ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.

AI/ML Overview

The provided text is a 510(k) premarket notification for the SEDATELEC ASP Acupuncture Needles. It does not describe an acceptance criteria study or report device performance against specific criteria in the way typically expected for an AI/CADe device. Instead, it demonstrates substantial equivalence to a predicate device, which is a common regulatory pathway for medical devices.

Therefore, many of your requested points are not directly applicable or cannot be extracted from this document, as the focus is on demonstrating similarity to an already approved device rather than proving novel performance against predefined criteria through a clinical study.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

This document does not present acceptance criteria or reported device performance for the ASP Acupuncture Needles in terms of specific metrics like sensitivity, specificity, or accuracy. The demonstration of safety and effectiveness relies on substantial equivalence to a legally marketed predicate device (Seirin - S & Seirin - Pionex acupuncture needles).

Substantial Equivalence Comparison (Excerpted from the document):

Equivalency Comparison Feature	SEDATELEC ASP & ASP Gold acupuncture needles	SEIRIN - S SEIRIN - PIONEX acupuncture needles
Device Type:	Tack	Tack
Intended use:	Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states	Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
Invasive Length (mm)	2.1mm	From 15 to 50mm From 1.5 to 1.8 mm
Gauge (diameter in mm)	0 to 0.7 mm	From 0.22 to 0.26mm From 0.20 to 0.35mm
Needle Tip Shape	Taper	Taper
Needle shape	Harpoon shape	Stylet Thumbtack shape
Biocompatibility	ASTM 430F surgical stainless steel (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84)	Same
Materials	needle: surgical stainless steel (+ a copper layer and a gold layer for ASP Gold)	needle : surgical stainless steel handle : plastic
Sterilization Method	Gamma radiation at a validated dose level of 25kGv	Sterilized with Ethylene oxide gas (for predicate - note this is a difference but still accepted for substantial equivalence)

The core "acceptance criteria" here is that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to a 510(k) submission based on substantial equivalence for a physical device like an acupuncture needle. There isn't a "test set" of data in the context of an AI/CADe algorithm. The evaluation is based on manufacturing processes, materials, intended use, and general device characteristics compared to a known safe and effective predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of expert review for ground truth is associated with AI/CADe performance studies.

4. Adjudication method (e.g. 2+1, 3+1, none) 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/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/CADe device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of 510(k) submission, the "ground truth" for safety and effectiveness is established by the legally marketed predicate device. The fundamental premise is that if the new device is sufficiently similar in design, materials, and intended use to an existing device, it can be presumed to be equally safe and effective without requiring a full de novo approval process.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/CADe device.

Summary based on the document:

The SEDATELEC ASP Acupuncture Needles were approved based on substantial equivalence to existing legally marketed acupuncture needles (Seirin - S & Seirin - Pionex). The FDA determined that the device is as safe and effective as the predicate device because it shares similar technological characteristics (materials, intended use, sterilization method (though different, it is validated), and basic design). There was no need for a clinical "acceptance criteria" study in the context of AI/CADe performance, as the device is a simple, physical medical instrument.

Summary

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K983798

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1.	Device Name(s):	ASP - Acupuncture Needles
	Common Name:	Acupuncture Needles
	Classification Name:	Needle, Acupuncture

1. Establishment Name & Registration Number: SEDATELEC Name: Number: 8020802
1. Classification: 21 CFR, § 880.5580 Device Class: Class II Classification Panel: General Hospital Product Code: MQX

Company Contact: 4.

Miss Tonia Courant SEDATELEC Tel : (+33) 4 72 66 33 22 Fax : (+33) 4 78 50 89 03

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

5. Special Controls:

Special controls for this device type do not exist.

8. Substantially Equivalent Device(s):

Seirin - S & Seirin - Pionex acupuncture needles.

7. Device Description:

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

Manufacturing Facility: ASP acupuncture needles are manufactured by SEDATELEC a registered, ISO compliant medical device manufacturing facility located in France.

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Sterllization/Re-sterilization: 8.

The ASP needle are cleaned/disinfected and manufactured in a clean room meeting FED STD 209 E requirements) in accordance with the US GMP requirements (QSR). The devices are supplied sterile and are single use only. No attempt should be made to resterilize the product.

Sterilization method: ASP needles are sterilized by Gamma radiation at a validated dose level of 25kGv (kiloGray). The sterilization process is applied on finished devices following final packaging. The sterilization process is applied in accordance with EN552 and ISO 11137 standards by a qualified sterilizers are registered by the FDA with a Drug Master File type I. Visual indicators and dosimeters are used to verify product sterility. The radiation dose has been validated to get the sterility assurance level of 10° in accordance with the ISO 11737-1 standard.

EquivalencyComparisonFeature	SEDATELECASP & ASP Gold acupunctureneedles	SEIRIN - SSEIRIN - PIONEX acupuncture needles
Device Type:	Tack	Tack
510(k) number		K970254
Intended use:	Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states	Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
Invasive Length (mm)	2.1mm	From 15 to 50mmFrom 1.5 to 1.8 mm
Gauge (diameter in mm)	0 to 0.7 mm	From 0.22 to 0.26mmFrom 0.20 to 0.35mm
Needle Tip Shape	Taper	Taper
Needle shape	Harpoon shape	StyletThumbtack shape
Biocompatibility	ASTM 430F surgical stainless steel (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84)	Same
Materials	needle: surgicalstainless steel (+ a copper layer and a goldlayer for ASP Gold)	needle : surgical stainless steelhandle : plastic
Labeling	IDENTIFICATIONManufacturer name and addressProduct nameAcupuncture needlesQuantityLot NumberSTATEMENTS"STERILE""Use before""Sterilized by gamma radiation""For single use""Do not reuse""Rx" statement"Do not store at extreme temperatures andhumidity""Do not use if external package has beendamaged or blisters previously opened""Made in France"	IDENTIFICATIONManufacturer name and addressProduct nameAcupuncture needlesGauge, lengthQuantityLot NumberSTATEMENTS"STERILE""EXPIRY""Sterilized with Ethylene oxide gas""For single use only""Rx" statement"Do not store at extreme temperatures andhumidity""Do not use if package is previously opened ordamaged"Made in Japan"

9. Equivalency Comparison Table:

Based on the design, function, intended use and materials of the DN Needles, substantial equivalence is evident. The referenced CARBO brand needles are functionally identical. The anticipated safety and effectiveness of both devices is or may be expected to be the same.

SEDATELEC ASP Needles

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

SEDATELEC C/O Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 94523-3389 Pleasant Hill, Caliornia

Re : K983798 ASP Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX Dated: July 8, 1999 Received: July 12, 1999

Dear Mr. Schlerf

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Schlerf

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 markeed problems, 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation 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 che regulation chereida, "MaxPanding II" other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page 1 of of 1 ---------

K 983798

Device Name(s):

:510(k) Number:

ASP - Acupuncture Needles

Indications for Use:

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Pallace Crescenti
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 4983798 510(k) Number _

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

SEDATELEC ASP Needles

Regulation Number and Section

§ 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.