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The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:

• Degenerative Disc Disease (as defined by neck or back pain of discogenic origin ー with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis -
• -Spinal Stenosis
• Fracture/ Dislocation -
• -Deformities or Curvature
• -Tumors
• -Pseudoarthrosis
• -Revision of previous cervical and upper thoracic spine surgery

The use of the screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Pioneer Posterior Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, and connecting components used to build a cervico-thoracic spinal construct.

The Pioneer Posterior Cervico-Thoracic System components are manufactured from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.

The Pioneer Posterior Cervico-Thoracic System can be attached to FDA approved pedicle screw systems (e.g. Quantum® Spinal Fixation System or Streamline TL Spinal System) using parallel connectors.

The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) submission for a medical device called the Pioneer Posterior Cervico-Thoracic System. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria related to a diagnostic output or outcome.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC) does not directly apply to this 510(k) submission.

Instead, the "acceptance criteria" here revolve around demonstrating substantial equivalence to a predicate device. The "study" proving this involves mechanical testing and comparison of intended use, materials, and design.

Here's how to frame the information based on the provided document:

Acceptance Criteria and Evidence for Substantial Equivalence (for a 510(k) Submission)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: This refers to the mechanical test samples.
• Sample Size: Not explicitly stated in the document. The document mentions "Testing per recognized ASTM standards was presented (ASTM F 1717 Static and Fatigue, Compression and Torsional testing, ASTM F543 Screw Insertion and Screw Pullout testing)." ASTM standards usually specify sample sizes for such tests, but the specific number of units tested is not provided in this summary.
• Data Provenance: The provenance is from internal testing conducted by the manufacturer, Pioneer Surgical Technology. The document does not specify country of origin for the data beyond that. This is a pre-clinical (bench-top) study, not a clinical study involving patients.

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

• Not Applicable. For a mechanical performance test establishing substantial equivalence for an orthopedic implant, "experts" in the sense of clinicians establishing ground truth (e.g., radiologist for imaging) are not used. The "ground truth" is typically defined by the test standard (e.g., ASTM F1717 specifies how fatigue testing should be conducted and what constitutes failure).

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing to established standards, there is no adjudication process involving human interpretation of results in the way there would be for a clinical diagnostic study. The tests are designed to produce quantifiable, objective results against specified criteria.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists interpreting images, assisted by AI). This 510(k) submission is for an orthopedic implant, where the primary evidence presented for substantial equivalence is mechanical testing and design/material comparison.

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

• Not Applicable. This device is a surgical implant, not an algorithm or diagnostic tool. The performance evaluated is the physical mechanical integrity of the implant components.

7. The Type of Ground Truth Used

• For mechanical properties, the "ground truth" is defined by the recognized ASTM standards (ASTM F 1717 and ASTM F543) which dictate the testing methodology and acceptance criteria for mechanical performance (e.g., static and fatigue strength, screw insertion and pullout forces). The objective measurements obtained during these tests are compared against the expected performance based on the predicate device.
• For intended use, materials, and design, the "ground truth" is the characteristics of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of an orthopedic implant's 510(k) submission. This refers to data used to train AI models, which is irrelevant here.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:

• Degenerative Disc Disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis
• Spinal Stenosis
• Fracture/ Dislocation
• Deformities or Curvature
• Tumors
• Pseudoarthrosis
• Revision of previous cervical and upper thoracic spine surgery
  The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
  The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Pioneer Posterior Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial screws, favored angle screws, locking caps, and connecting components used to build a cervico-thoracic spinal construct.
The Pioneer Posterior Cervico-Thoracic System components are manufactured from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.
The Pioneer Posterior Cervico-Thoracic System can be attached to Pioneer Quantum® Spinal Rod System using parallel connectors.
The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This 510(k) summary for the "Pioneer Posterior Cervico-Thoracic System" is a medical device submission seeking clearance for market, not a study report demonstrating acceptance criteria with performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

The document primarily focuses on establishing substantial equivalence to previously approved predicate devices, a common pathway for 510(k) clearance, rather than presenting a detailed performance study against specific acceptance criteria.

Here's an analysis based on the provided text, highlighting what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a performance study. The "acceptance criteria" for a 510(k) in this context is typically demonstrating substantial equivalence to predicate devices in terms of intended use, design, materials, and technological characteristics.
• Reported Device Performance: The document states "Testing per recognized ASTM standards was presented." However, it does not provide the specific results or performance values from these tests, nor does it define what values would constitute "acceptance." The performance is implicitly considered acceptable if it allows for a determination of substantial equivalence.

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

• Sample Size for Test Set: Not specified. The document refers to "Testing per recognized ASTM standards was presented," which implies mechanical or material testing, not human subject testing. The sample sizes for such engineering tests (e.g., fatigue, static strength) would be dictated by the specific ASTM standards followed, but these details are not provided.
• Data Provenance: Not applicable in the context of human data. For materials and mechanical testing, the data would originate from laboratory tests conducted by the manufacturer or a third-party lab. No information on country of origin is provided. The tests are prospective in nature (conducted for the submission), not retrospective.

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

• Not applicable. This information pertains to studies involving clinical data, image interpretation, or diagnostic device performance where expert consensus is used to establish ground truth. This 510(k) summary is for a spinal implant system and does not contain such a study.

4. Adjudication Method for the Test Set

• Not applicable. See explanation for #3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret outputs (e.g., images) and AI assists in that interpretation. The Pioneer Posterior Cervico-Thoracic System is a surgical implant; therefore, an MRMC study is not relevant to its clearance.

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

• No. Not applicable, as this is a physical medical device (spinal implant), not a software algorithm.

7. The Type of Ground Truth Used

• For the mechanical and material performance mentioned, the "ground truth" would be the engineering specifications and performance characteristics defined by the relevant ASTM standards. The device is tested against these standards to demonstrate compliance. There is no biological or diagnostic "ground truth" in this submission.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI algorithms requiring data for training.

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

• Not applicable. See explanation for #8.

In summary, the provided document is a 510(k) summary for a spinal implant, which establishes substantial equivalence based on physical and mechanical characteristics and intended use compared to legally marketed predicate devices. It references performance testing to recognized ASTM standards but does not provide specific performance data or detailed study designs that would align with the questions about acceptance criteria, clinical studies, or AI/ML evaluation.

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