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When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic, lumbar and sacral level. When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic and lumbar level. When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below. Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)

General system description. The SCS Spinal System includes implantable components which fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of three defined intended uses and to fit the patient's anatomical and physiological requirements. Materials. Materials for components of the SCS Spinal System are implant grade materials of titanium or stainless steel. The materials comply with applicable standards shown below: Titanium Alloy ASTM F136-92 ISO 5832-3 Titanium ASTM F67 GR2-95 ISO 5832-2 316LVM ASTM F138 GR2 ISO 5832-1 The system components include: Lumbar, thoracic, and pedicular hooks Vertebral screws, open vertebral screws, set screws, and pedicle screws (including self-locking) Rods in various lengths Connectors with set screws (sacral, anterior, transverse, lateral) Connecting elements (longitudinal connectors) Instruments Sterilizer trays

The provided text describes a medical device, the SCS Spinal System, and its regulatory clearance. It does not contain information about studies evaluating its performance against specific acceptance criteria in a way that would typically be described for AI/software-as-a-medical-device (SaMD) products. The document is a 510(k) premarket notification for a Class II medical device, which primarily demonstrates substantial equivalence to a predicate device rather than presenting novel performance studies for de novo clearance.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a physical implantable device.

However, I can extract the acceptance criteria as described for the device's characteristics and the studies that demonstrate compliance with those criteria.

Here's the information gleaned from the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Titanium Alloy: ASTM F136-92, ISO 5832-3
• Titanium: ASTM F67 GR2-95, ISO 5832-2
• 316LVM: ASTM F138 GR2, ISO 5832-1"
  The comparison table also states "Material: Stainless steel, titanium alloy, pure titanium" and "SAME" as predicate, indicating compliance. |
  | Mechanical Testing (Special Control) | Compliance with mechanical testing standard for spinal systems (specifically, ASTM F-1717 as a guideline for fatigue testing). The predicate device's design is "SAME" and its performance is assumed equivalent. Run-out points exceeding 5,000,000 cycles. | "Fatigue testing of a typical system configuration was conducted on samples of both stainless steel and titanium. Samples were tested using ASTM F-1717 as a guideline. Samples were tested for each load configuration. At least two run out points exceeded 5,000,000 cycles for each material." |
  | Biocompatibility (Special Control) | Compliance with biocompatibility standards (implied, as materials are implant grade and "SAME" as predicate). | Not explicitly detailed in the provided text beyond stating "Compliance with biocompatibility standard" as a special control and confirming the use of "implant grade materials." The use of standard implant materials (titanium, stainless steel) implies accepted biocompatibility. |
  | Labeling (Special Control) | Compliance with specified labeling requirements, including warnings and precautions for pedicle screw spinal systems (e.g., "Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation... The safety and effectiveness of these devices for any other conditions are unknown." and "Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons..."). Additionally, general labeling requirements of the Act (e.g., 21 CFR Part 801). | The document states "Compliance with specified labeling requirements" as a special control and explicitly lists the mandatory warning and precaution statements that must be included in the labeling for pedicle screw spinal systems. This indicates the device's labeling will meet these criteria. |
  | Sterility (Device Condition) | Supplied "NON-STERILE." Recommended sterilization process is high temperature steam autoclave sterilization, validating a Sterility Assurance Level (SAL) of at least 10^-6. Validated cycle: Steam (Gravity), 250°F (121°C), 30 minutes exposure time. Must be handled, stored, and opened to prevent damage or contamination. | "The SCS Spinal System is supplied 'NON-STERILE' and must be sterilized prior to use. The recommended sterilization process is high temperature steam autoclave sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10^-6. The validated cycle is: Method: Steam, Cycle: Gravity, Temperature: 250°F (121°C), Exposure Time: 30 minutes." Instructions for handling and storage are provided to ensure product integrity. The comparison table lists "Sterile: Non-sterile" as "SAME" as the predicate. |
  | Indications for Use (Substantial Equivalence) | Indications identical or substantially equivalent to the predicate Synergy™ Spinal System for non-pedicle posterior, anterolateral/anterior, and posterior pedicle systems, covering conditions like spondylolisthesis, fracture, spinal stenosis, deformities, tumors, pseudarthrosis, and failed previous fusion. Including specific conditions for pedicle screws (degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, etc.) and L5-S1 joint spondylolisthesis (Grades 3 & 4), autogenous bone graft fusions, etc. | The "Summary Comparison Table" explicitly states "Indications for Use: SAME" for all three system types (Non-pedicle posterior, Anterolateral/anterior, Posterior pedicle) when compared to the Synergy™ Spinal System, and lists "YES" for substantial equivalence ("SE?"). The detailed indications provided for the SCS Spinal System perfectly match those implied by stating "SAME" to the predicate. |
  | Design (Substantial Equivalence) | "Hook, rod, vertebral screw, sacral screw, pedicle screw & cross link system" design. | The "Summary Comparison Table" states "Design: SAME" when compared to the predicate Synergy™ Spinal System, and lists "YES" for "SE?". |
  | Sizes (Substantial Equivalence) | Rods: 5.8-6.0mm dia. X 40-540mm length; Hooks: Small, Medium, Large, Offset, Pedicular, Transverse, Thoracic; Vertebral Screws: 5-10mm dia. X 35-50mm length; Sacral Screws: 6-7mm dia. X 30-55mm length. Expected to be "EQUIVALENT" to predicate. | The "Summary Comparison Table" states "Sizes: EQUIVALENT" when compared to the predicate Synergy™ Spinal System, and lists "YES" for "SE?". The specific size ranges are detailed in the device description. |

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

• Test Set Sample Size: The document only mentions "samples" for fatigue testing. It states, "At least two run out points exceeded 5,000,000 cycles for each material." This indicates a minimum of 2 samples per material (stainless steel and titanium) were tested, but doesn't provide the total number of samples or configurations beyond that.
• Data Provenance: Not specified, but the applicant (ORTHOTEC, INC.) is based in Los Angeles, CA, USA. The device's "Origin" is listed as "EUROPEAN." It's unclear if the testing was performed in Europe or the US.

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

N/A. This device is a physical implant. The "ground truth" for its performance is based on engineering mechanical tests and material standards, not expert assessments of clinical outcomes or image interpretations. Clinical outcomes or expert consensus would typically be relevant for studies evaluating diagnostic or AI-driven devices.

4. Adjudication method for the test set

N/A. This concept is not applicable to the mechanical and material testing described for a physical implant.

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

N/A. MRMC studies are relevant for diagnostic devices, especially those incorporating AI, and involve human readers interpreting cases. This submission is for a spinal implant.

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

N/A. This concept is relevant for AI/SaMD devices. The SCS Spinal System is a physical implant.

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

The "ground truth" for the SCS Spinal System's performance is established through:

• Compliance with material standards (e.g., ASTM F136-92 for Titanium Alloy).
• Compliance with mechanical testing standards (e.g., ASTM F-1717 guidelines for fatigue testing, with a specified performance target of exceeding 5,000,000 cycles).
• Demonstration of substantial equivalence to an already cleared predicate device (Synergy™ Spinal System) regarding indications for use, design, materials, and (equivalent) sizes.

8. The sample size for the training set

N/A. This device does not involve a training set as it is not an AI/machine learning device.

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

N/A. Not applicable.

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