MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.

Device Description

The MectaScope System is comprised of rigid scopes use to examine joints, a sheath used to access the surgical site, and obturators to facilitate the initial access of the sheath into the joint cavity in preparation for arthroscopic procedures.

The rigid scopes, manufactured primarily from stainless steel, provide a circular field of view and are available in two (2) different directions of view, 30° and 70°. The sheath, manufactured from stainless steel and EPDM, is introduced into the joint using the obturators and maintains a stable portal during the arthroscopic procedure. The obturators, manufactured with stainless steel and EPDM, are provided with or without a handle; the obturator with a handle is compatible with a Ø 1.5 mm k-wire. The MectaScope System components are provided non-sterile and are reusable.

The MectaScope scopes are designed to be used with legally marketed camera and control units and are connected to legally marketed available light-guide cables via the light connector (designed in accordance with ISO 18339). Manufacturer specific light guide adapters are provided with the MectaScope System including adapters for Olympus/Storz, Richard Wolf, and ACMI light guide cables.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the "MectaScope System," an arthroscope. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a clinical trial or extensive standalone performance study as would be seen for novel AI/software devices.

Therefore, many of the typical questions for AI/software device acceptance criteria and studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, effect sizes, etc.) are not directly applicable or detailed in this type of submission because the MectaScope System is a physical medical device (an arthroscope) and not a software-driven diagnostic or AI prediction tool. The performance data presented focuses on mechanical integrity and functional comparison to the predicate device, not diagnostic accuracy in the way an AI would be evaluated.

Here's an attempt to answer your questions based only on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Study for the MectaScope System

Based on the provided FDA 510(k) summary, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a physical medical device (arthroscope) rather than an AI/software device. The focus is on comparing the MectaScope System's functional performance and characteristics to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table with specific numerical acceptance criteria alongside reported performance for each criterion. Instead, it describes general categories of testing and asserts that "Design verification testing was undertaken and demonstrates that the subject device performs to specification and as intended." And that "Testing was conducted according to written protocols with acceptance criteria that were based on standards."

However, we can infer some "performance" points from the "Comparison of Technological Characteristics" and "Performance Data" sections.

Acceptance Criterion (Inferred from testing)	Reported Device Performance (as stated in document)
Maintain visual field and viewing direction as per ISO 8600	"visual field and viewing direction testing per ISO 8600" (Passed implicitly, as substantial equivalence was claimed)
Meet concentricity requirements as per ISO 18339	"concentricity test per ISO 18339" (Passed implicitly)
Compatible with predicate's fluid passage mechanism for sheath (comparison study)	Performed a comparative study of "fluid passage (volume unit per time) with the MectaScope Rotating Sheath and the KARLSTORZ Arthroscope Sheath" (Implied non-inferiority or equivalence)
Functionality in a simulated use environment (cadaver testing)	"cadaver testing" (Implied successful performance in a relevant clinical setting)
Efficacy of cleaning and sterilization procedures	"cleaning and sterilization validation" (Implied successful validation ensuring reusability safety)
Mechanical integrity and performance on "worst-case device configurations"	"mechanical studies were performed on worst-case device configurations" (Implied meeting desired mechanical performance)
System components provide a circular field of view	Stated as a characteristic of the rigid scopes.
Available in 30° and 70° directions of view	Stated as a characteristic of the rigid scopes.
Reusable	Stated as a characteristic of the rigid scopes.
Compatibility with legally marketed camera, control units, and light-guide cables	Stated as a design feature and demonstrated by provision of adapters.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of devices or cases. For a physical device, testing would involve a certain number of manufactured units or components. The document mentions "worst-case device configurations" were tested, implying specific representative samples.
Data Provenance: Not specified. Standard practice for device testing would be internal laboratory testing by the manufacturer. The document does not indicate country of origin for the data or whether the studies were retrospective or prospective in a clinical sense, as they are engineering/bench tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/not stated. The "ground truth" for this device's performance is based on engineering specifications, international standards (ISO 8600, ISO 18339), and functional comparisons, not on expert interpretations of medical images or diagnoses.
Qualifications of Experts: Not applicable/not stated. The performance is assessed by engineers and technicians against predefined technical standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no subjective interpretation or consensus-based ground truth required that would necessitate an adjudication method like 2+1 or 3+1. Testing is objective and quantitative (e.g., measuring dimensions, fluid flow, visual field).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is specifically designed for evaluating diagnostic accuracy of medical imaging interpretations, often involving human readers with and without AI assistance. The MectaScope System is a tool for providing magnified images for diagnostic procedures, not a diagnostic interpretation software itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the context of an AI algorithm. The "performance" refers to the physical functionality of the arthroscope itself (e.g., image quality, structural integrity, compatibility), which is inherently "standalone" in that it functions according to its design, independent of human interpretation aspects.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's performance is based on:
- Engineering Specifications: Designed performance parameters.
- International Standards: e.g., ISO 8600 for visual field, ISO 18339 for concentricity.
- Predicate Device Performance: Functional equivalence or non-inferiority compared to the legally marketed predicate device (Karl Storz Arthroscopic Telescopes).
- Functional Demonstrations: Successful performance in relevant simulated environments (cadaver testing) and under "worst-case" conditions.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical device, not an AI algorithm that undergoes "training" on a dataset. The design and manufacturing processes are iterative but do not involve a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training: Not applicable, as there is no "training set" for this type of device. The design and manufacturing are based on established engineering principles, material science, and adherence to medical device standards.

Summary

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October 1, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medacta International SA Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis. Tennessee 38118

Re: K200067

Trade/Device Name: MectaScope System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 1, 2020 Received: September 3, 2020

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Pooja Panigrahi -S

for

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200067

Device Name MectaScope System

Indications for Use (Describe)

MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory Affairs and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality and Regulatory, Medacta USA Date Prepared: January 13, 2020 Date Revised: September 29, 2020

II. Device

Device Proprietary Name:	MectaScope System
Common or Usual Name:	Arthroscope
Classification Name:	Arthroscope
Product Codes:	HRX
Regulation Number:	21 CFR 888.1100
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

Arthroscopic Telescopes, K943052, Karl Storz Endoscopy .

IV. Reference Device

KSEA Large Joint Arthroscopy Set, K963524, Karl Storz Endoscopy ●

V. Device Description

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EPDM, are provided with or without a handle; the obturator with a handle is compatible with a Ø 1.5 mm k-wire. The MectaScope System components are provided non-sterile and are reusable.

VI. Indications for Use

MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.

VII. Comparison of Technological Characteristics

The MectaScope System and the predicate device share the following characteristics:

arthroscope working length, diameter, field of view, and direction of view; .
sheath design: ●
. eyepiece design;
materials of construction; and
connection to legally marketed camera systems and light guide cables.

The MectaScope System and the predicate devices are technologically different with respect to the design of connections between system components, camera, and fiber optic cable, as well as sheath and obturator design.

A comparison of key technological features between the subject and predicate device is provided in the table below.

	MectaScope System	Arthroscopic Telescopes(K943052)
Arthroscope
Type of scope	Rigid	Rigid
Outer diameter	4 mm	4 mm
Field of view	circular	circular
Direction of view	30° and 70°	30° and 70°
Reusable	Yes	Yes

Discussion

Although slight differences in design with respect to connections and obturator design exist, these differences do not raise different questions of safety and effectiveness as the products utilizing the

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same fundamental scientific technology. Design verification testing was undertaken and demonstrates that the subject device performs to specification and as intended.

VIII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed on worst-case device configurations in support of a substantial equivalence determination:

Comparative study

. Design Validation Report, Scope and Sheath - KARL STORZ Arthroscope Sheath;
- o comparison of fluid passage (volume unit per time) with the MectaScope Rotating Sheath and the KARLSTORZ Arthroscope Sheath, utilizing a rotating spigot plane

Non-Clinical Studies:

visual field and viewing direction testing per ISO 8600; ●
concentricity test per ISO 18339;
cadaver testing; and
cleaning and sterilization validation. ●

IX. Conclusion

The information provided with this submission supports that the MectaScope System is substantially equivalent to the identified predicate device.

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.