The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.

Device Description

The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:

Left and right orientation guides with 5°-15° of angulation
Fixation pins, 12-16mm
Drills, 2-6mm Diameter x 10-18mm Depth
Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
Guide Pin Adapter
Guide Pins
Quick Disconnect Handle
Fixation Pin Driver
Tamp
Mallet

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Transcorp Spinal Access System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The review process for 510(k) devices focuses on demonstrating substantial equivalence, rather than establishing de novo safety and effectiveness through extensive clinical trials.

Therefore, the information for acceptance criteria and a study proving the device meets those criteria will be framed within the context of a 510(k) submission and the concept of "substantial equivalence."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance
Similar Technological Characteristics: Device should have similar design, materials, and intended function to the predicate device.	The Transcorp Spinal Access System shares the same technological characteristics, including the types of instruments included, the material (stainless steel), and the function as the predicate system (TranS1 Trans-Sacral Spinal Access and Preparation K032891). It includes components like orientation guides, fixation pins, drills, guide pins, and handles, similar to what would be expected for a spinal access system.
Similar Intended Use: Device should have the same intended purpose as the predicate device.	The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone. This is consistent with the general function of spinal access systems, implying a similar intended use to its predicate.
Non-Clinical Performance: Device should perform at least as safely and effectively as the legally marketed predicate device, as demonstrated through non-clinical testing.	"Cadaver performance testing, functional testing, and comparison to the predicate demonstrated that the Transcorp Spinal Access System can be used in accordance with the Indications for Use." The conclusion states: "Nonclinical tests demonstrate that the Transcorp Spinal Access System is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device."
Safety and Effectiveness (comparative): The device is as safe and effective as the predicate.	The FDA letter confirms: "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... to legally marketed predicate devices." This is the core finding of a 510(k) process – that the device meets the substantial equivalence standard.

Regarding the Study (or evidence) that proves the device meets the acceptance criteria:

The primary "study" described is a Non-Clinical Testing Summary, which included:

Cadaver performance testing: This type of testing would assess the device's ability to be used successfully in a simulated surgical environment (on cadavers) for its intended purpose (minimally invasive access to the anterior spine).
Functional testing: This likely involved benchtop tests to evaluate the physical and mechanical properties of the instruments (e.g., strength of drills, accuracy of guides, durability of materials).
Comparison to the predicate: This involved direct comparison of the Transcorp system's features, materials, and performance against the legally marketed predicate device (TranS1 Trans-Sacral Spinal Access and Preparation K032891) to demonstrate similarity and equivalent performance.

The conclusion drawn from this non-clinical testing was that the Transcorp Spinal Access System is "as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device." This finding enables the FDA to determine that the new device is "substantially equivalent" to an already marketed device, which is the "acceptance criteria" for a 510(k) submission.

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

Sample Size: The document explicitly mentions "Cadaver performance testing." While it confirms cadavers were used, it does not specify the number of cadavers used for the performance testing.
Data Provenance: Not specified, but generally, cadaver studies for medical device testing are conducted in controlled laboratory environments. The country of origin for the data is not mentioned. The description of testing indicates a prospective assessment of the device.

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)

The document does not specify the number or qualifications of experts involved in establishing any "ground truth" for the non-clinical tests. For cadaver and functional testing, it's typically engineers, surgeons, or anatomists who evaluate performance, but their specific involvement and qualifications are not detailed. In the context of a 510(k), the "ground truth" is largely the performance of the predicate device.

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

The document does not mention any adjudication method as it relates to expert review or consensus for the non-clinical tests. Such methods are typically relevant for clinical studies or image interpretation tasks, which are not detailed here.

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

No MRMC comparative effectiveness study was done. This type of study (MRMC) is generally performed for diagnostic imaging devices involving human interpretation, often when Artificial Intelligence (AI) is involved to assess its impact on reader performance. The Transcorp Spinal Access System is an instrument system, not a diagnostic imaging device with AI assistance.

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

Not applicable. The Transcorp Spinal Access System is a set of surgical instruments, not an algorithm or software-only device. Therefore, a standalone performance assessment in the context of "algorithm only" is not relevant.

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

For this type of device and submission, the "ground truth" is effectively:
- Functional performance standards: Whether the instruments perform their intended mechanical actions (e.g., drills cut, guides guide).
- Cadaveric anatomical access: Whether the system allows appropriate visualization and access to the anterior spine in cadaver models.
- Comparison to predicate: The established safe and effective performance of the legally marketed predicate device upon which substantial equivalence is based.

8. The sample size for the training set

Since the submission is based on non-clinical testing and comparison to a predicate, and there is no mention of an algorithm or machine learning component, there is no "training set" in the conventional sense (e.g., for AI model development).

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

As there is no training set for an algorithm, this question is not applicable.

Summary

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11/3352

510(k) Summary Pursuant to 21 CFR 807.92c

Submitted By:

Andrew Rodenhouse Transcorp, Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-855-5375 Fax: 616-877-4522

Date:

March 29, 2012

Device Information:

Transcorp Spinal Access System Trade Name:

Common Name: Rigid Endoscope and Instrument Set

21 CFR Section 888.1100, Arthroscope Product Classification: Code: HRX

Substantially Equivalent Device:

TranS1 Trans-Sacral Spinal Access and Preparation K032891: Device

Device Description:

The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:

Left and right orientation guides with 5°-15° of angulation
Fixation pins, 12-16mm
Drills, 2-6mm Diameter x 10-18mm Depth
Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
Guide Pin Adapter

TransCorp Spinal Access System 510(k) Premarket Notification

Page 5.2
CONFIDENTIAL

1/2

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Guide Pins ●
Quick Disconnect Handle .
Fixation Pin Driver
Tamp .
Mallet .

Intended Use:

Comparison to Predicate:

The Transcorp Spinal Access System and the predicate device include similar stainless steel instruments used in accessing the spine. The Transcorp Spinal Access Systems shares the same technological characteristics including the types of instruments included, the material, and the function as the predicate system.

Summary of Non Clinical Testing:

Cadaver performance testing, functional testing, and comparison to the predicate demonstrated that the Transcorp Spinal Access System can be used in accordance with the Indications for Use.

Conclusion

Nonclinical tests demonstrate that the Transcorp Spinal Access System is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device.

TransCorp Spinal Access System 510(k) Premarket Notification

ನ್ನಾಗಿ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Transcorp, Inc. % Mr. Andrew Rodenhouse 1000 100th Street SW, Suite F Byron Center, Michigan 49315

Re: K113352

Trade/Device Name: Transcorp Spinal Access System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 30, 2012 Received: March 30, 2012

Dear Mr. Rodenhouse:

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. 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 r reaso be as nove a determination that your device complies with other requirements of the Act that + Drivel 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

APR 1 6 2012

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Page 2 - Mr. Andrew Rodenhouse

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Mark N. Mullen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

KI13352

Transcorp Spinal Access System Device Name:

Indications for Use:

X Prescription Use_ (per CFR 801.109)

Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Dyke for mxm
(Division Sign-Off)

ੀ।

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113352

Page 4.2 CONFIDENTIAL

TransCorp Spinal Access System 510(k) Premarket Notification

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.