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The "BioGend" Interbody Fusion System 001 Cage 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. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment with an intervertebral cage. "BioGend" Interbody Fusion System 001 Cage is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine

"BioGend" Interbody Fusion System 001 Cage is designed to be inserted into the intervertebral body space of the spine as an adjunct to fusion. "BioGend"Interbody Fusion System 001 Cage consists of lumbar cages which are available in various heights and lengths to fit the patient's anatomical and physiological requirements. The superior and inferior surfaces of the "BioGend" cages have teeth to help prevent implant dislodgement or expulsion once placed in the desired location. The cages are made of polyetheretherketone (PEEK) which complies with ASTM F2026, and the radiographic markers incorporated into the cages are made of titanium alloy (Ti-6Al-4V ELI) conforming to ISO 5832-3 and ASTM F136. The cages are supplied sterile and intended for single use only. All implants should not be reused under any circumstances.

This document is a 510(k) summary for a medical device called the "BioGend" Interbody Fusion System 001 Cage. It is used for spinal fusion procedures. This summary focuses on non-clinical performance testing rather than AI/software performance. Therefore, most of the requested information regarding AI/software acceptance criteria and studies is not applicable or cannot be extracted from this document.

However, I can provide information relevant to the non-clinical acceptance criteria and the study that proves the device meets them, as described in the document.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily discusses non-clinical testing for equivalence to a predicate device.

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

   Test Performed	Acceptance Criteria (Stated)	Reported Device Performance
   Sterilization verification	Not explicitly detailed beyond "Sterilization verification" and "The cages are supplied sterile". Implies compliance with relevant standards to ensure sterility.	"All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific data not provided in this summary.)
   Shelf life	Not explicitly detailed beyond "Shelf life". Implies compliance with relevant standards to ensure the device remains safe and effective for its designated shelf life.	"All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific data not provided in this summary.)
   Biocompatibility	Not explicitly detailed beyond "Biocompatibility". Implies compliance with ISO 10993 series and other relevant standards to ensure the materials are safe for use in the human body.	"All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific data not provided in this summary.)
   Performance Testing	Compliance with:

• ASTM F2077-22 (Standard Test Methods for Intervertebral Body Fusion Devices)
• ASTM F2267-22 (Standard F2267, Standard Test Method for Measuring the Load Bearing Response of a Spinal Implant When Subjected to a Static Compressive Force. Note: The document states 2267-22, which is for compressive load, but the test listed is "static compression-shear test" which typically aligns with F2077-22, and F2267 is specifically for static compression.
• FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".

Specific tests mentioned include:

• Static and dynamic axial compression test
• Static compression-shear test
• Compressive Subsidence test
• Static and dynamic torsional test
• Expulsion test

Overall Acceptance: The subject device must meet the requirements of its pre-defined acceptance criteria and intended use, and be substantially equivalent to the predicate device. For dimensions, while similar, the device "meets the requirements," implying it is within acceptable ranges for function. | "All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific numerical data from the tests are not included in this summary, only the statement of compliance.) For dimensions, it is stated that even with slight differences, "The performance of the subject device is not affected and meets the requirements. Thus, it would not affect the equivalence." |

2. Sample sized used for the test set and the data provenance:

   • Sample Size: Not specified in this 510(k) summary. The summary refers to a "series of tests," but does not quantify the number of devices or observations per test.
   • Data Provenance: The tests are non-clinical, likely conducted in a controlled laboratory environment. The submitting company is BioGend Therapeutics Co., Ltd., located in Taipei, Taiwan. The document does not specify the country of origin of the raw data beyond the submitter's location. The data is retrospective in the sense that it was collected prior to submission for FDA review.

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 question is not applicable to this document. The "ground truth" here is established through mechanical and material testing standards (ASTM, ISO), rather than clinical expert interpretation or labeling of images. The device is a physical interbody fusion cage, not an AI or software device that interprets medical images.

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

   • This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for AI/software, to resolve discrepancies in expert interpretation of clinical data. This document describes non-clinical engineering/materials testing where results are quantitative and compared against established standards.

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 question is not applicable to this document. This device is a physical implant, not an AI-assisted diagnostic or treatment planning software. No clinical studies, MRMC or otherwise, were conducted or referenced for this 510(k) submission.

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

   • This question is not applicable to this document. This is not an algorithm or software device. Bench testing was done on the physical device itself.

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

   • The "ground truth" for the non-clinical testing is compliance with established international and FDA-recognized mechanical testing standards (e.g., ASTM F2077-22, ASTM F2267-22) and biomaterial standards (e.g., ASTM F2026 for PEEK, ISO 5832-3 and ASTM F136 for Ti-6Al-4V ELI). These standards define the performance requirements and test methods for such devices.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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 established for it.

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