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The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Velofix™ SA Cervical Cage consists of spacers, screws, locking plate and set screw. The spacers are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the spacers. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate. The Velofix™ SA Cervical Cage has three types: 1) All PEEK Type, 2) Ti plate Type, 3) Ti plate-N type. The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.

The provided text is a 510(k) premarket notification letter and summary for the Velofix™ SA Cervical Cage. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical performance testing.

However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of software or AI performance. The entire document focuses on the mechanical and material properties of an intervertebral fusion device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance (for software/AI).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth for software.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is for a medical device (an implantable cage), not a software or AI product. The "performance testing" mentioned refers to mechanical strength evaluation of the physical implant, not algorithmic performance.

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The Velofix™ PEEK Cervical Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Velofix™ PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease(DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

The Velofix™ Interbody Fusion System(K132926) consists of implants available in various heights, width and angle with an open architecture to accept packing of autogenous bone graft and consist of:

• 1. Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device (Velofix™ PEEK Lumbar Cage), which may be implanted.
  • Bilaterally via a posterior(PLIF) approach; o
  • o As a single device via a transforaminal(TLIF) approach;

The Velofix™ Interbody Fusion System(Pending:K140864) contains additional sizes in PEEK Lumbar cages of The Velofix™ Interbody Fusion System(Cleared: K132926).

The implants are made of radiolucent polymer polyether-ether-ketone(PEEK-OPTIMA LT 1, ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560). The Velofix " PEEK Lumbar Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Velofix™ Interbody Fusion System, framed within your requested categories.

Important Note: The provided document is a 510(k) summary for a medical device (surgical implant), not an AI/software device. Therefore, many of your requested categories (like multi-reader multi-case studies, ground truth establishment for AI, training sets, etc.) are not applicable to this type of submission. I will address only the information that can be extracted from the provided text for a non-AI medical device.

Acceptance Criteria and Study for Velofix™ Interbody Fusion System

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression Strength (ASTM F2077)
• Dynamic Compression Strength (ASTM F2077) | Met all acceptance criteria. |
  | Material Composition | Radiolucent PEEK-OPTIMA LT 1 (ASTM F2026) body with tantalum markers (ASTM F560) | Confirmed: PEEK-OPTIMA LT 1 (ASTM F2026) body with tantalum markers (ASTM F560). |
  | Design Features | Similar design features to predicate devices (K132926, K122872, K082342) | Confirmed: Similar design features. |
  | Intended Use | Similar indications for use as predicate devices | Confirmed: Similar indications for use. |
  | Fundamental Scientific Technology | Similar basic fundamental scientific technology as predicate devices | Confirmed: Similar basic fundamental scientific technology. |

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

• Sample Size: Not explicitly stated as a number of devices or iterations. The testing refers to "The additional size of Velofix™ Interbody Fusion System," implying the specific new sizes being introduced were tested.
• Data Provenance: The testing was a "non clinical setting (bench testing)." This indicates in-vitro laboratory testing, not human or animal data.
• Retrospective/Prospective: Not applicable, as this was bench testing.

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

• Not applicable. This section is for AI/software devices relying on expert interpretation of data. For mechanical devices, performance is assessed via standardized engineering tests, not expert consensus on "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. This applies to clinical interpretation or AI output review. Mechanical bench testing results are objective measurements against defined 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

• Not applicable. This refers to studies involving human readers and AI for diagnostic or interpretative tasks. This device is a surgical implant undergoing mechanical performance testing.

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

• Not applicable. This category refers to AI algorithm performance.

7. The Type of Ground Truth Used

• Engineering Standards: The "ground truth" for this device's performance is established by recognized engineering and material standards, specifically ASTM F2077 for static and dynamic compression, and ASTM F2026 and F560 for material specifications. The acceptance criteria were based on the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This section refers to AI model training. The "training" for this device involved adhering to established engineering principles and manufacturing processes.

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

• Not applicable. This refers to AI model training.

Summary of the Study:

The study described is a non-clinical bench testing assessment of the mechanical performance of the Velofix™ Interbody Fusion System, specifically focusing on additional sizes being introduced. The goal was to demonstrate substantial equivalence to previously cleared predicate devices (Velofix™ Interbody Fusion System K132926, Galaxy PLIF PEEK Cage K122872, and Capstone Spinal System K082342).

The testing included:

• Static compression test according to ASTM F2077
• Dynamic compression test according to ASTM F2077

The "acceptance criteria" were established by the performance of the predicate devices in these tests. The new device sizes met all acceptance criteria, thereby verifying that its performance is substantially equivalent to the predicate devices. The materials used (PEEK-OPTIMA LT 1 with tantalum markers) also conform to specified ASTM standards.

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