The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Device Description

The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.

AI/ML Overview

This document is a 510(k) summary for the Oyster ACIF Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical testing, rather than an AI/ML-driven device that would involve a test set, ground truth, and human reader performance studies.

Therefore, many of the requested criteria for an AI/ML device, such as acceptance criteria based on metrics like sensitivity/specificity, sample size for AI test sets, expert adjudication methods, MRMC studies, and training set information, are not applicable to this submission.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria in the traditional sense for an AI/ML device (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it focuses on mechanical performance data comparing the device's strength to predicate devices. The acceptance criteria are implicitly that the mechanical test results are "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Performance Test	Standard	Reported Performance	Acceptance Criteria (Implicit)
Static Axial Compression	ASTM F2077	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.
Static Compression Shear	ASTM F2077	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.
Static Torsion	ASTM F2077	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.
Dynamic Axial Compression	ASTM F2077	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.
Dynamic Compression Shear	ASTM F2077	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.
Dynamic Torsion	ASTM F2077	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.
Subsidence	ASTM F2267	Sufficient / Substantially Equivalent to Predicate	Mechanical strength suitable for intended use & comparable to legally marketed predicates.

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

This information is not applicable as the device is a spinal implant, not an AI/ML diagnostic tool. The "testing" refers to mechanical and material property tests on the device itself, not a clinical test set of patient 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)

This is not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels for medical data, typically established by clinical experts. For a spinal implant, "ground truth" relates to the physical and biological performance of the material and design, established through engineering standards and biological compatibility assessments.

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

This is not applicable. Adjudication methods are used in clinical studies involving interpretation of medical images or data by human experts for ground truth establishment.

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

This is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance in diagnostic tasks. This device is a physical implant.

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

This is not applicable. Standalone performance is a concept for AI algorithms.

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

For this device, the "ground truth" to which its performance is compared is based on established engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. It's a "truth" derived from physical and mechanical testing, not clinical diagnosis.

8. The sample size for the training set

This is not applicable. This refers to AI/ML model training, which is not relevant for this medical device.

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

This is not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant). The acceptance criteria and performance data discussed are related to the device's mechanical and material properties, rather than its performance as an AI/ML diagnostic tool. Therefore, many of the questions asked, which are specific to AI/ML device evaluation, are not relevant to this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

Silony Medical GmbH % Ms. Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918

Re: K182608

Trade/Device Name: Oyster ACIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 13, 2019 Received: May 14, 2019

Dear Ms. May:

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

June 13,2019

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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,

for Melissa Hall 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 SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement on last page.
510(k) Number (if known)
K182608
Device Name
Oyster ACIF Cage
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K182608 - 510(K) SUMMARY

Submitter's Name:	Katharina BarschSilony Medical GmbH
Submitter's Address:	Leinfelder Straße 60Leinfelden-Echterdingen, Germany D-70771
Submitter's Telephone:	+49 711 78 25 25 40
Additional Contact Person:	Meredith Lee May MS, RACEmpirical Consulting719.337.7579MMay@EmpiricalConsulting.com
Date Summary was Prepared:	18 Sep 2018
Trade or Proprietary Name:	Oyster ACIF Cage
Common or Usual Name:	Intervertebral Fusion Device with Bone Graft, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	ODP
Classification Panel:	Abdominal and Surgical Devices Branch (ASDB)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Oyster CIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster CIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster CIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

TECHNOLOGICAL CHARACTERISTICS

Oyster ACIF Cage is made from Ti6Al4V ELI (Grade 23). 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:

Materials of manufacture ●

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Structural support mechanism ●
Manufacturing methods ●

510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K162587	ROCCIA® ACIF	Silony Medical GmBH	Primary
K172888	EIT Cellular Titanium®Cervical Cage	EIT Emerging ImplantTechnologies GmbH	Additional

PERFORMANCE DATA

The Oyster ACIF Cage 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
Dynamic Axial Compression per ASTM F2077 ●
. Dynamic Compression Shear per ASTM F2077
Dynamic Torsion per ASTM F2077 .
Subsidence per ASTM F2267 .

The results of this non-clinical testing show that the strength of the Oyster ACIF Cage 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 Oyster ACIF Cage 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.