The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Perior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.

The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-PT Intervertebral body fusion system

The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The Peridot-PT Cages are a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).

Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles.

The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).

The Peridot-PT Cages are made from Ti-6AI-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of Cancellous and/or corticocancellous bone graft. The hyperlordotic lumbar cages (>20 decree) the form of supplemental fixation should be an anterior plate system.

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

AI/ML Overview

The provided document is a 510(k) premarket notification for "Peridot-PT Anterior Cervical Intervertebral body fusion System" and "Peridot-PT Intervertebral body fusion system." This document focuses on demonstrating substantial equivalence to previously cleared devices, primarily through technological comparison and mechanical performance testing, rather than clinical efficacy studies often associated with AI/software devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to clinical performance, human expert analysis, and multi-reader studies) are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" as one might see for clinical accuracy metrics. Instead, the performance testing focuses on mechanical characteristics, and the implicit acceptance criterion is that the device performs comparably to the predicate device and meets established ASTM standards.

Acceptance Criteria (Implicit from testing)	Reported Device Performance
Mechanical integrity under various loads according to ASTM F2077	Device tested in static compression, static compression-shear, static torsion, fatigue compression, fatigue compression-shear, fatigue torsion
Resistance to subsidence according to ASTM F2267	Device tested in subsidence test
Material conformity to ASTM F3001 (Ti-6AI-4V ELI)	Device stated to be made from Ti-6AI-4V ELI conforming to ASTM F3001
Sterilization efficacy (ISO 11137 or ISO 17665)	Devices are to be sterilized by gamma radiation per ISO 11137 or steam sterilization per ISO 17665

2. Sample size 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 a "sample size" in the context of clinical data or patient studies. The testing described is mechanical (benchtop) in nature. The data provenance is implicit; the tests were conducted as part of the submission process, likely by the manufacturer or a contract testing lab. There is no information regarding country of origin for mechanical testing 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. This submission concerns a physical implantable device, not a diagnostic or AI-powered software device requiring expert-established ground truth from medical images or clinical outcomes.

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

Not applicable. There is no mention of adjudication for clinical or image-based data.

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 not an AI/software device, and no MRMC study was performed.

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

Not applicable. This is not an algorithmic or software device.

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

For the mechanical testing, the "ground truth" would be the established ASTM standards and the expected performance of the predicate devices. The device's performance is compared against these engineering standards and the known characteristics of equivalent devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

Summary

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November 21, 2023

GBS Commonwealth Co., Ltd. Jimmy Kim RA C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 South Korea

Re: K233084

Trade/Device Name: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: September 25, 2023 Received: September 26, 2023

Dear Jimmy Kim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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Indications for Use

510(k) Number (if known)

K233084

Device Name

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system

Indications for Use (Describe)

Peridot-PT Anterior Cervical Intervertebral body fusion System

Peridot-PT Intervertebral body fusion system

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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SUMMARY

The following summary is being submitted as required by 21 CFR 807.92(a):

1. Device Identification

Submitter:	GBS Commonwealth Co., Ltd.#C-309, 168 Gasan Digital 1-ro, Geumcheon-Gu Seoul,South KoreaPhone. 82-2-6925-4469e-mail: Jimmy.kim@gbscommonwealth.com
Contact Person:	Jimmy Kim
Date prepared	September, 25, 2023

Trade Name	Peridot-PT Anterior Cervical Intervertebral bodyfusion System, Peridot-PT Intervertebral bodyfusion system
Regulatory Class	Class II
Classification Name	Intervertebral body fusion device(21 CFR 888.3080)
Panel	Orthopedic
Product Code	ODP, MAX

2. Purpose of 510(k)

The GBS Commonwealth Co. Ltd., here by submits this submission: for Initial product Introduction of Peridot-PT Anterior Cervical Intervertebral body fusion system and Peridot-PT Intervertebral body fusion system

3. Predicate or legally marketed devices which are substantially equivalent

Primary Predicate Device : K213755 Peridot-PT Anterior Cervical Intervertebral body

fusion System, Peridot-PT Intervertebral body fusion system

Additional Predicate Device : K201605 EIT Cellular Titanium Cervical Cage,

EIT Cellular Titanium ALIF,TLIF,LLIF,T/PLIF Cage

Page 1 of 4

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4. Description of the Device

The devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.

5. Indication for Use

Peridot-PT Anterior Cervical Intervertebral body fusion System

The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

These patients should have had at least six weeks of nonoperative treatment.

The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use Page 2 of 4

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with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Peridot-PT Intervertebral body fusion system

Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Comparison of the technological characteristics of the subject and predicate 6. devices

Peridot-PT Anterior Cervical Intervertebral body fusion system and Peridot-PT Intervertebral body fusion system are considered substantially equivalent to the primary predicate GBS Peridot-PT ALIF, TLIF, LLIF T/PLIF Cage K213755 and additional predicate devices. They are similar in design, material, scientific technologies and indications for use.

7. Performance Testing

The worst-case devices were tested in static compression, static compression-shear, static torsion, fatique compression, fatique compression-shear, fatique torsion (ASTM F2077) and subsidence test (ASTM F2267).

8. Conclusion

Based on the information provided in this premarket notification of GBS Commonwealth Co., Ltd. concludes that Peridot-PT Anterior Cervical Intervertebral body fusion system and Peridot-PT Intervertebral body fusion

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system are substantially equivalent to predicate devices.

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.