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The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.

The provided text describes a 510(k) premarket notification for the "Choice Spine Navigation System." This submission focuses on establishing substantial equivalence to a predicate device, rather than proving the device's absolute performance against a set of de novo acceptance criteria through extensive clinical studies, as might be required for a PMA or novel device.

The context of a 510(k) submission means the "device performance" and "acceptance criteria" are viewed through the lens of demonstrating equivalence to a legally marketed predicate. Therefore, the "study" proving it meets acceptance criteria is primarily an engineering and non-clinical performance assessment against a recognized standard (ASTM F2554-10).

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) is substantial equivalence to a predicate device. This is demonstrated by showing that the new device has "nearly identical technological characteristics" and that any minor differences "do not raise any new issues of safety and effectiveness."

The specific performance testing mentioned is for positional accuracy, as this is a critical function of a surgical navigation system.

Important Note: The provided text is a summarization for FDA submission. It generally does not include the detailed numerical results from performance tests; instead, it states the conclusion that the performance was "sufficient for its intended use" and "substantially equivalent." Full test reports would contain the exact measurements.

Additional Information on the Study (Based on 510(k) Context)

Given this is a 510(k) submission, the "study" proving the device meets acceptance criteria is primarily a non-clinical performance study and comparison to predicates.

1. Sample sizes used for the test set and the data provenance:

   • The document explicitly states "non-clinical testing" and references ASTM F2554-10. This standard typically involves laboratory-based measurements rather than human patient data.
   • Therefore, the "test set" would consist of physical test setups or mock anatomy used to measure positional accuracy according to the ASTM standard.
   • No specific sample size for "cases" is mentioned, as it's not a clinical study on patients. The "sample size" would relate to the number of measurements taken during the laboratory testing according to the standard.
   • Data Provenance: The testing was conducted by Choice Spine, LP., based in the USA. It's non-clinical/bench testing, not retrospective or prospective patient data from specific countries.

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

   • For non-clinical performance testing like positional accuracy per ASTM F2554-10, expert consensus in the form of physical measurement standards and calibrated equipment establishes the "ground truth." There are no human experts adjudicating clinical images or outcomes.
   • The "experts" involved would be engineers and technicians trained in metrology and the use of the specified testing equipment (e.g., optical tracking systems, coordinate measuring machines) to perform the measurements according to the standard. Their qualifications would be in engineering and quality assurance/testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of clinical data (e.g., medical images) to establish a consensus ground truth.
   • For non-clinical performance testing, the "ground truth" is derived from calibrated measurement devices and the precise execution of a standardized testing protocol (ASTM F2554-10). The results are quantitative measurements.

4. 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:

   • No, an MRMC study was not conducted for this submission.
   • This device is a surgical navigation system, not an AI-assisted diagnostic imaging device. Its function is to guide physical instruments in real-time during surgery, not to interpret images or assist "human readers" in a diagnostic context.
   • Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's intended use and assessment.

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

   • The device itself is standalone in its measurement capability, but its intended use is inherently human-in-the-loop, assisting a surgeon.
   • The "performance" tested (positional accuracy) reflects the algorithm's ability to track and display positions accurately. This test is a standalone assessment of the system's mechanical and computational accuracy, independent of a specific surgical procedure or patient.

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

   • The ground truth for the positional accuracy testing is based on metrological standards and precise physical measurements obtained from calibrated equipment according to ASTM F2554-10.
   • It is not expert consensus on clinical findings, pathology, or patient outcomes data.

7. The sample size for the training set:

   • Not applicable. This device is hardware and software for surgical navigation. It's not described as an AI/machine learning device that requires a "training set" of data in the typical sense (e.g., for image classification or prediction).
   • Its functionality is based on established engineering principles (e.g., optical tracking, coordinate systems) and algorithms, not data-driven machine learning models that learn from a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of machine learning for this device.

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The Choice Spine TiGer Shark™ System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.

The Choice Spine TiGer Shark™ System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, or lateral approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.

This document is a 510(k) summary for the Choice Spine TiGer Shark™ System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, and standalone performance) is not available within the provided text.

The document discusses the following types of non-clinical testing performed:

• Static Compression - Per ASTM F2077
• Static Compression Shear - Per ASTM F2077
• Dynamic Compression - Per ASTM F2077
• Dynamic Compression Shear - Per ASTM F2077
• Expulsion - N/A
• Subsidence - per ASTM F2267

It states that "Mechanical testing was conducted to prove that the new worst-case design is stronger, and after including all other similarities, shown to be equivalent to the predicate devices in safety, effectiveness, and performance." However, it does not specify the acceptance criteria for "stronger" or "equivalent," nor does it present the numerical results of these tests.

In summary, the provided text does not contain the information necessary to complete the requested table and study details.

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The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetherethertone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582). The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants. The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The provided document is a 510(k) premarket notification for the Acapella Cervical Spacer System, which is an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance in diagnosis or treatment.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
2. Sample size used for the test set or data provenance for such a study.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How the ground truth for the training set was established.

Instead, the performance data presented is focused on mechanical testing to demonstrate the structural integrity and equivalence of the device.

Here's the information that is available in the document regarding the device's technical performance:

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document states: "The results of this non-clinical testing show that the strength of the Cervical Spacer System is substantially equivalent to the legally marketed predicate devices." This implies that the acceptance criteria for these mechanical tests were that the device's performance should be comparable or equivalent to the predicate devices. Specific numerical acceptance criteria are not provided, nor are the specific numerical results of the tests.

Study Details (Mechanical Testing):

• Type of Study: Non-clinical mechanical testing.
• Tests Performed:
  • Static axial compression per ASTM F2077-11
  • Static compressive shear per ASTM F (standard number incomplete in document)
  • Static torsion per ASTM F2077-11
  • Static subsidence per ASTM F2267-04
  • Static expulsion per ASTM F-04.25.02.02 (draft)
  • Dynamic axial compression bending per ASTM F2077-11
  • Dynamic compressive shear per ASMT F2077-11
  • Dynamic torsion per ASTM F2077-11
  • Custom static tension testing
• Sample Size: Not specified for each test.
• Data Provenance: Not applicable in the context of mechanical testing.
• Ground Truth: The "ground truth" for mechanical testing is established by the specified ASTM standards, which define the testing methodology and expected performance characteristics for such devices.
• Training Set: Not applicable as this is not an AI/algorithm-based device and no training set would be used for mechanical testing.
• Adjudication/Multi-reader/Standalone: Not applicable for mechanical testing.

In summary, this document demonstrates substantial equivalence through mechanical testing according to recognized standards, rather than through clinical studies involving diagnostic accuracy or clinical outcomes.

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