The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.

Device Description

The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family including the PLIF Caliber Lordotic, the TLIF Bullet, and the TLIF Camber consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy. The Southern TLIF family implants are offered with straight or curved profiles. The straight profiles include the PLIF Caliber Lordotic (a PLIF) implanted from the posterior approach and the TLIF Bullet (a T-PLIF or straight TLIF) implanted from the transforaminal approach. The curved version is the TLIF Camber (a curved TLIF) implanted from the transforaminal approach.

The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Southern TLIF family implants are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The curved TLIF designs include a titanium alloy hinge (Ti-6Al-4V per ASTM F136). The Southern TLIF family implants are provided sterile.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided FDA 510(k) summary, structured to answer your questions.

It's important to note that this document is an FDA 510(k) Summary for a medical device (intervertebral body fusion device), not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions, particularly those related to AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this type of medical device submission. The performance testing for these devices primarily focuses on mechanical and biological characteristics, not diagnostic accuracy.

Description of the Acceptance Criteria and Performance Study for Southern Transforaminal Lumbar Interbody Fusion (TLIF)

This 510(k) submission describes the Southern Transforaminal Lumbar Interbody Fusion (TLIF) device family. The acceptance criteria and performance study for this type of device are centered on demonstrating mechanical strength, durability, and biocompatibility, as opposed to diagnostic accuracy or AI performance. The study aims to prove that the device is substantially equivalent to legally marketed predicate devices.

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

For interbody fusion devices, acceptance criteria are generally based on meeting or exceeding the mechanical performance and safety standards demonstrated by legally marketed predicate devices, as well as relevant ASTM standards. The reported performance indicates that the device met these criteria.

Acceptance Criteria Category	Specific Test Standard / Performance Goal	Reported Device Performance (Summary)
Mechanical Strength	Static and Dynamic Axial Compression (ASTM F2077)	Sufficient for intended use, substantially equivalent to predicates.
Mechanical Strength	Static and Dynamic Compression Shear (ASTM F2077)	Sufficient for intended use, substantially equivalent to predicates.
Durability	Subsidence (ASTM F2267)	Sufficient for intended use, substantially equivalent to predicates.
Biocompatibility	Materials used (PEEK per ASTM F2026, Tantalum per ASTM F560, Ti-6Al-4V per ASTM F136)	Manufactured from standard, biocompatible materials commonly used in spinal implants.
Sterility	(Not explicitly detailed, but implied for medical implants)	Device is provided sterile.

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 for Mechanical Testing: The specific number of devices tested for each mechanical test (axial compression, compression shear, subsidence) is not provided in this summary. It would typically follow the guidance within the respective ASTM standards (F2077, F2267).
Data Provenance: The mechanical testing (non-clinical testing) would typically be conducted in a laboratory setting. The summary refers to the manufacturer's location as South Africa, but does not specify the testing location. This is not patient-derived data; it's device performance data.

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. For this type of mechanical device (interbody fusion device), "ground truth" is established through engineering and material science principles, laboratory testing against established standards, and comparison to predicate devices, not through expert clinical consensus on patient data.

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

Not applicable. Adjudication methods are typically associated with clinical studies, especially those involving expert review of patient data (e.g., imaging). Mechanical testing results are objective measurements from laboratory experiments.

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 submission is for a physical implantable device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance is based on:

Engineering Standards: Adherence to ASTM standards (F2077 for static/dynamic compression and shear, F2267 for subsidence) which define acceptable mechanical properties for spinal implants.
Material Specifications: Use of materials (PEEK, Tantalum, Titanium Alloy) that meet established ASTM standards for biocompatibility and mechanical properties (e.g., ASTM F2026, F560, F136).
Predicate Device Performance: Benchmarking against the known, safe, and effective mechanical performance of legally marketed predicate interbody fusion devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As the device does not involve a training set, the establishment of ground truth for such a set is irrelevant.

Summary

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December 8, 2022

Southern Medical (Pty) Ltd % Nathan Wright Engineer and Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K221182

Trade/Device Name: Southern Transforaminal Lumbar Interbody Fusion (TLIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 11, 2022 Received: November 14, 2022

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.

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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 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.

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. 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

Indications for Use

510(k) Number (if known) K221182

Device Name

Southern Transforaminal Lumbar Interbody Fusion (TLIF)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) 図 Prescription Use (Part 21 CFR 801 Subpart D)

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

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K221182 - 510(K) SUMMARY

Submitter's Name:	Southern Medical (Pty) Ltd
Submitter's Address:	55 Regency DriveRoute 21 Corporate ParkIrene, Centurion, Gauteng 0178South Africa
Submitter's Telephone:	+27 12 667 6243/4
Contact Person:	Nathan Wright MSEmpirical Technologies1-719-351-0248nwright@empiricaltech.comImage: Empirical Technologies Logo
Date Summary was Prepared:	November 10, 2022
Trade or Proprietary Name:	Southern Transforaminal Lumbar Interbody Fusion (TLIF)
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic Devices - Spinal Devices (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS

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 the same between the subject and predicates:

Indications for Use
Materials of manufacture
Structural support mechanism
Sizes

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	ProductCode	PredicateType
K150061	LUCENT®, LUCENT Ti-BOND®	Spinal Elements, Inc.	MAX	Primary
K171657,K092193	ShurFit 2C Lumbar Interbody Fusion(originally Spinal USA Intervertebral BodyFusion Device)	Precision Spine, Inc.(formerly Spinal USA)	MAX	Additional
K172341	NuVasive® Modulus TLIF InterbodySystem	NuVasive, Inc.	MAX,PHM	Additional
K113561	TM Ardis® Interbody System	Zimmer TrabecularMetal Technology, Inc.	MAX	Additional
K133614	Aleutian IBF System (Lumbar)	K2M, Inc.	MAX	Additional

PERFORMANCE DATA

The Southern TLIF family (PLIF Caliber Lordotic and TLIF Bullet) has been tested in the following test modes:

Static and Dynamic Axial Compression per ASTM F2077 ●
Static and Dynamic Compression Shear per ASTM F2077
. Subsidence per ASTM F2267

The results of this non-clinical testing show that the strength of the Southern TLIF 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 Southern TLIF family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.