Search Results

The Quantum-MIS Cannulated System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.

The Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (T1 - S2), posterior hook (TI-L5) sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The Quantum Spinal System (including MIS) consists of a variety of rods, fixed and polyaxial screws, transverse connectors, and locking caps used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The Quantum Spinal System (including MIS) are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic and/or lumbar spine. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The Quantum Spinal System (including MIS) components are comprised of Titanium Alloy Ti6A14V per ASTM F136. A subcomponent of the locking cap, a spring clip, is comprised of nitinol (NiTi) per ASTM F 2063. All components of the Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) are comprised of Titanium Alloy Ti6Al4V per ASTM F136 and have a hydroxyapatite (HA) coating.

The purpose of this submission is to include HA coated pedicle screws to the Quantum Spinal System (including MIS).

This document describes the acceptance criteria and the study conducted for the Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated). This is a medical device, and the evaluation for substantial equivalence to a predicate device is based on non-clinical mechanical tests, not an AI/algorithm-based system. Therefore, many standard AI/ML study components (like sample sizes for test/training sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable.

Here's the breakdown based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly states that the performance met the criteria by concluding "the subject device demonstrates substantial equivalence to the listed predicate devices" based on the performed mechanical tests. Specific numerical acceptance criteria are not detailed in this summary.

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

Since this is a mechanical device evaluation, the "test set" refers to the physical devices and components subjected to testing, not a dataset of patient information.

• Sample Size for Test Set: Not explicitly stated as a number of devices/components, but the described tests would have involved multiple samples to ensure reproducibility and statistical significance.
• Data Provenance: The tests were conducted by the manufacturer, Pioneer Surgical Technology. The data is based on laboratory mechanical testing (non-clinical) of prototype or production-representative devices. There is no information about country of origin of data or retrospective/prospective in the context of patient data.

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

• Not Applicable. This is a mechanical device. "Ground truth" in this context would be physical measurements and engineering analyses, not expert medical opinion on clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, there's no "adjudication" in the sense of reconciling expert opinions on medical cases. The evaluation is based on objective mechanical testing results against engineering standards and comparison with predicate devices.

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

• No. This is a medical device, not an AI/algorithm. MRMC studies are used for evaluating diagnostic software/algorithms.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards and Predicate Device Comparison: The "ground truth" for the device's performance is its ability to withstand specific forces, torques, and cycles as demonstrated by the mechanical tests (Pedicle Screw Insertion and Removal Torques, Static Flexion-Extension Test, Dynamic Flexion-Extension) and its equivalence to the previously cleared predicate devices in terms of material properties and performance. Compliance with FDA guidance for hydroxyapatite-coated implants also serves as a "ground truth" for material safety and performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI/algorithm.

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

• Not Applicable. This is a medical device, not an AI/algorithm. Design and manufacturing processes are iteratively developed and tested against engineering specifications, but there isn't a "training set" in the machine learning sense.

Ask a specific question about this device

The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The Quantum Spinal System components are non-cervical spinal fixation devices. Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.

The provided 510(k) summary for the K080518 Quantum Spinal System does not contain information on acceptance criteria for a device, diagnostic or AI algorithm, nor a study proving it meets such criteria. Instead, it describes a medical device (spinal fixation system) and its intended use, material, and regulatory classification.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance data (e.g., mechanical testing) for spinal implants, rather than clinical performance data from studies involving human subjects in the way an AI/diagnostic device would be evaluated.

Therefore, I cannot provide the requested information in the table format or answer the specific questions related to AI/diagnostic device evaluation, as these details are not present in the provided text.

The "Performance Data" section states: "Testing per recognized ASTM standards was presented." This refers to laboratory-based mechanical and materials testing according to established engineering standards for medical implants. These tests usually evaluate properties like fatigue strength, pull-out strength, and corrosion resistance, which is different from a diagnostic performance study.

Ask a specific question about this device

The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Not Found

This document describes the Quantum Spinal System, a medical device, and its regulatory clearance through the 510(k) pathway. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way that an AI/ML device submission would.

The provided text describes a traditional medical device (spinal fixation system) and its substantial equivalence to predicate devices, rather than an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested fields are not applicable to the information contained in the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in a quantifiable way typical for AI/ML device performance. The document states:

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

• Not applicable / Not provided. This document describes a spinal implant, not a data-driven device that requires a "test set" in the AI/ML sense. The performance data refers to mechanical and material testing, not clinical data sets.

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

• Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This information is not relevant to the clearance of a spinal implant.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in labeling data. This is not pertinent to the current device.

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 / Not provided. This device is a surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable / Not provided. There is no algorithm for this device.

7. The type of ground truth used:

• Not applicable / Not provided. The "ground truth" for a spinal implant's safety and effectiveness is established through engineering testing (e.g., biomechanical strength, material compatibility), pre-clinical studies, and clinical experience with similar predicate devices, rather than a "ground truth" for data labeling. The regulatory decision is based on substantial equivalence to predicate devices which have an established safety and effectiveness profile.

8. The sample size for the training set:

• Not applicable / Not provided. This device does not involve machine learning; therefore, there is no "training set."

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a traditional medical device (spinal fixation system). The regulatory review for such devices focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering performance data (e.g., mechanical testing conforming to ASTM standards), material safety, and similarity in design and intended use. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML devices, involving test sets, ground truth, experts, and reader studies, are not applicable to this type of traditional device clearance.

Ask a specific question about this device

The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

The Quantum Spinal System components are non-cervical spinal fixation devices. The Pioneer Quantum Spinal System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated. Material: Biocompatible alloys in conformance with ASTM Standard Specifications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum Spinal System:

This device, the Quantum Spinal System, is a Class III medical device (Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System and Pedicle Screw Spinal System). For Class III devices, especially those going through a 510(k) pathway, clinical studies are not typically the primary means of demonstrating safety and effectiveness but rather substantial equivalence to a predicate device.

Therefore, the information provided focuses on the technical performance testing rather than a clinical study involving human patients and outcomes data in the way one might expect for a digital health or diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for this type of device often provides a high-level overview. Detailed numerical acceptance criteria (e.g., specific fatigue cycles or load limits) and their exact results are contained within the full 510(k) submission, which is not fully provided in this extract. The summary confirms that such testing was performed and met the necessary standards for substantial equivalence.

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

This document describes a spinal implant, not an AI/software device. Therefore, the concept of a "test set" in the context of diagnostic performance or AI model validation does not apply.

• Sample Size: The "testing per recognized ASTM standards" refers to mechanical and material testing of the device components. The sample size would be dictated by the specific ASTM standards for mechanical testing (e.g., number of implants tested for fatigue, static bending, etc.). This information is not explicitly detailed in the provided summary but would be part of the full submission.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to engineering testing conducted by the manufacturer according to regulatory standards. This is not retrospective clinical data or prospective clinical data from human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a spinal implant device cleared via a 510(k) pathway, "ground truth" is established through:

• Engineering specifications and recognized standards (ASTM): These define acceptable mechanical properties, material composition, and biocompatibility.
• Comparison to a legally marketed predicate device: The safety and effectiveness are largely based on demonstrating equivalence to an already approved device.
• Pre-clinical testing: This may include bench testing, cadaveric testing, and potentially animal studies, but not typically human clinical expert-driven ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Adjudication methods (like 2+1, 3+1) are common in clinical trials or diagnostic studies where there's variability or disagreement among human readers or experts, which is not the case for the type of engineering performance data this device relies upon for 510(k) clearance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess the impact of AI on human reader performance. For a spinal implant, the effectiveness is demonstrated through its mechanical stability, biocompatibility, and intended use as a fixation device, and implicitly, the established safety and effectiveness of its predicate device.

6. Standalone (Algorithm Only) Performance

No, standalone performance is not applicable. The Quantum Spinal System is a physical medical device (spinal implant), not a software algorithm or an AI device.

7. Type of Ground Truth Used

The "ground truth" for this device's clearance via the 510(k) pathway is primarily:

• Engineering Standards and Specifications: Meeting the requirements of recognized ASTM standards for mechanical strength, fatigue, and material properties.
• Predicate Device Equivalence: The safety and effectiveness are established by demonstrating that the device is substantially equivalent to a previously cleared legally marketed device (K041167) in terms of materials, performance, and indications for use.
• Biocompatibility Data: Conformance to ASTM standards for biocompatible alloys.

There is no mention of expert consensus from clinical cases, pathology, or specific patient outcomes data being used as "ground truth" for the 510(k) process outlined in this summary.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The concept of a "training set" is not relevant here.

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

Not applicable. See point 8.

Ask a specific question about this device

The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) or as an anterolateral fixation system (T8 – L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

Quantum Spinal System

This document is a 510(k) premarket notification for the Pioneer Quantum Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Therefore, I cannot provide the requested information. The document explicitly states:

"Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence."

This indicates that the submission relied on comparing the new device to existing, legally marketed devices rather than presenting novel performance studies against predefined acceptance criteria for the Quantum Spinal System itself.

Ask a specific question about this device