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K Number
K980470
Device Name
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
Manufacturer
AMERICAN INSTITUTE OF KORYO HAND THERAPY
Date Cleared
1998-04-06

(59 days)

Product Code
MQX
Regulation Number
880.5580
Type
Traditional
Panel
HO
Reference & Predicate Devices
K962419
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Description

The subject of this 510(k) application - the KHT Soft Sooji Needle - is a sterilized, silicon coated, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.

AI/ML Overview

The provided text from K980470 is a 510(k) summary and FDA clearance letter for the KHT Soft Sooji Needle, which is a hand acupuncture needle. This document does not describe a study involving performance metrics, acceptance criteria, or ground truth as would be associated with a device using AI or advanced diagnostic capabilities.

The clearance is based on substantial equivalence to previously marketed devices, not on a performance study against specific acceptance criteria. The criteria for acceptance in this context refer to meeting the requirements for 510(k) clearance, primarily by demonstrating equivalence to a predicate device.

Therefore, I cannot populate the requested table and answer the specific questions about device performance studies. The provided text does not contain that information.

Explanation based on the provided document:

This 510(k) notification is for a Class II medical device, a KHT Soft Sooji Needle (Hand Acupuncture Needles). The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, both those marketed prior to May 28, 1976, and other currently marketed single-use acupuncture needles (specifically referencing CW-Disposable Acupuncture Needle, K962419).

The document states: "The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture." This indicates that the device meets general standards for its type, rather than specific performance metrics from a controlled study comparing its output to a defined ground truth.

Therefore, the following information is not present in the provided text:

  1. A table of acceptance criteria and the reported device performance: Not applicable, as no performance study with specific metrics is described for the KHT Soft Sooji Needle against an "acceptance criteria" for diagnostic accuracy or similar.
  2. Sample size used for the test set and the data provenance: Not applicable.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  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 is not an AI-enabled device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 880.5580 Acupuncture needle.

(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.