KleenSpec® Single Use Vaginal Speculum: The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal speculum can be used with or without the illuminator. KleenSpec® 790 Series Cordless Illuminator: When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source.

Device Description

The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator. When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source.

AI/ML Overview

This 510(k) Premarket Notification for the Welch Allyn KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System does not contain the level of detail requested for acceptance criteria and a comprehensive study description as it applies to an AI/ML device.

This document is a submission for a traditional medical device (vaginal speculum and illuminator) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use, rather than detailed performance metrics derived from clinical studies with ground truth establishment in the way an AI/ML device would need. The FDA letter confirms the device is substantially equivalent to a predicate device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is what can be inferred or explicitly stated from the document, along with explanations for the missing information:

Acceptance Criteria and Device Performance for Welch Allyn KleenSpec® Single Use Vaginal Speculum and 790 Series Cordless Illumination System (K070964)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Expected Performance)	Reported Device Performance (Achieved)
Premarket Clearance	Substantial Equivalence to Predicate	Achieved (FDA determined substantial equivalence to KleenSpec Disposable Vaginal Speculum 580 series (K941272))
Intended Use	Dilate vagina, expose interior, provide illumination for pelvic exams and other gynecological procedures.	The device meets this intended use, functioning as a non-metal vaginal speculum and a cordless illuminator for the specified medical procedures.
Safety & Effectiveness	Implied to be similar to predicate device (no new safety/effectiveness concerns).	Not explicitly detailed in performance metrics, but implicit in the substantial equivalence determination.
Functionality	Basic function of a vaginal speculum and illuminator.	Functions as described (dilates vagina, provides illumination).

Explanation for Missing Information:
For a traditional medical device like this, acceptance criteria primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The 510(k) summary does not include specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) derived from controlled studies, which are typically required for AI/ML devices.

Study Information Pertaining to K070964

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The submission is for a physical medical device, not an AI/ML algorithm. There is no "test set" in the context of an algorithm's classification or prediction performance. The "test" for substantial equivalence often involves comparing design specifications, materials, and intended use to a predicate device.
Data Provenance: Not applicable. There is no data provenance in the context of clinical data used for AI/ML model evaluation.

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

Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of device submission.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There is no test set in the context of AI/ML evaluation, and thus no adjudication method for ground truth.

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. This is not an AI/ML device; therefore, no MRMC study comparing human readers with and without AI assistance would have been performed or would be relevant.

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

Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable. Ground truth, in the context of AI/ML, refers to the verified correct answer against which an algorithm's output is compared. This concept does not apply to a physical device like a speculum or illuminator. The "truth" for this device relates to its physical properties, biocompatibility, and functional performance matching its intended use and predicate device.

8. The sample size for the training set

Sample Size: Not applicable. There is no AI/ML model to train.

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

Ground Truth Establishment: Not applicable.

Summary of Device and 510(k) Context:

This 510(k) submission (K070964) is for a physical medical device: a vaginal speculum and a cordless illumination system. The submission's purpose is to demonstrate substantial equivalence to an existing legally marketed device (the KleenSpec Disposable Vaginal Speculum 580 series, K941272).

For such devices, the "acceptance criteria" are primarily related to:

Meeting the same intended use as the predicate device.
Having similar technological characteristics (e.g., materials, design principles).
Raising no new questions of safety or effectiveness.
Conforming to relevant performance standards (though not explicitly detailed in this summary).

The 510(k) mechanism is a premarket notification process for medical devices that do not require a Premarket Approval (PMA) application. It is fundamentally different from the regulatory pathway for AI/ML-driven devices, which would necessitate extensive data sets, ground truth establishment, and performance metrics like sensitivity, specificity, AUC, and studies evaluating human-AI interaction.

Summary

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

K070964 plot

WelchAllyn

Special 510(k) Premarket Notification KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System

14. Premarket Notification [510(k)] Summary

MAY 1 8 7007 Submitted By: Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 Phone: (315) 685-4571 (315) 685- 2532 Fax: Contact: John E. Sawyer, Vice-President, Quality Assurance & Regulatory Affairs

Common Name: speculum, vaginal, nonmetal
Trade Name: KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System (Special 510(k))
Classification: 21 CFR § 884.4530; Class II
KleenSpec Disposable Vaginal Speculum 580 series (K941272) Predicate Device:
Description: The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator.
When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source.
Intended Use: KleenSpec® Single Use Vaginal Speculum
The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.

The vaginal speculum can be used with or without the illuminator.

KleenSpec® 790 Series Cordless Illuminator

When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other

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

KC7Dx., 2 of 2

Velch Allyn

Special 510(k) Premarket Notification KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System

gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.

The illuminator can be used independent of the speculum as a general-purpose light source. 。

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 1 8 2007

Chris Horacek VP and Associate General Counsel Welch Allyn, Inc. 4341 State Street Road SKANEATELES FALLS NY 13153-0220

Re: K070964

Trade/Device Name: KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: April 4, 2007 Received: April 5, 2007

Dear Mr. Horacek:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a bold, stylized font, with the word "Centennial" underneath. Three stars are arranged below the word "Centennial". The text "PROTECTING AND PROMOTING YOUR HEALTH" is arranged around the circle.

Protecting and Promoting Public Health

{3}------------------------------------------------

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.

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Welch Allyn

Special 510(k) Premarket Notification KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System

13. Statement of Indications For Use

510(k) Number (if known):	K070964
Device Name:	KleenSpec® Single Use Vaginal Speculum and 790 seriesCordless Illumination System

Indications For Use:

KleenSpec® Single Use Vaginal Speculum

The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.

The vaginal speculum can be used with or without the illuminator.

KleenSpec® 790 Series Cordless Illuminator

When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.

The illuminator can be used independent of the speculum as a general-purpose light source.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Nancy C. Brogdon
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K070964

Section 13 – Page 1 of 1

MPD FCD-0026, Rev. 2

Section 13 Page I of I This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.