The SQUALE devices are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SQUALE devices are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The SQUALE devices are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Device Description

The SQUALE device consists of Polyetherketoneketone (PEKK) (compliant with ASTM F2820 standard) cervical cages of various widths and heights, which can be inserted between two cervical or cervico-thoracic vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be filled with autogenous and/or allogenic bone graft.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called SQUALE. It determines that the SQUALE device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in the context of your request for acceptance criteria and study details:

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

The provided FDA document does not explicitly state numerical acceptance criteria in a table format, nor does it present detailed numerical performance metrics for the SQUALE device against such criteria. Instead, it makes a general statement:

Acceptance Criteria (Implied)	Reported Device Performance
Meet ASTM F2077 standards	Performance testing conducted per ASTM F2077.
Meet ASTM F2267 standards	Performance testing conducted per ASTM F2267.
Substantially equivalent to predicate devices for static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsional, subsidence, and expulsion testing.	The results of these studies were determined to be substantially equivalent to legally marketed devices.
As safe and effective as the primary predicate device (Stryker's AVS AS PEEK Spacer).	The SQUALE is as safe and effective as the primary predicate device. Performance data demonstrate that the SQUALE is as safe and effective as the predicate device.
Raise no new issues of safety or effectiveness associated with technological differences.	The minor technological differences between the SQUALE and its predicate device raise no new issues of safety or effectiveness.

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 mentions "Performance testing was conducted per ASTM F2077 and ASTM F2267." These are standards for mechanical testing of intervertebral body fusion devices. These tests typically involve a specific number of devices to be tested to demonstrate compliance. However, the exact sample size (number of SQUALE devices tested) is not specified in this document.

The data provenance (country of origin, retrospective or prospective) is also not specified. Given it's bench testing, the concept of "country of origin of the data" might refer to where the testing was performed, which is not stated. These are typically prospective tests performed on newly manufactured devices.

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 information is not applicable as the SQUALE device is an implantable medical device, and the "ground truth" for its performance is established through mechanical bench testing against industry standards (ASTM F2077, ASTM F2267) and comparison to predicate devices, rather than through expert interpretation of clinical data. Therefore, there are no "experts" in the context of establishing ground truth for a test set based on human interpretation.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data, and there's a need to resolve disagreements. For mechanical performance testing of an implantable device, the results are typically quantitative and objective; they either meet the standard or they don't. There's no human interpretation or adjudication process in the sense of a clinical trial.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any indication that SQUALE is an AI-assisted device. The SQUALE is a physical intervertebral body fusion device.

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

This question is not applicable as SQUALE is not an algorithm or an AI-powered device. It is a physical implant.

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

For the SQUALE device, the "ground truth" for its performance is based on established engineering and biomechanical standards (ASTM F2077 and ASTM F2267). Compliance with these standards, along with demonstrating "substantial equivalence" to predicate devices through various mechanical tests, serves as the basis for its safety and effectiveness claims for regulatory purposes. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's functional performance in this document.

8. The sample size for the training set

This information is not applicable. The SQUALE device is not an AI/ML algorithm that requires a training set. It is a physical medical device.

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

This question is not applicable as there is no training set for a physical device like SQUALE.

Summary

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March 28, 2023

Implanet, S.A. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K230026

Trade/Device Name: SQUALE Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 9, 2023 Received: March 9, 2023

Dear Kelliann Payne:

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230026

Device Name

SQUALE

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K230026 510(k) SUMMARY Implanet, S.A.'s SQUALE

Implanet. S.A. Technopole Bordeaux Montesquieu Allée François Magendie 33650 Martillac Phone: + 33 557 995 555

Contact Person: Régis Le Couëdic

Date Prepared: March 12, 2023

Name of Device: SQUALE

Common or Usual Name: Cervical Intervertebral Body Fusion Device

Regulatory Class: 21 CFR 888.3080

Product Code: ODP

Predicate Devices

Primary Predicate: Stryker's AVS AS PEEK Spacer (K142251) ●
Additional Predicate: SpineUp, Inc Romero Cervical Cage (K212358)
Additional Predicate: RTI Surgical, Fortilink™-C with TETRAfuse™ 3D Technology ● (K163673)

Intended Use / Indications for Use

Technological Characteristics

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Performance Data

Performance testing was conducted per ASTM F2077 and ASTM F2267. Specifically, Implanet performed static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic torsional testing, subsidence testing, and expulsion testing. The results of these studies were determined to be substantially equivalent to legally marketed devices.

Substantial Equivalence

The SQUALE is as safe and effective as the primary predicate device, Stryker AS AVS PEEK spacer. The SQUALE has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the SQUALE and its predicate device raise no new issues of safety or effectiveness and are covered by the proposed secondary predicate device. Performance data demonstrate that the SQUALE is as safe and effective as the predicate device. Thus, the SQUALE is substantially equivalent.

Conclusions

The SQUALE is intended to treat degenerative disc disease, and bench testing demonstrates that it is as safe, as effective, and performs as well as the primary 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.