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K Number
K981730
Device Name
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
Manufacturer
NK BIOTECHNICAL CORP.
Date Cleared
1998-07-17

(63 days)

Product Code
LBB
Regulation Number
888.1240
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ULTIMATE System is indicated for use as follows:

  1. to measure grip or pinch strength in an injured and uninjured hand.
  2. to follow an injury through the rehabilitation process and measure progress or lack of progress, in terms of grip or pinch strength, of the therapy regimen or medical treatment.
  3. to document baseline grip or pinch strength of the hands and lifting, pulling and pushing strength capabilities of employees and to monitor the strength of employees in the workplace over time.
  4. generally, in 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 to his/her hand(s).
  5. 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 (lifting, pulling and pushing protocols) in a simulated test.
  6. to conduct pre-employment screening for physically demanding job activities.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to NK Biotechnical Corporation for their device, the Digit-Grip with LCD, Model DGR 002. It declares substantial equivalence to a predicate device and outlines the indications for use.

Crucially, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The letter primarily focuses on regulatory approval based on substantial equivalence, not on specific performance data.

§ 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.