(126 days)
For Measurement in healthy subjects of: Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass; Actual: Weight, BMI, Impedance Values
SLIMMANAGER is a body composition analyzer and uses Bioelectrical Impedance Analysis technology to determine body composition parameters. Using a principle that an electric current has a low impedance when it flows in muscle or cellular fluids containing lots of water while it has a high impedance such as in fat and bone tissues slowing and stopping an applied current, BIA sends an extremely weak electric current through the body and detects the relative response after it flows our body's various substances, and then it can determines lean tissue, fat, water mass. All measurements made by SLIMMANAGER can be recorded & saved in the website real-time by the Internet transmission as well in the device, and in his own page people could check their changing progress even a minute change without an expert's advice at anywhere, at anytime. N-40 is designed by Linux system with touch monitor, while SM-300 should be interfaced with customer's PC.
The provided text is a 510(k) Summary for a medical device called "SLIMMANAGER, Body composition analyzer (Models: N40, SM-300)". It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance data in a format typically found in clinical trials.
Therefore, the requested information elements related to specific acceptance criteria, test set details (sample size, data provenance, expert involvement, adjudication), multi-reader multi-case studies, standalone performance, and training set details are not explicitly available within the provided text.
The document states that "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices." and later, "After analyzing both bench and clinical testing data, it is the conclusion of AIIA Communication Inc. that the SLIMMANAGER, Body composition analyzer (Models: N40, SM-300). as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."
This indicates that a study was conducted, and its results led to the conclusion of substantial equivalence. However, the specific acceptance criteria, method, and results of that study are not detailed in this summary.
Here's a breakdown of what can be inferred or is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided. The document states that "bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," implying an comparison was made, but the specific metrics, thresholds, or performance values are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly provided. The document mentions "clinical testing data" but does not specify the sample size, data provenance, or whether it was retrospective or prospective.
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)
- Not applicable/Not explicitly provided. For a body composition analyzer using Bioelectrical Impedance Analysis (BIA), ground truth would typically be established against a gold standard method (e.g., DEXA or underwater weighing), not by expert consensus interpreting images. The document does not describe how ground truth was established, nor does it mention any expert involvement for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not explicitly provided. As expert consensus is not the stated method for ground truth, an adjudication method isn't relevant in the typical sense.
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
- Not applicable. This device is a standalone body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is what is being evaluated for its "safe and effective" performance in comparison to predicate devices, indicating a standalone evaluation of its measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but implied to be a comparison to predicate devices. The document states "as safe and effective as the predicate devices." In BIA studies, "ground truth" for body composition parameters is typically established using established gold-standard methods (e.g., DEXA, underwater weighing, or multi-compartment models). The 510(k) summary doesn't specify which "ground truth" was used in their clinical testing. It primarily focuses on equivalence to other BIA devices.
8. The sample size for the training set
- Not applicable/Not explicitly provided. While the device uses Bioelectrical Impedance Analysis (BIA), which can involve algorithms, the summary doesn't describe a machine-learning-based "training set" in the context of AI. BIA devices typically use established physiological models and equations.
9. How the ground truth for the training set was established
- Not applicable/Not explicitly provided. See point 8.
Summary of available information regarding the study:
- Device: SLIMMANAGER, Body composition analyzer (Models N40, SM-300)
- Purpose of Study (as described): To demonstrate that the new device is as safe and effective as the predicate devices (Biospace InBody 230 K062603; AIIA communication Inc. SLIMMANAGER (SM-X, SM-E) K051589).
- Methodology: Bench and clinical testing was performed.
- Conclusion: The device is substantially equivalent to the predicate devices.
- Measured Parameters (Indications for Use): Estimated: ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass. Actual: Weight, BMI, Impedance Values.
To fully answer your questions, one would need to refer to the detailed clinical study report that was submitted as part of the 510(k) application, which is not included in this 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.