and then send an minute electric current like 360 A human body and then ZEUS 9.9/VENUS 5.5 device can measure impedance of the human body.
ZEUS 9.9/VENUS 5.5 can measure body composition of user with personal data which already saved height, weight, gender, ages and new calculated body impedance.
Power: Model ZEUS 9.9/VENUS 5.5 is AC line powered(AC 110~120V, 50/60Hz)
The provided text is a 510(k) summary for the JAWON MEDICAL BODY COMPOSITION ANALYZER Models VENUS 9.9 and ZEUS 5.5. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and explicitly defining a study to meet those criteria.
Therefore, the document does not provide explicit acceptance criteria with numerical targets. Instead, it states that the device is "equivalent in performance" and shows "no significant difference" to the predicate devices.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit numerical acceptance criteria are not provided. The performance is assessed against predicate devices.
| Performance Metric (Implied) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Equivalent to Predicate Devices (BODYSTAT Quad Scan 4000, TANITA BC-418) | "Results of the testing showed that the ZEUS 9.9 body composition analyzer is equivalent in performance to the predicate devices." |
| Statistical Difference | No significant difference from Predicate Devices | "There is no significant difference between the ZEUS 9.9 body composition analyzer and predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "healthy subjects."
- Data Provenance: The study was likely conducted in Korea, given the company's address. The document does not explicitly state if it was retrospective or prospective, but clinical testing typically implies prospective data collection for performance comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a ground truth for the test set. The study compares the device's measurements directly to those of established predicate devices.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as a truth standard itself for the test set, as the comparison is against predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This device is a standalone analyzer, and the study compares its output directly with other devices. It does not involve human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, this was a standalone performance study. The device, which uses a BIA algorithm, was compared directly against other BIA devices.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate devices (BODYSTAT Quad Scan 4000 and TANITA BC-418). The study aims to demonstrate that the Jawon device's measurements align with these established devices.
8. The Sample Size for the Training Set
The document does not provide information about a training set since it focuses on a comparison study for regulatory submission rather than algorithm development details. The BIA method is a well-established technique used by the device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no information on a training set is provided.
§ 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.