The Akro-Vu Videoscopic Carpal Tunnel Release System (VCTR) is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e. idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a capal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e. calcific tendonitis, fracture of the hook of the hamate). This device is indicated solely for releasing the flexor retinaculum (transverse carpal lig ament).

Device Description

The AKRO-VU Videoscopic Carpal Tunnel Release System (VCTRS) is designed as a stand-alone platform to address less invasive surgical approaches for Carpal Tunnel Release procedures performed by trained physicians. The AKRO-VU VCTRS is comprised of a reusable Video-Monitor with Li lon Battery and Charger, an autoclavable Sterile Enclosure with Base Stand to house the Video-Monitor within the sterile field, an autoclavable Handle with cable assembly and Locking Ring, and two styles of single use disposable Video-Blades each containing a camera, light source and deployable blade. The AKRO-VU VCTRS is designed to be a battery powered system.

AI/ML Overview

The Akro-Vu Videoscopic Carpal Tunnel Release System (VCTRS) is a medical device designed for less invasive surgical approaches to Carpal Tunnel Release procedures. The submission K092723 focuses on establishing its substantial equivalence to a predicate device, the Microaire CTRS / 3M Inside Job (K912871). The acceptance criteria for this device are primarily based on performance testing demonstrating its safety and effectiveness, and comparability to the predicate device in terms of indications for use, design, materials, and operating principles.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Microbial Barrier (Sterile Enclosure)	Enclosure must provide an effective microbial barrier.	The enclosure was found to be an effective microbial barrier.
Blade Sharpness	Blade edge radius should be comparable to the predicate device.	Comparative analysis indicated both blades (subject and predicate) were comparable in sharpness.
Visualization Capabilities	Video imaging capabilities should be focused, illuminated, and discernible within specified ranges.	Visualization testing showed the target image displayed was focused, illuminated, and discernible within the specified ranges.
Battery Capacity	Fully charged battery must power the system for a sufficient duration.	System power-on time exceeded the capacity requirement by a safety factor of 11.
Temperature Rise (VideoBlade)	Temperature at the distal end of the Videoblade should not rise beyond a specified limit (e.g., 1°C) after 30 minutes of use at full power.	The temperature of the Videoblades tested after 30 minutes of use did not rise more than 1°C.
Blade Actuation	Blade must actuate smoothly throughout its range and return to a sub-flush position after repeated actuations against a force.	After cyclic testing, all test samples actuated smoothly throughout the entire range, and the blade returned to a position sub-flush to the edge of the housing.
Cut Force	The cutting force of the Videoblade must be within specified limits on test media and provide necessary cut force on cadaver tissue.	The results indicated that the blades cut the test media within the required force parameters. The blade was found to provide the necessary cut force on cadaver tissue.
Strength (Videoblade)	Videoblade must withstand typical loads (torsional, posterior cantilever, lateral cantilever forces) during use, meeting stiffness and strength specifications.	Test results concluded that all test samples met the stiffness and strength specifications for torsional, posterior cantilever, and lateral cantilever forces.
Substantial Equivalence	Device must be substantially equivalent to the predicate device, with similar indications for use, basic shape, materials, and operating principles.	The device meets these criteria, leading to a conclusion of substantial equivalence based on performance testing and comparative analyses.

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

The document does not specify exact "sample sizes" in terms of number of patients or specific image datasets, as this is a submission for a surgical instrument, not a diagnostic AI system or a drug. The "test set" for this device consists of various physical tests performed on the device components.

For physical tests like blade actuation, temperature, cut force, and strength, the sample size would refer to the number of device units or components tested. While not explicitly stated, the phrasing "all test samples" suggests multiple units were used for each test. For example, "After cyclic testing, all test samples actuated smoothly..." indicates more than one sample was subjected to the cyclic test.
Data Provenance: The tests performed are laboratory-based, in-vitro (e.g., microbial barrier, temperature, strength tests on materials), and ex-vivo (cadaveric evaluations for cut force on tissue). Therefore, the "country of origin of the data" is primarily the testing facility of Skeletal Dynamics, LLC or their contracted labs. The data is prospective in the sense that these tests were specifically performed for this device submission to evaluate its characteristics.

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

This type of submission for a surgical instrument does not involve establishing ground truth through expert review of medical images or patient outcomes in the same way an AI diagnostic tool would. The "ground truth" for these performance tests is based on established engineering standards, material science properties, and biological functionality (e.g., what constitutes an "effective microbial barrier," what "necessary cut force on cadaver tissue" means in a surgical context, acceptable temperature rise, etc.). These standards are typically defined by:

Engineers and Technicians: Qualified personnel with expertise in mechanical testing, material science, and medical device design.
Surgeons/Clinical Experts: While not explicitly mentioned as "establishing ground truth" for specific test results, the design and performance criteria would have been informed by surgical requirements, likely with input from surgeons who perform carpal tunnel release procedures. The "cadaveric evaluations" were performed to assess cut force on tissue, implying a clinical relevance check, likely interpreted by individuals with anatomical and surgical knowledge.

The document does not specify the number or detailed qualifications (e.g., "radiologist with 10 years of experience") of such experts, as it's not relevant to this type of device submission.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device and its testing. Adjudication methods like "2+1" or "3+1" are typically used for disagreements in human expert interpretations of medical data (e.g., reading scans for an AI diagnostic study). For performance tests of a surgical instrument, the results are typically quantitative measurements that either meet or do not meet a predefined specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are characteristic of diagnostic imaging AI systems where multiple human readers interpret medical cases with and without AI assistance to measure the AI's impact on diagnostic performance. This submission is for a surgical instrument, not a diagnostic tool, and therefore, such a study design is not applicable.

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

Yes, the various performance tests are essentially "standalone" evaluations of the device's physical and functional characteristics. The "device performance" reported in the table above refers to the intrinsic performance of the Akro-Vu VCTRS itself, without a human operator's performance being assessed or factored into the results of these specific tests. For example, the battery capacity test measures how long the system powers on, not how long a surgeon can operate with it.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed can be categorized as:

Engineering Specifications/Standards: For tests like blade actuation, temperature rise, strength, and cut force on test media, the ground truth is defined by pre-established engineering specifications and industry standards for medical devices of this type.
Comparative Analysis: For blade sharpness, the ground truth is established by direct comparison with the legally marketed predicate device, Microaire CTRS / 3M Inside Job (K912871).
Biological/Anatomical Functionality: For cadaveric evaluations of cut force on tissue, the ground truth relates to the device's ability to effectively perform its intended surgical function (releasing the flexor retinaculum) on human tissue.
Functional Effectiveness: For microbial barrier and visualization tests, the ground truth is whether the system performs its designed safety and functional roles effectively (e.g., "effective microbial barrier," "focused, illuminated and discernible image").

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a "training set." The device is a physical surgical instrument.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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UCT 4 2010

K092723

510(k) Summary of Safety and Effectiveness Akro-Vu Videoscopic Carpal Tunnel Release System

May 5, 2010

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: (305) 596-7585 Contact: Ana M. Escagedo / Vice President Quality & Requlatory Affairs Email: aescagedo@skeletaldynamics.com

FDA Establishment Registration Number: Pending

Trade Name, Common Name, Classification:

Device Trade Name: Akro-Vu Videoscopic Carpal Tunnel Release System Akro-Vu VCTRS

Device Common or Usual Names: Carpal Tunnel Release device, Arthroscope. Knives, Sheaths. Arthroscopic Cutting Instrument

Classification: Class II, 21 CFR 888.1100

Predicate Device:

Microaire CTRS / 3M Inside Job - K912871

Description of the Device:

Intended Use:

The Akro-Vu Videoscopic Carpal Tunnel Release System (VCTR) is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any

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other known pathology (i.e. idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e. calcific tendonitis, fracture of the hook of the hamate). This device is indicated solely for releasing the flexor retinaculum (transverse carpal ligament).

Contraindications

The device is not intended for use in patients with known abnormalities of their wrist (carpal tunnel), including distal radial deformities, rheumatoid and other synovitis.

Technological Characteristics:

The Akro-Vu Videoscopic Carpal Tunnel Release System has the following similarities to the Microaire CTRS manufactured and distributed by Microaire pursuant to K912871:

. The same indications for use and intended use
The same basic general shape of the working instrument .
Utilize the same materials for the blade and the housing of the working . instrument
. Use the same operating principals

Biocompatibility:

The materials selected for the Akro-Vu Videoscopic Carpal Tunnel Release System have a long history of safe use in the orthopedic industry. The materials include Stainless Steel, Ultem, Parylene, Polycarbonate, and Cyclo Olefin Polymer, and Silicone Rubber.

Summarv:

The following safety and performance tests were performed in support of the submission:

· An assessment of the microbial barrier of the Sterile Enclosure was performed to evaluate the effectiveness of the barrier. The enclosure was found to be an effective microbial barrier.
· A comparative analysis of the blade (subject vs. predicate) was made to evaluate the edge radius for sharpness. The results indicate that both blades were comparable. Visualization testing was performed to test the video imaging capabilities of the system. The target image displayed was focused, illuminated and discernable within the specified ranges.
· A battery capacity test was performed to determine how long a fully charged battery would power the system. The system power on time exceeded the capacity requirement by a safety factor of 11.
· Temperature testing was done to determine the temperature at the distal end of the Videoblade at full power after 30 minutes of use. The temperature of the Videoblades tested after 30 minutes of use did not rise more than 1°C.
A blade actuation test was performed to confirm the blade actuated after repeated actuations against a force. After cyclic testing, all test samples actuated smoothly throughout the entire range and the blade returned to a position sub-flush to the edge of the housing.

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Cut force testing was performed to confirm the cutting force of the Videoblade . was within specified limits. The results indicated that the blades cut the test media within the required force parameters. Cadaveric evaluations of the blade were also performed to evaluate cut force on tissue. The blade was found to provide the necessary cut force on cadaver tissue.
· A series of strength tests were done to evaluate the Videoblade's ability to withstand typical loads during use. The test results concluded that all test samples met the stiffness and strength specifications for torsional, posterior cantilever, and lateral cantilever forces.

Conclusion:

Based on the performance testing and the comparative analyses, we believe the subject device performs as intended and is substantially equivalent to the predicate device. Therefore, we conclude that the subject device is safe and at least as effective as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

OCT 4 2010

Skeletal Dynamics, LLC % Orchid Design Mr. Joseph M. Azary 80 Shelton Technology Center Shelton, Connecticut 06484

Re: K092723

Trade/Device Name: Akro-Vu Videoscopic Carpal Tunnel Release System (VCTR) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 17, 2010 Received: September 20, 2010

Dear Mr. Azary:

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 Foond, Orve 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 linbility 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

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Page 2 - Mr. Joseph M. Azary

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/CDRH0ffices/ucm1118001/ppnflast 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/ReportaProblem/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 Dalmperdit

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

510(k) Number (if known): K092723

Device Name: Akro-Vu Videoscopic Carpal Tunnel Release System (VCTR)

Indications For Use:

Contraindications: The device is not intended for use in patients with known abnormalities of their wrist (carpal tunnel), including distal radial deformities, rheumatoid and other synovitis.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RPDaben for mxm

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K092723

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.