AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:

fracture fixation (open and closed)
pseudoarthrosis of long bones
limb lengthening (epiphyseal or metaphyseal distraction)
joint arthrodesis
infected fractures or nonunions
correction of bony or soft tissue deformities ●
correction of segmental defects. ●

Device Description

The AutoStrut G2 is comprised of control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the AutoStrut G2 motorized struts.

The MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.

AI/ML Overview

The provided text describes a medical device called AutoStrut G2 and its substantial equivalence to a predicate device, AutoStrut (K191241). However, the document does not contain information about acceptance criteria, reported device performance in those terms, or a study specifically designed to prove the device meets acceptance criteria related to clinical or diagnostic accuracy.

The "Performance Data" section lists various engineering and electrical safety tests, and mentions "Software characterization and validation," "Speed and accuracy evaluation," "Reliability, force and accuracy test," but does not explicitly state acceptance criteria or the results of these tests in a way that matches the requested output format.

Therefore, I cannot fully complete the table or the requested detailed information about a study proving the device meets acceptance criteria in the manner requested. The document focuses on demonstrating substantial equivalence through technological characteristics and bench testing, rather than a clinical performance study with defined acceptance criteria for diagnostic or treatment effectiveness.

I will fill in what information is available and indicate when requested information is not present in the provided text.

Acceptance Criteria and Device Performance

No specific acceptance criteria for clinical or diagnostic performance are provided in the document. The performance data section lists various engineering and safety tests, but does not detail numerical acceptance criteria or reported performance results in a table format for the device's functional or clinical effectiveness.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AutoStrut K191241) through technological characteristics and bench testing. The "Performance Data" section lists several types of tests conducted:

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document in this format)
Static compression (per ASTM F1541)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Static torsion (per ASTM F1541)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Static cantilever bending (per ASTM F1541)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Dynamic compression/tension (per ASTM F1541)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Electrical safety (per IEC 60601-1, IEC 60601-1-11)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
EMC testing (per IEC 60601-1-2)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Software characterization and validation	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Sterilization validation (per ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Cytotoxicity testing (per ISO 10993-5)	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Speed and accuracy evaluation	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Reliability, force and accuracy test	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)
Corrosion Test	(Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.)

Study Details

The provided document describes bench testing to demonstrate performance and substantial equivalence, not a clinical study to establish acceptance criteria for efficacy or diagnostic performance.

Sample size used for the test set and the data provenance: Not applicable, as this refers to bench testing rather than a clinical test set. The document does not specify sample sizes for the materials/devices tested in the listed engineering tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests performed are engineering and electrical safety tests, not requiring expert ground truth for clinical interpretation.
Adjudication method for the test set: Not applicable.
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, an MRMC study was not described. The device is an external fixation system with automated struts, not an AI-assisted diagnostic or interpretation tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Software characterization and validation" and "Speed and accuracy evaluation" for the device, which operates automatically. This implicitly confirms standalone algorithm (control system) performance testing was done, but details of this testing (acceptance criteria, results) are not provided. The device's function is to automatically extend motorized struts based on a pre-determined treatment plan (generated by separate software, mentioned as MAXFRAME software, and downloaded to the AutoStrut G2 control box).
The type of ground truth used: For the engineering and electrical tests, the "ground truth" would be the specifications and requirements of the ASTM, IEC, and ISO standards referenced. For the "Speed and accuracy evaluation" and "Reliability, force and accuracy test," the ground truth would be the expected or target speed, accuracy, and force output of the struts.
The sample size for the training set: Not applicable. The document refers to bench testing and substantial equivalence, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

January 6, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

OrthoSpin Ltd % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K202810

Trade/Device Name: AutoStrut G2 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: November 27, 2020 Received: November 27, 2020

Dear Janice Hogan:

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

{1}------------------------------------------------

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,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) K202810

Device Name

AutoStrut G2

Indications for Use (Describe)

AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:

fracture fixation (open and closed)
pseudoarthrosis of long bones
limb lengthening (epiphyseal or metaphyseal distraction)
joint arthrodesis
infected fractures or nonunions
correction of bony or soft tissue deformities ●
correction of segmental defects. ●

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

凶 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K202810 page 1 of 2 510(k) SUMMARY OrthoSpin's AutoStrut G2

OrthoSpin, Ltd.

13 Hayezira Street, Yokneam, Israel

Phone: +972.54.334.2651 Facsimile: +972.46886054

Contact Person: Oren Cohen

Date Prepared: January 5, 2021

Name of Device: AutoStrut G2

Common or Usual Name: External ring fixation system

Product Codes: KTT, OSN

Regulation Name: 21 CFR 888.3030 Single / multiple component metallic bone fixation appliances and accessories

Predicate Devices

K191241 AutoStrut, OrthoSpin Ltd.

Intended Use / Indications for Use

AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:

fracture fixation (open and closed)
pseudoarthrosis of long bones
. limb lengthening (epiphyseal or metaphyseal distraction)
joint arthrodesis
infected fractures or nonunions
. correction of bony or soft tissue deformities
correction of segmental defects.

{4}------------------------------------------------

Technological Characteristics

Performance Data

· Static compression, static torsion, static cantilever bending, and dynamic compression/tension testing per ASTM F1541

· Electrical safety testing per IEC 60601-1 and IEC 60601-1-11
· EMC testing per IEC 60601-1-2
Software characterization and validation
· Sterilization validation per ISO 17665-1, ISO 17665-2, ISO 11737-1 and ISO 11737-2
· Cytotoxicity testing per ISO 10993-5
Speed and accuracy evaluation
Reliability, force and accuracy test
Corrosion Test

Substantial Equivalence

AutoStrut G2 is substantially equivalent to OrthoSpin's AutoStrut (K191241). AutoStrut G2 has the exact same indications as the AutoStrut (K191241). Furthermore, it has the same principles of operation and similar technological characteristics as the previously cleared predicate AutoStrut. The primary differences between AutoStrut G2 and AutoStrut are: the motors are assembled separately from the telescopic rods, control box modifications, addition of short strut length to existing medium and long lengths, and software modification to enable more increments per day of rod expansion. In addition, the sterilization method was changed from EtO to steam sterilization by the end user.

These minor differences in the technological characteristics compared to the predicate do not raise different questions of safety or efficacy. Bench testing demonstrates that the AutoStrut G2 is as safe and effective as its predicate device.

Conclusions

The AutoStrut G2 is substantially equivalent to its predicate.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.