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The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC cages are made of PEEK (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations. The SteriSpine™LC range of products is supplied sterile with a sterile single-use set of surgical instruments.

The provided text is a 510(k) summary for the STERISPINE™ LC CAGE device. It largely focuses on demonstrating substantial equivalence to predicate devices, particularly concerning changes to surgical instruments and packaging, rather than presenting a performance study for the device itself or an AI component.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document. The device in question is an intervertebral body fusion device, not an AI/ML powered device. The document describes non-clinical tests conducted to support substantial equivalence for modifications to the device's instruments and packaging, not a study to prove meeting acceptance criteria for a device's performance in a clinical setting.

Below is an attempt to answer the questions based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable and not available for the type of testing described (non-clinical tests for substantial equivalence of device modifications, not a clinical performance study with a test set of data). The testing was for biocompatibility, packaging validation, and sterilization revalidation of materials and processes.

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

This information is not applicable and not available. The document refers to non-clinical tests (biocompatibility, packaging, sterilization) and not a study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not available. The testing described does not involve an adjudication method for a test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for an intervertebral body fusion device and did not involve an AI component or analysis of human reader performance.

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

A standalone performance study was not done. This submission is for an intervertebral body fusion device and did not involve an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. The non-clinical tests (biocompatibility, packaging, sterilization) did not utilize ground truth in the context of clinical expert consensus, pathology, or outcomes data. Ground truth, in this context, would be compliance with the specified ISO standards for the respective tests.

8. The Sample Size for the Training Set

This information is not applicable and not available. The document describes non-clinical tests for device modifications, not an AI/ML model for which a training set would be used.

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

This information is not applicable and not available. As there is no AI/ML model or training set, the concept of establishing ground truth for a training set does not apply.

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The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity that is filled with bone graft (autograft) to facilitate fusion. The SteriSpine™LC is available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC is made of (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations.

The provided text describes a 510(k) premarket notification for a medical device (SteriSpine™LC Lumbar Cage), which is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve clinical studies with human participants to establish the device's performance against detailed acceptance criteria in the way that, for example, an AI diagnostic tool would be evaluated. Instead, it relies on non-clinical (bench) testing to show that the new device performs similarly to existing, cleared devices.

Therefore, many of the requested categories in your prompt are not applicable or would be misleading if forced into the context of this 510(k) submission. I will address the relevant information provided and explain why other sections are not present.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This submission focuses on non-clinical, bench testing of the device's mechanical properties, not on a "test set" of patient data or clinical outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized test methods (e.g., ASTM standards) and engineering principles, not expert consensus on clinical data.

4. Adjudication method for the test set: Not applicable.

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 a physical intervertebral fusion device, not an AI diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by the performance characteristics of the legally marketed predicate devices and established ASTM standards for intervertebral body fusion devices. The goal is to demonstrate "substantial equivalence" in mechanical performance.

8. The sample size for the training set: Not applicable. This refers to a "training set" in the context of machine learning or AI. For a physical medical device, there is typically a design and development process that involves iterative testing and refinement, but not a "training set" in this sense.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study and Device Performance:

The study referenced in the 510(k) submission (K133893) for the SteriSpine™LC Lumbar Cage is a non-clinical performance testing study. The purpose of this study was to demonstrate that the SteriSpine™LC device is substantially equivalent to previously cleared predicate devices in terms of safety and effectiveness.

The testing involved:

• Static axial compression
• Dynamic axial compression
• Static compression shear testing
• Dynamic compression shear testing (according to ASTM F2077)
• Subsidence testing (according to ASTM F2267)
• Expulsion testing (according to an in-house protocol)

Result: The results of these tests demonstrated that the SteriSpine™LC performs as safely and effectively as previously cleared devices. The conclusion states that the device is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties, and function, with minor differences not raising new safety or effectiveness issues.

Data Provenance: The data provenance for this non-clinical testing is the internal laboratory testing conducted by SafeOrthopaedics to meet regulatory requirements and demonstrate substantial equivalence to the selected predicate devices (K122021, K094025, and P960025). The data is from mechanical bench testing, not from any clinical data set or country of origin in that sense.

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The STERISPINE™ LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with STERISPINET™ PS a supplemental fixation system cleared, by the FDA for use in the lumbar spine

SteriSpine™LC range of products consists of lumbar Interbody fusion devices available in sizes to adapt to anatomical variations. SteriSpine™LC is dedicated to transforaminal approach and is manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F560-08 are used to visualize the position of the implant in the disc space. STERISPINE LC Lumbar Interbody Devices are supplied sterile with a single-use set of surgical instruments.

Here's an analysis of the provided text regarding the STERISPINE LC device's acceptance criteria and study information:

Key Takeaway: The STERISPINE LC device's acceptance criteria and studies are focused on demonstrating mechanical equivalence to predicate devices. There is no clinical data presented in this 510(k) summary, meaning no studies assessing AI performance, human reader improvement, or standalone algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly met by achieving "comparable mechanical properties to the predicate device." The submission does not specify numerical thresholds for these properties but rather relies on a comparative assessment.

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

• Test Set Sample Size: Not applicable. The provided document details mechanical and cadaveric testing, not clinical studies or AI model evaluations with a "test set" of patient data.
• Data Provenance: Not applicable. The studies are non-clinical mechanical tests and cadaveric studies, not involving patient data from specific countries or types of studies (retrospective/prospective).

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus. For cadaver testing, the "ground truth" would be the successful validation of instrument function, likely assessed by surgeons or relevant technical personnel, but no specific number or qualifications are mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept is relevant for clinical or diagnostic studies involving human interpretation or consensus, which are not described here.

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

• MRMC Study Done? No. The submission explicitly states: "No clinical data has been presented." Therefore, no MRMC study assessing human reader improvement with or without AI assistance was performed or presented.

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

• Standalone Study Done? No. This device is an intervertebral body fusion device (an implantable medical device), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • For Mechanical Testing: The ground truth is based on established engineering standards (ASTM F2077-03, ASTM F2267-04) and the mechanical properties of the legally marketed predicate devices (Lumbar I/F cage manufactured by Depuy Acromed and Zavation IBF System manufactured by Zavation LLC).
  • For Cadaver Testing: The ground truth is the successful validation of the instrumentation's function in a simulated surgical environment (cadavers).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no training set mentioned or relevant in this context.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

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