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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

510(k) Submission, New, KaDance 2000

KaDa Research, Inc., Stafford, Texas 77477

NOV 02 2001

K012492
10F3

Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.

1. Company making the submission:

	Company	Correspondent (contract):
Name:Address:	KaDa Research, Inc.10701 Corporate DriveSte. 100Stafford, Texas 77477	Delphi Consulting Group11874 South Evelyn CircleHouston, Texas 77071-3404
Telephone:	281-437-9119 voice281-240-7122 fax	713-723-4080 voice208-694-6953 fax
Contact:	William C. Paske, Ph.D.President & CEO	J. Harvey KnaussConsultant

2. Device:

Proprietary Name:	KaDance Hand Sensor System
Common Name:	Force measurement device
Classification Name:	AC-powered dynamometer

3. Predicate Devices;

Digit-grip with LCD K981730

4. Classifications Names & Citations:

21 CFR 888.1240 AC-powered dynamometer, Class II, LLB, 87 Orthopedics.

5. Description:

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. inger (againe) and intil migor (aally 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.

{1}------------------------------------------------

510(k) Submission, New, KaDance 2000

KaDa Research, Inc., Stafford, Texas 77477

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.

Operation of the system is menu driven from the laptop computer. When a subject test without errors has been completed, the data is transmitted to a central location via modem or other hispeed data transmission means and hard copies are produced. Data is returned to test director by whatever means as directed. Interpretation of data and any diagnosis resides with the test director or other medical practitioner.

Indications for use:

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.

7. Contra-indications:

Should not be use on a subject with burns, open wound, rash or fracture. Use with caution when subject hands are sensitive to pain. Do not counter accepted clinical practice or institution guidelines.

Comparison:

The KaDance™ device has the same device characteristics as the predicate devices, except the predicate devices do not have the capability to transmit data to a distance location.

Test Data:

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. Safety tests have further been performed to ensure the device complicable industry and safety standards.

Literature Review:

A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safequards have been incorporated in the design of the KaDance™ device.

Section 5 Page 3 510(k) Submission Page #

{2}------------------------------------------------

510(k) Submission, New, KaDance 2000

KaDa Research, Inc., Stafford, Texas 77477

1012492
3 OF 3

11. Conclusions:

The conclusion drawn from these tests is that the KaDance device is equivalent in safety and efficacy to its predicated devices.

Section 5 Page 4

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NOV 02 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KaDa Research, Inc. c/o Mr. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071

Re: K012492

Trade/Device Name: KaDance 2000 Hand Sensor System Regulation Number: 21 CFR 888.1240 Regulation Name: AC-powered dynamometer Regulatory Class: Class II Product Code: LBB Dated: July 31, 2001 Received: August 3, 2001

Dear Mr. Paske:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Mr. Harvey Knauss

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark N. Millikan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number K_ 012 492

Device Name: KaDance 2000 Hand Sensor System

Indications for use:

Any situation where the hand grip or pinch strength would be a valuable I 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. 트
To conduct pre-employment screening for physically demanding job 트 activities.
To establish an industrial strength testing program in general, and to 회 match the strength of workers to the strength demands of specific job duties in the workplace.

Prescription Device: NO

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use $\checkmark$

(Per 21 CFR 801.109)

510(k) Number

O. Mark N. Mullersen

storative

K012492

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.