ACURA Stabilization System is intended to help provide immobilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
Degenerative spondylolisthesis
Trauma (fracture or dislocation)
Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
Spinal tumours
Spinal Stenosis
Pseudarthrosis
Previous Failed Fusions
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The ACURA Stabilization System is a single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks). The hooks are available in different types based on the attachment points on the vertebra such as the Lamina and Transverse Process. The screws are available in multiple diameters and lengths based on variations in the spinal anatomy. Variants in screws are also available based on the surgical procedure requirement such as polyaxial screws, monoaxial screws, uniplanar screws, cannulated screws, fenestrated screws, long tab screws, dual outer diameter screws. Locking caps are available which lock the screw head onto the rods. These devices can be rigidly locked into a variety of configurations as per surgical conditions and are available in a variety of sizes to accommodate individual patient anatomy.
Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use.
The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537).
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

AI/ML Overview

The provided text is a 510(k) summary for the ACURA Stabilization System, a medical device used for spinal stabilization. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria for the mechanical tests. Instead, it states that "The results of this non-clinical testing show that the strength of the ACURA Stabilization System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the performance of the ACURA Stabilization System met or exceeded the performance of the predicate devices.

Acceptance Criteria	Reported Device Performance
Mechanical strength sufficient for intended use and substantially equivalent to legally marketed predicate devices.	The ACURA Stabilization System's static compression bending, static torsion, dynamic compression bending, axial grip, and torsional grip testing results demonstrate its strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

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

The document does not specify the sample size used for the mechanical testing (e.g., number of constructs tested). It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

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)

This question is not applicable to this type of device. The ACURA Stabilization System is a mechanical implant, and its performance is evaluated through engineering mechanical tests, not through expert-reviewed clinical data or ground truth labeling in the context of diagnostic AI.

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

Not applicable. As noted above, this device relies on mechanical testing, not human-reviewed data with adjudication.

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. The ACURA Stabilization System is a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable.

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

The "ground truth" for this device's performance is established through standardized material and mechanical testing specifications (e.g., ASTM F136, ASTM F1537, ASTM F1717-18, ASTM F1798). The performance is compared against the known performance of legally marketed predicate devices in these tests.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

Summary

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October 26, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

Indius Medical Technologies Pvt. Ltd. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K200937

Trade/Device Name: ACURA Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 25, 2020 Received: September 29, 2020

Dear Nathan Wright:

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

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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 (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 medical devices and radiation-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 O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

Indications for Use

510(k) Number (if known) K200937

Device Name

ACURA Stabilization System

Indications for Use (Describe)

Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

1. Degenerative spondylolisthesis
1. Trauma (fracture or dislocation)
1. Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
న్. Spinal tumours
1. Spinal Stenosis
1. Pseudarthrosis
Previous Failed Fusions 8.

When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

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

∑ 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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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5.510(K) SUMMARY

Submitter's Name:	Indius Medical Technologies Pvt. Ltd.
Submitter's Address:	Unit No. 12, Electronic Co-Operative Estate, Pune-Satara
	Road Pune – 411009, MH, India
Submitter's Telephone:	+91 20 29701607
Contact Person:	Nathan Wright MS
	Empirical Testing Corp.
	719-351-0248
	nwright@empiricaltech.com
Date Summary was Prepared:	April 9, 2020
Trade or Proprietary Name:	ACURA Stabilization System
Common or Usual Name:	Thoracolumbosacral Pedicle Screw System
Classification:	Class II per 21 CFR §888.3070 and 21 CFR §888.3050
Product Code:	NKB, KWQ, KWP
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use.

The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537).

The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

INDICATIONS FOR USE

ACURA Stabilization System is intended to help provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as

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an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
1. Degenerative spondylolisthesis
1. Trauma (fracture or dislocation)
1. Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
1. Spinal tumours
1. Spinal Stenosis
1. Pseudarthrosis
1. Previous Failed Fusions

When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

TECHNOLOGICAL CHARACTERISTICS

The ACURA Stabilization System is made from titanium alloy per ASTM F136 or cobalt chrome alloy per ASTM F1537. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use
Technological Characteristics
Component Styles ●
Materials ●
Sizes
Manufacturing & Biocompatibility

510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K142381	Xia® 3 Spinal System	Stryker Spine	Primary
K110280	REVLOK™ FenestratedScrew System	Globus Medical Inc.	Additional
K193365	M.U.S.T. Pedicle ScrewSystem	Medacta International SA	Additional

Table 5-1 Predicate Devices

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K180458	FOCUS Pedicle ScrewSystem	Nvision BiomedicalTechnologies, LLC	Additional
K131802	EXPEDIUM® Spine System	DePuy Spine, Inc.	Additional
K180210	CREO® StabilizationSystem	Globus Medical Inc.	Additional
K133350	REVERE® StabilizationSystem	Globus Medical Inc.	Additional

PERFORMANCE DATA

The ACURA Stabilization System has been tested in the following test modes:

Static compression bending per modified ASTM F1717-18 ●
Static torsion per ASTM F1717-18 .
Dynamic compression bending per ASTM F1717-18 ●
Axial grip testing per ASTM F1798 ●
. Torsional grip testing per ASTM F1798

The results of this non-clinical testing show that the strength of the ACURA Stabilization System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the ACURA Stabilization System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.