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510(k) Data Aggregation
(91 days)
KADA RESEARCH, INC.
Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
To measure grip or pinch strength in an injured and uninjured hand.
To conduct pre-employment screening for physically demanding job activities.
To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.
The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. The applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits simultaneously. The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.
Here's an analysis of the provided 510(k) submission for the KaDance 2000 Hand Sensor System, focusing on acceptance criteria and study details:
The provided document (K012492 for the KaDance 2000 Hand Sensor System) is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study acceptance criteria and results in the same way a PMA or a more extensive clinical study report would.
Key takeaway: This 510(k) submission does not contain specific acceptance criteria, detailed study designs, or performance metrics for a clinical study proving the device meets those criteria. It relies heavily on a claim of "extensive safety, performance, and validations" and "equivalence in safety and efficacy to its predicated devices."
Therefore, many of the requested elements cannot be extracted directly from this document. I will provide what is available and note when information is missing.
Acceptance Criteria and Device Performance Study Analysis
Based on the provided K012492 510(k) submission for the KaDance 2000 Hand Sensor System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Target Performance) | Reported Device Performance |
|---|---|
| Not specified in the 510(k) summary. | The 510(k) states: "The KaDance device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." |
| Functional requirements (e.g., accuracy, precision of force measurement, temporal resolution) | Not explicitly quantified or detailed. The device measures forces exerted by digits as a function of time, as rapidly as once every 2 ms for all three digits simultaneously. The submission implies these functional requirements were met. |
| Safety standards compliance | "Safety tests have further been performed to ensure the device complicable industry and safety standards." |
| Equivalence to predicate devices (Digit-grip with LCD K981730) | The submission concludes: "The KaDance device is equivalent in safety and efficacy to its predicated devices." However, no specific comparative data or metrics are provided. |
Missing Information: The document does not specify quantitative acceptance criteria or detailed, quantifiable performance metrics for the KaDance 2000 system. The "performance specifications" are mentioned but not detailed.
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified.
- Data provenance: Not specified. The submission mentions "extensive safety, performance, and validations" and "final testing for the systems," implying internal testing rather than a large-scale clinical study with external data. There is no mention of country of origin or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable/not specified.
- Qualifications of experts: Not applicable/not specified.
Missing Information: The nature of the testing described (functional and performance tests) does not involve expert ground truth establishment in the traditional sense of diagnostic accuracy studies.
4. Adjudication method for the test set
- Adjudication method: Not applicable/not specified.
Missing Information: Adjudication is typically relevant for studies involving subjective interpretation (e.g., medical image reading), which is not the primary focus of the described "performance tests" for a force measurement device.
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
- MRMC study: No, an MRMC study was not done, nor would it be relevant for this type of device.
- Effect size: Not applicable.
Missing Information: The KaDance 2000 Hand Sensor System is a force measurement device, not an AI-assisted diagnostic tool involving "human readers" or "AI assistance" in the way MRMC studies typically assess.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is less relevant for a dynamometer device. The device itself is the "algorithm" or measurement tool. Its "standalone performance" is implicitly what the "functional requirements and performance specifications" tests were designed to ensure. However, the document does not detail how this standalone performance was assessed or quantified.
Missing Information: Specific details on the methodology and results of any standalone performance assessment are not provided beyond a general statement of "testing."
7. The type of ground truth used
- Ground truth: For a force measurement device, the "ground truth" would typically involve calibrated force standards or reference measurements. The submission mentions "performance tests" but does not specify the ground truth methodology or reference standards used.
8. The sample size for the training set
- Training set sample size: Not applicable/not specified.
Missing Information: This device is a measurement tool, not an AI/ML model that would require a "training set" in the conventional sense. The "training set" concept is not relevant to the described device development and testing.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/not specified.
Missing Information: As the concept of a "training set" does not apply to this device, neither does the establishment of its ground truth.
In summary, the K012492 510(k) submission for the KaDance 2000 Hand Sensor System focuses on demonstrating substantial equivalence to a predicate device (Digit-grip with LCD K981730) and claims general "extensive safety, performance, and validations." It explicitly states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, it does not provide the specific acceptance criteria, detailed study designs, or quantified results of these tests in this public summary. Many of the questions above are designed for AI/ML-driven diagnostic devices, which this dynamometer is not.
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