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The Genesys Spine Anterior Buttress Plate system in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

The Genesys Spine Anterior Buttress Plate System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine buttress plate and screws that are inserted into the anterior surface of adjacent lumbar vertebrae.

This document describes the Genesys Spine Anterior Buttress Plate System, a medical device, and its acceptance criteria for FDA clearance. The information provided heavily focuses on the mechanical performance testing of the device for substantial equivalence with predicate devices, rather than an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies are not applicable or cannot be extracted from this document.

Here's the breakdown of the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical sample size. The document mentions "all possible configurations of the Anterior Buttress Plate System construct were analyzed in order to determine the worst case to be used for testing." It then states that "Static and dynamic cantilever bending testing... were then performed on the worst case Anterior Buttress Plate System construct." This implies that one "worst-case" construct (or a representative number of units of that construct) was tested. Specific numbers of units tested are not provided.
• Data Provenance: The data is based on mechanical testing of the device, not clinical or image-based data from human subjects. Therefore, country of origin or retrospective/prospective classification is not applicable in the typical sense for patient data.

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

• This question is Not Applicable (N/A). The ground truth for this device's performance is established through objective mechanical engineering standards (ASTM F1717) and comparison to predicate devices, not through expert human interpretation of data.

4. Adjudication Method for the Test Set

• This question is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on clinical data (e.g., image interpretation). This study relies on objective mechanical testing results.

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

• This question is Not Applicable (N/A). This is a study of a physical medical implant (spinal plate), not an AI-based diagnostic or assistive device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This question is Not Applicable (N/A). This device is a physical implant, not an algorithm. Its performance is evaluated through mechanical testing, which is inherently "standalone" in the sense that it doesn't involve human interaction during the test itself, but it's not an algorithm.

7. Type of Ground Truth Used

• The ground truth used is based on objective mechanical performance standards (ASTM F1717) and the established mechanical properties of legally marketed predicate devices. The goal was to prove "equivalence to (or greater than)" these predicate devices.

8. Sample Size for the Training Set

• This question is Not Applicable (N/A). This is not an AI/ML device that requires a training set. The device's design is based on engineering principles and existing predicate devices.

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

• This question is Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question does not apply.

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The Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing applications.

The Black Widow Anterior Buttress Plate is designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. Specific system features include: Plate uniquely shaped to conform to anterior spine anatomy. Two peas which engage the vertebral body and prevent rotation. An extremely low profile plate with a full radius around the perimeter and a screw that sits flush with the anterior surface of the staple. A self-tapping screw in multiple lengths. The devices are manufactured from Ti6Al4V per ASTM F136. The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

The provided text describes a medical device submission (K081770 for the Black Widow Anterior Buttress Plate System) to the FDA. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria, expert adjudication, or AI performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not applicable to this document because it describes a mechanical device that underwent mechanical testing for substantial equivalence, not a machine learning or AI-driven diagnostic device.

Here's why the specific questions cannot be answered from the provided text:

• Acceptance Criteria & Reported Performance: The document states that "Mechanical test results, conducted in accordance with ASTM F1717, demonstrate that the Black Widow Anterior Buttress Plate System is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or exact device performance values from these mechanical tests. It only states the conclusion of substantial equivalence.
• Sample Size (Test Set) & Data Provenance: This pertains to clinical or imaging data. As this is a mechanical device, no such "test set" of clinical data was used for evaluation in this submission.
• Number of Experts, Qualifications & Adjudication Method: These are relevant for studies involving human interpretation or clinical outcomes. They are not applicable to the mechanical testing performed for this device.
• MRMC Comparative Effectiveness Study: This is specific to AI or diagnostic imaging studies comparing human reader performance with and without AI. Not applicable here.
• Standalone Performance (Algorithm Only): This refers to AI algorithm performance without human intervention. Not applicable as no AI is involved.
• Type of Ground Truth: Ground truth (e.g., pathology, expert consensus) is established for clinical conditions or diagnostic accuracy. For a mechanical device, the "ground truth" would be engineering specifications and physical properties, which are evaluated through mechanical tests (like ASTM F1717).
• Sample Size (Training Set): This refers to data used to train AI models. Not applicable as no AI is involved.
• How Ground Truth for Training Set was Established: Again, not applicable as no AI training occurred.

In summary, the provided document from a 510(k) premarket notification for a spinal implant describes mechanical testing for substantial equivalence, not an evaluation of an AI or diagnostic device that would involve the specific criteria outlined in your request.

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The Scient'X Anterior Buttress Plate is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The Anterior Buttress Plate is a graft containment device that features a Ti plate fixed by a vertebral body screw. The Ti plate is connected to a PEEK buttress that extends over the adjacent intervertebral space maintaining the position of the bone graft.

The provided text is for a 510(k) summary for a medical device (Scient'X Anterior Buttress Plate), which falls under the category of spinal implants. These summaries are typically for demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than clinical studies with human subjects or AI performance metrics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI standalone performance, training set size) are not applicable to this type of regulatory submission and information will not be found in the provided document.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

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

• Not Applicable. The submission focuses on substantial equivalence based on mechanical testing and comparison to predicate devices, not on a clinical test set with human data as would be relevant for AI/diagnostic devices. The document does not specify sample sizes for mechanical tests, nor details about data provenance in the context of clinical studies.

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 consensus for diagnostic accuracy, is not relevant to this type of device submission. The primary "ground truth" for substantial equivalence would be the performance characteristics of the predicate devices.

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

• Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of results (e.g., imaging). This is a mechanical device submission.

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 medical device (spinal implant), not an AI or diagnostic tool where MRMC studies would be conducted.

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

• Not Applicable. This is a physical spinal implant, not an algorithm or AI device.

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

• The "ground truth" for this submission is the performance characteristics and safety profiles of the legally marketed predicate devices. Substantial equivalence means the new device is as safe and effective as existing devices. This would be established through mechanical testing results compared to the predicate, and possibly design comparisons.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set.

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

• Not Applicable. This is not an AI or machine learning device.

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