The provided text is a 510(k) summary for a disposable vaginal speculum, not a study performing extensive testing against acceptance criteria using AI or machine learning. Therefore, most of the requested information cannot be extracted directly from this document.

However, I can provide the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify formal acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Claimed Equivalence)
Same intended use	"The Medscand disposable speculum is a single-use device to be used by a medical professional to expose the interior of a vagina." (Same as predicate)
Similar design	"The Medscand disposable vaginal speculum is substantially equivalent to the Galenica disposable vaginal speculum in terms of intended use, design, materials, and principles of operation."
Similar materials	"The Medscand disposable vaginal speculum is substantially equivalent to the Galenica disposable vaginal speculum in terms of intended use, design, materials, and principles of operation."
Similar principles of operation	"The Medscand disposable vaginal speculum is substantially equivalent to the Galenica disposable vaginal speculum in terms of intended use, design, materials, and principles of operation."
Similar dimensions	"The dimensions of the Medscand speculum are similar to those of Galenica speculum, which has been cleared by FDA."
Clinical safety and effectiveness (demonstrated by predicate)	"Galenica speculum has been in clinical use since 1984 and the Medscand speculum since 1993 (in Europe)." (Implied by equivalence to predicate and European use)

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

Not applicable. The document describes a 510(k) submission for a medical device (a speculum), not a study with a test set of data in the context of AI or data analysis. The "data provenance" mentioned is the pre-existing clinical use of a predicate device (Galenica, since 1984) and the Medscand device itself in Europe (since 1993).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI or diagnostic study. Ground truth in this context would likely refer to the established safety and effectiveness of the predicate device based on its long-term clinical use and regulatory clearance, rather than expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is mentioned.

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-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" implicitly relied upon for substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Galenica disposable vaginal speculum), based on its 14 years of clinical use at the time of submission (since 1984). The Medscand device's 5 years of clinical use in Europe (since 1993) also supports this.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model.

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

Not applicable. This is a physical medical device, not an AI model.

Summary

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DEC 2 3 1998

K 984211

510 (k) Summary

SUBMITTER'S NAME, ADDRESS, TELEPHONE / FAX NUMBERS AND CONTACT PERSON.

Tennyson P. Tse, Ph.D. President and CEO Medscand (USA) Inc. 3930 N29th Avenue Hollywood, Florida 33020 (954) 922-2557 Tel: Fax: (954) 927-6890

DATE PREPARED

Date: November 20, 1998

NAME OF DEVICE, NAME AND ADDRESS OF SPONSOR

Name of device

Easy-Spec"; Medscand disposable plastic vaginal speculum

Sponsor

Medscand (USA) Inc. 3930 N29th Avenue Hollywood, Florida 33020

COMMON OR USUAL NAME

Vaginal speculum, disposable speculum, plastic speculum

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K 984211

CLASSIFICATION NAME

Speculum, vaginal, disposable

PREDICATE DEVICE

Galenica disposable vaginal speculum

DEVICE DESCRIPTION AND INTENDED USE

The Medscand polystyrene speculum is a single-use device to be used by a medical professional to expose the interior of a vagina.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Medscand disposable vaginal speculum is substantially equivalent to the Galenica disposable vaginal speculum in terms of intended use, design, materials, and principles of operation. The dimensions of the Medscand speculum are similar to those of Galenica speculum, which has been cleared by FDA. Galenica speculum has been in clinical use since 1984 and the Medscand speculum since 1993 ( in Europe ).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1998

Tenny P. Tse, Ph.D. President and CEO Medscand (U.S.A.), Inc. P.O. Box 7733 Hollywood, FL 33081

Re: K984211

Disposable Vaginal Speculum Dated: November 20, 1998 Received: November 24, 2998 Regulatory Class: II 21 CFR 884.4530/Procode: 85 HIB

Dear Dr. Tse:

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 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). 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 III (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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510 (k) Number ( new ): < 9842 ا

Device Name:

Medscand Disposable Vaginal Speculum

Indications for Use:

The Medscand disposable speculum is intended to expose the interior of a vagina for gynecological procedures.

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: 31 GELLE LER KER KER KET PER FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
( Per 21 CFR 801.109)

Over-The-Counter-Use	_________________
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices.
510(k) Number	K 984211

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.