SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.

Device Description

The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "SPICCA Cervical Fusion Cages," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to diagnostic performance or efficacy for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI-powered device is not applicable to this submission.

However, I can extract information related to the device's physical performance testing as described:

Report on SPICCA Cervical Fusion Cages Performance (K230607)

The SPICCA Cervical Fusion Cages are intervertebral spinal fusion systems intended for cervical spine procedures. The device's performance was evaluated through non-clinical mechanical testing to demonstrate its safety and substantial equivalence to predicate devices. The document does not specify quantitative acceptance criteria or reported values for these tests, only that the device's strength was found sufficient and substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or reported values for the mechanical tests. It only states that the device's strength was "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices."

Test Mode	Acceptance Criteria (Not Specified Numerically)	Reported Device Performance (Not Specified Numerically)
Static axial compression	Sufficient strength for intended use and substantial equivalence to predicate devices.	Strength confirmed sufficient for intended use and substantially equivalent to predicate devices.
Static compression shear	Sufficient strength for intended use and substantial equivalence to predicate devices.	Strength confirmed sufficient for intended use and substantially equivalent to predicate devices.
Static torsion	Sufficient strength for intended use and substantial equivalence to predicate devices.	Strength confirmed sufficient for intended use and substantially equivalent to predicate devices.
Subsidence	Sufficient resistance to subsidence for intended use and substantial equivalence to predicate devices.	Resistance to subsidence confirmed sufficient for intended use and substantially equivalent to predicate devices.
Dynamic axial compression	Sufficient strength for intended use and substantial equivalence to predicate devices.	Strength confirmed sufficient for intended use and substantially equivalent to predicate devices.
Dynamic compression shear	Sufficient strength for intended use and substantial equivalence to predicate devices.	Strength confirmed sufficient for intended use and substantially equivalent to predicate devices.
Dynamic torsion	Sufficient strength for intended use and substantial equivalence to predicate devices.	Strength confirmed sufficient for intended use and substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for the mechanical tests. Mechanical testing typically involves a set number of samples for each test mode (e.g., 3-6 samples per test).
Data Provenance: The data is from non-clinical laboratory testing performed by the manufacturer or a certified testing facility, as part of the 510(k) submission process. It is not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a non-clinical mechanical performance study of a physical device, not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics measured during the tests.

4. Adjudication method for the test set

Not Applicable. As a non-clinical mechanical study, there is no expert adjudication method like those used for clinical assessments or AI model evaluations. The results are based on objective physical measurements against established ASTM standards and benchmarks (predicate devices).

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 is a physical medical device, not an AI diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

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

Not Applicable. This is a physical medical device. There is no algorithm for standalone performance testing in the context of diagnostic or assistive AI.

7. The type of ground truth used

For mechanical tests, the "ground truth" is typically defined by the physical test parameters, load applications, displacement measurements, and ultimate failure points, compared against specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance of an equivalently intended predicate device.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of AI/ML model development.

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

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth establishment method for it.

Summary

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August 14, 2023

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

Re: K230607

Trade/Device Name: SPICCA Cervical Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 19, 2023 Received: July 19, 2023

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 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.

Brent Showalter -S

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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Indications for Use

510(k) Number (if known) K230607

Device Name SPICCA Cervical Fusion Cages

Indications for Use (Describe)

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)

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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.com
Date Summary was Prepared:	March 3, 2023
Trade or Proprietary Name:	SPICCA Cervical Fusion Cages
Common or Usual Name:	Interbody Fusion Device, Cervical
Classification:	Class II per 21 CFR §888.8030
Product Code:	ODP
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 identical between the subject and predicates:

Indications for Use
Materials of manufacture
Structural support mechanism ●

Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	ProductCode	PredicateType
K210044	Crystal Spinal System	Spinal Elements, Inc.	ODP	Primary
K200458	Tailored-C Cervical Interbody Fusion System	BeSpoke Technologies	ODP	Additional
K172320	Neurostructures Cavetto® Cervical Cage System	NeuroStructures, Inc.	ODP	Additional
K193369	SureMAX™ Family of Cervical Spacers	Additive Implants, Inc.	ODP	Additional

PERFORMANCE DATA:

The SPICCA Cervical Fusion Cages has been tested in the following test modes:

Static axial compression per ASTM F2077
Static compression shear per ASTM F2077 ●
Static torsion per ASTM F2077 ●
Subsidence per ASTM F2267 ●
Dynamic axial compression per ASTM F2077
Dynamic compression shear per ASTM F2077 ●
. Dynamic torsion per ASTM F2077

The results of this non-clinical testing show that the strength of the SPICCA Cervical Fusion Cages 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 SPICCA Cervical Fusion Cages are 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.