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The Longbow Ti Expandable Lateral Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Longbow Ti Expandable Lateral Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. The implant is hollow to permit packing with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Longbow Ti Expandable Lateral Spacer System components with components from any other system or manufacturer. The Longbow Ti Expandable Lateral Spacer System components should never be reused under any circumstances.

This 510(k) premarket notification is for the LongBow Ti Expandable Lateral Spacer System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information about clinical performance studies is not present.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria for clinical performance that an AI device would typically have (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to existing predicate devices through mechanical testing and comparison of design, materials, and indications for use.

• Conclusion: Presented to demonstrate equivalent mechanical performance to the Life Spine LongBow (K133717). The specific results or numerical acceptance criteria for these tests are not provided in this summary, but the claim is that they demonstrate equivalence. |
  | Material Equivalence | - Material: Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
• Conclusion: This is the same material used in the predicate devices (Life Spine LongBow K133717 and Life Spine TiBow K170919). |
  | Design Equivalence | - Conclusion: Shown to be substantially equivalent to the predicate systems in terms of design (e.g., expandable mechanism, hollow for bone graft, superior/inferior teeth). |
  | Indications for Use | - Conclusion: The Indications for Use are identical to the predicate devices. |
  | Function Equivalence | - Conclusion: Shown to be substantially equivalent to the predicate systems in terms of function (e.g., intervertebral body fusion device, allows for in-situ expansion). |
  | Sizing Equivalence | - Conclusion: Shown to be substantially equivalent to the predicate systems in terms of sizing (available in a range of sizes and footprints to suit individual pathology). |

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

This submission does not involve a clinical test set in the way an AI/software device would. The "testing" referred to is mechanical performance testing on the device itself. Therefore, a sample size for a clinical test set and its provenance are not applicable or provided.

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 this is a physical medical device (intervertebral body fusion device) and the "testing" is mechanical. Ground truth from experts is not established for a clinical test set in this context.

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

Not applicable for the same reasons as above.

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-assisted diagnostic device.

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

Not applicable. This is not an algorithm or AI device.

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

For mechanical testing, the "ground truth" would be established by the physical testing equipment and adherence to ASTM standards (ASTM F2077 & F2267). For the comparative claims, the ground truth is the established properties and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. Its acceptance criteria and proof focuses on demonstrating substantial equivalence to already cleared predicate devices through mechanical testing and comparison of design, materials, and intended use, rather than clinical performance against specific metrics like accuracy, sensitivity, or specificity that would be typical for an AI/software as a medical device (SaMD).

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