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The VelofixTM 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 with an intervertebral cage.

The VelofixTM 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.
  • o Bilaterally via a posterior(PLIF) approach;
  • o As a single device via a transforaminal(TLIF) approach;

The Velofix™ Interbody Fusion System contains additional surface and angle in PEEK Cervical cages of the Velofix™ Interbody Fusion System (Cleared: K132926, K140864).

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 Cervical Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

The provided document is a 510(k) summary for the Velofix™ Interbody Fusion System, which is a medical device for spinal fusion. This specific submission (K171749) focuses on an "additional surface and angle" for the PEEK Cervical Cage within the existing Velofix™ Interbody Fusion System (which had prior clearances K132926 and K140864).

The document describes pre-market clearance for a spinal implant, which is a physical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML study design (such as human reader improvement with AI assistance, training set details, and expert adjudication for ground truth) are not applicable to this submission.

However, I can extract information related to the performance testing of the device itself.

Acceptance Criteria and Device Performance Study for Velofix™ Interbody Fusion System (K171749)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the traditional sense of a clinical or imaging dataset. The "test set" here refers to the device configurations/variants subjected to Finite Element Analysis (FEA). The document doesn't specify the number of simulations run but implies that the new designs (additional surface and angle) were fully evaluated.
• Data Provenance: Not applicable for a software or AI/ML product. The "data" comes from the mechanical properties of the materials and the geometric design of the implant, used as input for the FEA.

3. Number of experts used to establish the ground truth for the test set and their qualifications

Not applicable. This is a mechanical device, not an AI/ML system requiring expert-labeled ground truth. The "ground truth" for mechanical testing is established by recognized standards (ASTM F2077) and engineering principles.

4. Adjudication method for the test set

Not applicable. Mechanical testing and FEA results are objective and compared against pre-defined engineering acceptance criteria, not subjective expert opinion.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical intervertebral fusion cage, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is not an algorithm. The "standalone performance" refers to the mechanical performance of the implant itself, which was evaluated via FEA.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established mechanical testing standards (ASTM F2077) and engineering principles, specifically for static compression and static torsion. The performance of the predicate device (Velofix™ Interbody Fusion System - K132926) also serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable. (See #8)

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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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