Search Results

The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Intuitive Anterior Cervical System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.

The provided text describes a medical device, the "Intuitive Anterior Cervical System," and its clearance process, which relies on demonstrating substantial equivalence to a predicate device. This is not the type of study typically associated with AI/ML devices where specific acceptance criteria are defined for algorithmic performance. Instead, it focuses on physical and mechanical performance.

Therefore, many of the requested categories related to AI/ML studies are not applicable to this document. I will fill in the relevant information and indicate when information is "Not Applicable" or "Not Provided" in the context of this device's regulatory submission.

1. Table of Acceptance Criteria and the Reported Device Performance

• Static compression bending
• Static torsion
• Dynamic compression bending | "The mechanical test results demonstrated that Intuitive performs as well as the predicate device." (Implies meeting or exceeding predicate's performance in these tests, which serves as the de facto acceptance criteria.) |
  | Technological Characteristics:
• Intended Use
• Design (plate-based fixation system having self-tapping screws in various sizes)
• Material (titanium alloy)
• Sizes (plate and screw sizes) | "The Intuitive Anterior Cervical System is identical to the predicate Fixed, Variable & Corpectomy Cervical Plate System [...] Therefore, the system possesses the same technological characteristics as the predicate." |
  | Material Composition:
• Plates and screws: titanium alloy (Ti-6Al-4V per ASTM F136)
• Screw-retaining central rail: nickel titanium alloy (NiTi per ASTM F2063) | The device is manufactured from these specified materials. Implicitly, meeting these material specifications is an acceptance criterion. |

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of data for an AI/ML system. Instead, the testing refers to "a worst-case, cervical plate construct" for mechanical tests. The "sample" likely refers to the physical constructs tested according to ASTM F1717.
• Data Provenance: Not applicable in the context of patient data. The mechanical testing is laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth in the sense of expert annotation for AI/ML performance is not relevant here. The "ground truth" for the mechanical tests would be the established scientific principles of material strength and durability, and the ASTM F1717 standard itself.

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

• Not Applicable. Adjudication methods are for conflicting expert opinions in data labeling, which is not part of this type of device evaluation.

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 implant device, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not Applicable. See point 5.

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

• The "ground truth" used for this device's acceptance is based on mechanical testing standards (ASTM F1717) and the established performance of a legally marketed predicate device. The fundamental scientific principles governing material strength and biomechanics, as codified in the ASTM standard, serve as the basis for evaluating device performance.

8. The sample size for the training set

• Not Applicable. As this is not an AI/ML device, there is no "training set."

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

• Not Applicable. As this is not an AI/ML device, there is no "training set" and thus no ground truth established for it.

Ask a specific question about this device

The PSL Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

The PSL Anterior Cervical Plate (ACP) System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.

This document describes a 510(k) premarket notification for the "PSL Anterior Cervical Plate System". It's a medical device, specifically a spinal implant, which means the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of characteristics, rather than clinical efficacy studies often associated with AI/software devices.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Testing: "worst-case, cervical plate construct" - The document does not specify the exact number of constructs tested, but implies a sufficient number for an engineering study to demonstrate performance against the predicate.
• Data Provenance: The mechanical tests were performed by the manufacturer (Precision Surgery Limited) or a contracted lab. This is a prospective engineering study, not involving human data. There is no country of origin of data in the same sense as clinical data.

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

This is not applicable in the context of this device. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and direct comparison to the predicate device, not by expert medical consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable. This is an engineering study, not a clinical study requiring adjudication of outcomes or diagnoses.

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

No, an MRMC study was not done. This is a spinal implant, not an AI/software device that would typically involve human readers interpreting images.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence was:

• Predicate Device Performance: The established mechanical performance of the legally marketed predicate device (Fixed, Variable & Corpectomy Cervical Plate System (K032815/K073708)).
• ASTM F1717 Standard: The performance criteria defined by the standard for spinal implant mechanical testing.
• Direct Comparison of Characteristics: Comparing the design, materials, intended use, and sizes directly to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Precision Surgery Limited Fixed, Variable & Corpectomy Cervical Plate System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.

The provided text is a 510(k) summary for the "Fixed, Variable & Corpectomy Cervical Plate System." This document describes a medical device, specifically a spinal implant, and seeks substantial equivalence to a predicate device. It does not present a study with acceptance criteria and reported device performance in the context of an "AI" or "diagnostic" device. Instead, it describes a traditional medical device (a cervical plate system) and its substantial equivalence to a previously cleared device based on design, intended use, indications, anatomic sites, and performance (which likely refers to mechanical and biocompatibility testing, not clinical performance metrics in the way a diagnostic device would have).

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and submission described in the provided text.

The closest information provided is regarding the overall device description and its intended use, which are established for mechanical devices through different types of testing (e.g., biomechanical, material characterization) rather than clinical performance studies with diagnostic metrics.

If this were a diagnostic device, I would expect to see details about sensitivity, specificity, accuracy, or other relevant performance metrics, along with the study design to evaluate these. As that is not the case here, I can only extract information that is present.

Ask a specific question about this device