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The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively.

This document is a 510(k) premarket notification for a medical device called the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device is an interbody fusion device and the submission is focused on demonstrating its similarity to a previously cleared version of the same product. There is no study provided that establishes specific acceptance criteria or measures the performance of the device against such criteria. Instead, the submission relies on the concept of substantial equivalence.

Here's an analysis based on your requested information points:

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

The provided FDA letter and 510(k) summary do not contain specific acceptance criteria or performance metrics for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The submission is based on demonstrating that the modified device has identical uses, indications, technological characteristics, and principles of operation as the predicate device (K181531).

Therefore, a table like the one requested cannot be created from the given text. The "reported device performance" is essentially that it is considered "substantially equivalent" to the predicate, implying it performs equivalently.

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

There is no test set described for performance evaluation in the provided document. The submission explicitly states: "Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required." This indicates that the regulatory clearance is based on the equivalence of the device's design and materials, not a new performance study.

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, as no test set or ground truth establishment study is described for the device's performance.

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

Not applicable, as no test set or adjudication process is described.

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 device is a physical implant (interbody fusion device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness analysis is irrelevant to this submission.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

Not applicable, as no specific performance study requiring ground truth is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as this is a physical medical device and does not involve a training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which relies on demonstrating substantial equivalence to a previously cleared predicate device.

• Acceptance Criteria for Substantial Equivalence: The acceptance criteria are implicitly that the modified device should have:

  • Identical indications for use.
  • Identical materials of manufacture.
  • Identical structural support mechanism.
  • Identical principles of operation.
  • No new types of safety or effectiveness questions compared to the predicate.

• Proof of Meeting Acceptance Criteria: The document explicitly states:

  "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness when compared to the predicate. Specifically, the following characteristics are identical between the subject and predicates: Indications for use, Materials of manufacture, Structural support mechanism, Principles of operation."

  "Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required. However, risk analysis was conducted on the additional instruments."

  "The modified SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are very similar to previously cleared SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The subject has identical uses, indications, technological characteristics, and principles of operation as the predicate device. The modifications raise no new types of safety or effectiveness questions when compared with the predicate device. The overall technological characteristics lead to the conclusion that SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are substantially equivalent to the predicate device."

In essence, the "study" is a comparative analysis of the device's design, materials, and intended use against a cleared predicate device (K181531) to assert that the modifications do not introduce new safety or effectiveness concerns and that the device remains substantially equivalent. No experimental performance data on the device itself is presented in this document.

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