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The Whistler Modular Pedicle Screw 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 and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Whistler Modular Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Whistler Modular Pedicle Screw System is provided in both non-sterile and sterile forms. All implants are intended for single use only.

The provided document is a 510(k) Premarket Notification from the FDA for the Whistler Modular Pedicle Screw System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information regarding an AI/ML-driven device or studies proving its performance against acceptance criteria in the context of diagnostic accuracy, image analysis, or similar AI-related applications.

Instead, this document focuses on a physical medical device (pedicle screw system) and its mechanical performance testing to demonstrate substantial equivalence to existing devices. The performance data listed (Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending, Static A-P load) are standard mechanical tests for spinal implants, not AI performance metrics.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves a device meets acceptance criteria in an AI/ML context using the provided text. The document is entirely about a hardware implant.

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The Vail ALIF Buttress Plate System in conjunction with tradition is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region 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 Vail ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Titanium Alloy 6AL-4V ELI per ASTM F136. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Vail ALIF Buttress Plate System is provided non-sterile, for single use only.

This is a 510(k) premarket notification for a medical device (Vail ALIF Buttress Plate System), not a study evaluating software or AI performance. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies of AI/software devices, is not available in this document.

The document describes the device, its intended use, and compares it to predicate devices based on design and material. It also mentions "performance data" but these refer to mechanical tests of the physical implant, not clinical or algorithmic performance from a study.

Here's a breakdown of what is provided regarding "performance data" in this document:

• Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of an AI/software device. The document states:
  • Acceptance Criteria for the Vail ALIF Buttress Plate System: "met all specified criteria" for "Static Cantilever Bending" and "Dynamic Cantilever Bending." The specific numerical criteria are not detailed in this summary but would have been part of the full 510(k) submission.
  • Reported Device Performance: The device withstood static and dynamic cantilever bending without failure, demonstrating "a safety and effectiveness profile that is equivalent to the predicate device."
• Study That Proves the Device Meets the Acceptance Criteria: The study mentioned is a series of mechanical performance tests, specifically:
  • Static Cantilever Bending
  • Dynamic Cantilever Bending
  • No details about the sample size (number of devices tested), data provenance, or explicit ground truth are provided, as these are material and mechanical tests, not clinical efficacy studies or AI performance evaluations.

The remaining requested information (2-9) is not applicable or present in this 510(k) summary because it pertains to the evaluation of AI/software performance, which this device is not.

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The Anterior Cervical Plate System is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications; degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Anterior Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter-length combination. Plates are available in a variety of lengths.

This document is a 510(k) premarket notification for a medical device called the Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding AI/algorithm performance, detailed study design, and expert review is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a bench testing study, not a clinical study with patient data. The "sample size" would refer to the number of physical constructs tested, but this specific number is not provided, only that the "worst case" construct was tested.
• Data Provenance: Not applicable. This refers to bench test results in a lab environment.

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

• Not applicable. This was a mechanical bench test against a standard, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set to adjudicate.

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 not an AI/algorithm-driven device. It is a physical implant.

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

• Not applicable. This is not an AI/algorithm-driven device.

7. The type of ground truth used

• Mechanical Performance Standards: The ground truth for performance was established by recognized mechanical testing standards (ASTM F1717) and comparison to the predicate device's established performance.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-driven device. There is no "training set."

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

• Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria was a bench testing study. The purpose of this study was to demonstrate substantial equivalence of the Anterior Cervical Plate System to a legally marketed predicate device (Synthes Anterior CSLP System, K030866).

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the mechanical performance of the subject device, when tested according to ASTM F1717 (covering static compression bending, torsion, and dynamic compression bending), would be comparable or equivalent to the predicate device.
• Device Performance: The study reported that "The mechanical test results demonstrated that the Subject device is substantially equivalent to the predicate devices."
• Test Conduct: The testing was performed on the "worst case Anterior Cervical Plate construct."
• Ground Truth: The "ground truth" for the mechanical performance comparison was the established performance characteristics of the predicate device and the requirements of the ASTM F1717 standard.
• Purpose: The overall conclusion was that the Anterior Cervical Plate System has the same intended use, identical indications for use, similar technological characteristics and materials as its predicate(s), and minor differences do not raise new safety or efficacy concerns after bench testing.

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This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) Premarket Notification for a Lumbar Interbody Fusion System. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. This document is for a traditional medical device (an implant) and the performance data described are related to mechanical testing, not a clinical study to evaluate diagnostic accuracy or human reader performance.

Therefore, many of your requested points are not applicable to the information provided in this document. I will fill in what I can and note where the information is not present.

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

Note: The document states that "The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to its predicate device(s)." This means the performance met the thresholds demonstrated by the predicate devices or relevant standards. Specific numerical acceptance values and actual measured performance data are not provided in this summary.

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 applicable. This document describes mechanical bench testing of an implant, not a clinical study with a "test set" of patient data. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by the ASTM standards.
• Data Provenance: Not applicable. The data comes from bench testing in a laboratory setting, not clinical data from patients.

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. This device is an implant, and its performance is evaluated based on engineering and mechanical standards, not expert interpretation of diagnostic images or clinical outcomes in the context of an AI/ML device.

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

• Not applicable. No expert adjudication method is mentioned as this is not an AI/ML device or a diagnostic study.

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

• No. This is not an AI/ML medical device. No MRMC study was conducted.

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

• No. This is not an AI/ML medical device.

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

• Not applicable in the sense of clinical ground truth for an AI/ML device. The "ground truth" for this device's performance is defined by established engineering and mechanical testing standards (ASTM F2077-14 for mechanical properties, ASTM F2267-04 for subsidence, and a "widely accepted and validated methodology" for expulsion).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cervical Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) and tantalum (per ASTM F560) implants which are designed for implantation via an anterior cervical approach. The Cervical Interbody Fusion System is comprised of various sizes to accommodate individual patient anatomy. The implants are single use and the system is provided non-sterile.

I am sorry, but the provided text describes a Cervical Interbody Fusion System, which is a medical device used for spinal fusion. The text details its regulatory classification, indications for use, materials, and non-clinical performance testing (e.g., static and dynamic axial compression, subsidence, expulsion).

The text does not contain any information about an AI-powered diagnostic device or a study involving human readers, ground truth establishment by experts, or any data provenance related to AI model testing. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI device, as the provided document is not relevant to that type of information.

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