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The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Duo Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.

The provided text is a 510(k) summary for a medical device called the Duo™ Lumbar Interbody Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics typically associated with AI/ML devices or novel diagnostic tools.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. This document describes a modification to an existing device, not a performance study comparing a device's output to a ground truth with specific acceptance criteria.

Here's an breakdown of why most sections cannot be filled, and what information is available:

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

• Not Applicable. This document does not establish performance acceptance criteria in the way a diagnostic or AI device would (e.g., sensitivity, specificity, accuracy). Its purpose is to demonstrate that modifications to an already-cleared device do not alter its safety or effectiveness compared to its predicate. The "performance" being assessed is a comparison to the predicate device, not against absolute clinical metrics.

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

• Not Applicable. There is no "test set" in the context of clinical data for this type of submission. The document refers to "verification testing" for surgical instrumentation and "review of design changes" and "risk assessment" for the implant, but these are engineering and design control activities, not clinical studies with patients.

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. No ground truth established by experts for a test set is mentioned.

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

• Not Applicable. No test set or related 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 is not an AI/ML device, and no MRMC study is mentioned.

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 concensus, pathology, outcomes data, etc)

• Not Applicable. No ground truth in the clinical sense is discussed. The "ground truth" relevant to this submission is the expectation that the modified device remains functionally and safely equivalent to the predicate, based on engineering analysis and non-clinical testing.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no training set.

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

• Not Applicable. No training set or ground truth for it.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "acceptance criteria and study" format for an AI/diagnostic device, here's what can be extracted relevant to the device's assessment:

Device Details:

• Device Name: Duo™ Lumbar Interbody Fusion Device
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Predicate Device: K160074 Rampart™ D Lumbar Interbody Fusion Device (Spineology Inc.)

Purpose of Submission:

To obtain FDA clearance for modifications to the Duo Lumbar Interbody Fusion Device, including:
* Name change
* Updated surgical instrumentation
* Updated product labeling (no change to indications or contraindications)
* Minor modifications to the Duo implant
* Shelf life extension

Confirmation of Equivalence (rather than "performance against acceptance criteria"):

The core of this submission is to demonstrate substantial equivalence to the predicate device. The following points confirm that the device meets the criteria for substantial equivalence, rather than providing numerical performance metrics:

• Duo Implantable Devices:
  • A review confirmed modifications do not alter the primary device design, introduce new technological characteristics, or alter the intended use.
  • A risk assessment confirmed modifications do not alter the risk profile or present new issues of safety or effectiveness.
• Duo Surgical Instrumentation:
  • Verification testing was performed to support modifications.
  • A review confirmed modifications do not present new technological characteristics or alter the intended use of these devices.
  • For instruments interfacing with the implant, the implant/instrument interface remained unchanged.
  • Design changes aimed to improve ergonomics and usability but do not alter the primary control mechanism or operating principle.
  • A risk assessment confirmed modifications do not alter the risk profile or present new issues of safety or effectiveness.

Comparison to Predicate (Criteria for Substantial Equivalence):

When compared to the predicate device, the modified Duo System has the same or equivalent:

• Intended Use
• Indications for Use
• Fundamental Scientific Technology
• Principle of Operation
• Device Design
• Materials of Construction
• Risk Profile

Conclusion:

Based on the review of modifications, Spineology has demonstrated that the modified Duo System is substantially equivalent to the predicate device.

In essence, this document is an administrative and engineering review to ensure that minor changes to an already-cleared device do not negatively impact its safety or effectiveness, thus maintaining its "acceptance" based on the predicate device's prior clearance.

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