The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.

For use in gynecological laparoscopy the following specific indications apply:

Unexplained pelvic pain (acute, chronic)
Infertility work-up
Tubal sterilization
Diagnosis and/or treatment of ectopic pregnancy
Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)
Evaluation of congenital anomalies of the pelvic organs
Retrieval of foreign bodies
Determination of the presence and extent of pelvic endometriosis
Determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
Access to abdomen for surgical procedures such as LAVH
Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) organs

Device Description

The Smith & Nephew Dyonics 2.7mm Microlaparoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design.

AI/ML Overview

This 510(k) premarket notification for the Smith & Nephew Dyonics 2.7mm Microlaparoscope does not contain specific acceptance criteria or a study demonstrating that the device meets such criteria in the way you've outlined for performance studies (e.g., using AI, MRMC studies, sensitivity/specificity).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. This is a common pathway for medical devices where the manufacturer shows that their new device is as safe and effective as a legally marketed device (the predicate).

Here's why your requested information isn't present in this document:

Type of Device: The Dyonics 2.7mm Microlaparoscope is an optical instrument used for visualization and access during surgery, not a diagnostic algorithm or AI-powered device. Performance criteria for such devices typically revolve around optical quality, biocompatibility, sterilization efficacy, mechanical integrity, and safety. These are usually assessed through engineering tests, material testing, and sometimes simulated use or compatibility studies, rather than clinical studies with sensitivity/specificity metrics.
Regulatory Pathway: The 510(k) pathway for substantial equivalence often relies on comparing the new device's technological characteristics and intended use to a predicate device that has already established its safety and effectiveness. This often doesn't require new clinical performance studies unless there are significant differences that raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer most of your detailed questions related to acceptance criteria, sample sizes, expert ground truth, or MRMC studies, as the provided document does not contain this type of information.

What the document does provide regarding "acceptance criteria" (implicitly equivalence):

The "acceptance criteria" in this context is the demonstration of substantial equivalence to the predicate device, the Richard Wolf Medical 2.0mm mini laparoscope, in terms of:

Design
Materials
Function
Intended Use

The "study" proving this is a comparison of technological characteristics between the Dyonics 2.7mm Microlaparoscope and the Richard Wolf Medical 2.0mm mini laparoscope.

Based on the provided document, here's what can be extracted, addressing your points where possible, and explaining why others are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the document)
Design Equivalence (to predicate)	"substantially equivalent in design"
Materials Equivalence (to predicate)	"substantially equivalent in materials"
Function Equivalence (to predicate)	"substantially equivalent in function"
Intended Use Equivalence (to predicate)	"substantially equivalent... and intended use"
Optical Functionality	"transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design." (Descriptive, not a performance metric)
General Laparoscopy Indications	Indicated for use in general laparoscopy to provide access, illumination, visualization, manipulation of body cavities, hollow organs, canals.
Gynecological Laparoscopy Indications	Indicated for specific gynecological procedures (e.g., unexplained pelvic pain, infertility work-up, tubal sterilization, etc.).

2. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't present a test set in the context of a performance study to generate sensitivity/specificity. The "test" is the comparison against the predicate device's characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic performance (e.g., disease presence) is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate device.

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-powered device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) submission is the pre-existing regulatory clearance and established safety and effectiveness of the predicate device (Richard Wolf Medical 2.0mm mini laparoscope). The Dyonics Microlaparoscope is deemed safe and effective because it is substantially equivalent to this already approved device.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

Summary

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K982149

SEP 1 0 1998

510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics 2.7mm Microlaparoscope

Substantial Equivalence:

The Smith & Nephew Dyonics 2.7mm Microlaparoscope is substantially equivalent in design, materials, function, and intended use to the Richard Wolf Medical 2.0mm mini laparoscope.

Predicate Device:

The predicate device for this submission is the Richard Wolf Medical 2.0mm mini laparoscope.

Summary of Device Function:

The Smith & Nephew Dyonics 2.7mm Microlaparoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design.

Intended Use of Device:

For use in gynecological laparoscopy the following specific indications apply:

Unexplained pelvic pain (acute, chronic) ●
Infertility work-up ●
Tubal sterilization ●
Diagnosis and/or treatment of ectopic pregnancy ●
Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma . (less than 16 weeks gestational size)
Evaluation of congenital anomalies of the pelvic organs
. Retrieval of foreign bodies
. Determination of the presence and extent of pelvic endometriosis
Determination of the presence and extent of pelvic inflammatory disease . (if not in acute stage)
Access to abdomen for surgical procedures such as LAVH .
Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs

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Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Dyonics 2.7mm Microlaparoscope is substantially equivalent in materials, design and function to the Richard Wolf Medical 2.0mm mini laparoscope.

Welsh J. Coman

Deborah J. Connors Sr. Regulatory Affairs Specialist

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's seal, which includes an emblem of three stylized human profiles facing right, arranged in a stacked formation. The words "DEPARTMENT OF HEALTH & HU..." are arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10 1998

Ms. Deborah J. Connors Senior Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, MA 01810

Re: K982149 Dyonics 2.7mm Microlaparoscope Dated: August 27, 1998 Received: August 28, 1998

21 CFR 884.1720/Procode: 85 HET

Regulatory Class: II

Dear Ms. Connors:

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 of 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 (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 equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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%) 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 regulation 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/cdrb/dsmamain.html", -

Sincerely vours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982149 510(k) Number :

Device Name : Smith & Nephew, Inc., Endoscopy Division Dyonics Microlaparoscope

Indications for Use :

For use in gynecological laparoscopy the following specific indications apply:

Unexplained pelvic pain (acute, chronic) .
Infertility work-up ●
. Tubal sterilization
Diagnosis and/or treatment of ectopic pregnancy .
. Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C. Szyrm

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices Devices

510(k) Number K982149

ption Use OR Over-the-Counter

Prescription Use V (Per 21 CFR 801.109) Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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For use in gynecological laparoscopy the following specific indications apply: (cont'd)

Evaluation of congenital anomalies of the pelvic organs .
. Retrieval of foreign bodies
Determination of the presence and extent of pelvic endometriosis .
Determination of the presence and extent of pelvic inflammatory disease (if . not in acute stage)
Access to abdomen for surgical procedures such as LAVH .
Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.