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The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The Milestone Spinal System consists of INVIBIO PEEK-OPTIMA LT1 lumbar cages of various lengths and heights, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The cages are provided sterile. The Milestone Spinal System also includes various device specific instruments which are provided non-sterile.

Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program. The summary explicitly states:

"Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:" (followed by a list of standards).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for non-clinical tests (e.g., how many devices were tested for seal strength or ASTM F2077-03). Non-clinical tests typically refer to laboratory testing of physical and mechanical properties, not patient data. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" is not applicable here as no patient data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there was no clinical study or patient data involved in establishing ground truth. The "ground truth" for the non-clinical tests was established by adherence to recognized international and national standards (e.g., ISO, USP, ASTM) and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical study or patient data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is an intervertebral body fusion device (an implant), not a software algorithm or AI-based diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets the acceptance criteria (and is substantially equivalent) relies on physical and mechanical performance data obtained from non-clinical testing against recognized industry standards (e.g., ASTM F2077-03) and direct comparison of specifications (materials, dimensions, intended use) to an existing predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

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