The provided text describes the submission of a 510(k) premarket notification for a medical device called the "TruView Light Cable" and its variants. This document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Instead, it focuses on the substantial equivalence of a physical medical device (a fiber optic light cable) to existing predicate devices.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.

However, the document does contain information about performance testing for the physical device. Here's a breakdown of the relevant information provided:

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

The document states that the TruView Light Cable was subjected to three performance tests and "met the acceptance criteria for the testing performed." While specific numerical acceptance criteria and performance values are not explicitly detailed in a table, the document lists the types of tests and their purpose:

Test Name	Purpose	Reported Performance
Fit Test	To show that the cable is compatible with the retractor.	Met acceptance criteria.
Collateral Heating Test	To show that the cable, when used with the identified light source, does not pose a risk to the surgeon or operating room users (burn/injury to user).	Met acceptance criteria.
Intensity Test	To show that the cable, when used with the identified light source and the worst-case retractor blade configuration, does not pose a risk to the patient (burn/patient injury).	Met acceptance criteria.

2. Sample sizes used for the test set and the data provenance:

Sample Size: Not specified. The document simply states "three (3) performance tests." It does not indicate the number of units tested for each performance test.
Data Provenance: Not specified regarding "country of origin of the data" or "retrospective/prospective." This testing would typically be prospective, in-house laboratory testing of the manufactured devices.

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 a physical device performance test, not a diagnostic algorithm requiring expert interpretation of medical images or data. Ground truth would be defined by engineering specifications and objective measurements (e.g., temperature, fit, light intensity).

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

Not Applicable. See point 3.

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 diagnostic 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):

For a physical device like a light cable, the "ground truth" would be established by engineering specifications, regulatory standards, and objective measurements.
- For the Fit Test: Successful mechanical coupling and operation.
- For the Collateral Heating Test: Temperature measurements staying below defined safety thresholds for burns.
- For the Intensity Test: Light intensity measurements meeting efficacy requirements while staying below defined thresholds to prevent patient injury.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML model that requires a training set.

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

Not Applicable. See point 8.

Summary

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June 30, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Innovasis, Inc. Marshall Mccarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K200874

Trade/Device Name: TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: FST Dated: March 31, 2020 Received: April 1, 2020

Dear Marshall Mccarty:

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

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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 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 (OS) 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,

Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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)

Device Name TruView™ Light Cable

Indications for Use (Describe)

The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font.

510(k)

5.0 510(k) Summary Report:

TruView™ Lateral Retractor Light Cable

Company:	Innovasis, Inc.
	614 E. 3900 South
	Salt Lake City, UT 84107

Contact: Marshall C. McCarty Phone: (801) 261-2236 x8012 mmccarty@innovasis.com
Trade Name: TruView Light Cable
Common Name: Fiber Optic Light Cable
Classification: Requlation No.: 21 CFR 878.4580 Class 2 Product Code: FST Review Panel: General & Plastic Surgery
Primary Predicate: K042034 NuVasive, Inc. MaXcess Light Guide This predicate has not been subject to a design-related recall.

Additional Predicate:

K901035

Cuda Products Co./Sunoptic Technologies Fiberoptic Light Cable

Device Description: The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.
Performance Data: (Non-clinical)—The TruView Light Cable was subjected to three (3) performance tests that indicated it performs in accordance with its intended use. Testing included a Fit Test to show that it is compatible with the retractor; a Collateral Heating Test to show that the cable, when used with the identified light source, does not pose a risk to the surgeon or operating room users (burn/injury to user); and an Intensity Test to show that the cable, when used with the identified light source and the worst-case retractor blade configuration, does not pose a risk to the patient (burn/patient injury).

The subject TruView Light Cable met the acceptance criteria for the testing performed.

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Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern.

Materials: The TruView Light Guide contains borosilicate glass optical fibers wrapped in a silicone sheath and has surgical stainless-steel couplings per ASTM F899.

The TruView sterilization trays are comprised of Anodized 5052 Aluminum and have components made of Nylon, Stainless Steel, Polypropylene, and RADEL per ASTM D6394 SP031.

Indications for Use: The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.

Comparison of Technological Characteristics with the Predicate Devices:

The TruView Light Cable has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate devices, NuVasive MaXcess Light Guide (K042034) and Sunoptic Fiberoptic Light Cable (K901035).

Technology is substantially equivalent. -
Design is substantially equivalent. —
-Size is substantially equivalent.
Indications for use (intended use) are substantially ー equivalent.
Materials (biocompatibility profile) are substantially equivalent.
Conclusion: The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.