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The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.

The Phenix™ VBR is a rectangular implant with an open center comprised of titanium, (Ti-6Al-4V). The Phenix™ VBR's superior and inferior ends have ridges to interface with the vertebral endplates to resist rotation and migration. The implant is available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. The Titanium allows for radiographic visualization.

This document is a 510(k) premarket notification for the Phenix™ Vertebral Body Replacement (VBR) device. It is a submission to the FDA for market clearance, not a study demonstrating device performance against acceptance criteria in the manner of a clinical trial or AI algorithm validation. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative measurement sense, nor does it report specific device performance metrics against such criteria in the provided text. The "Performance Data" section merely states: "Testing was completed to characterize the device." This implies mechanical or material property tests, but no results or acceptance criteria for those tests are detailed in this document.

Therefore, a table cannot be constructed from the provided information.

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

This information is not provided because the document is a 510(k) premarket notification, not a clinical study report validating performance against specific acceptance criteria for software or an AI device. The "test set" in this context would likely refer to the physical Phenix™ VBR devices subjected to mechanical testing. The provenance of such physical tests (e.g., in a lab, specific conditions) is not detailed here.

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

Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI or diagnostic device requiring expert interpretation.

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

Not applicable. This is a physical spinal implant, not a diagnostic imaging device or an AI assistant for human readers.

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

Not applicable. This is a physical spinal implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the typical sense for medical device performance (e.g., pathology for diagnostic accuracy). The "ground truth" for a physical implant would be its adherence to design specifications, material properties, and mechanical performance under various loads, which would be assessed through engineering tests, not a "ground truth" established by experts.

8. Sample Size for the Training Set

Not applicable. This is a physical spinal implant, not a machine learning model.

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

Not applicable. This is a physical spinal implant, not a machine learning model.

Summary of Device Information from the 510(k) Application:

• Device Name: Phenix™ Vertebral Body Replacement (VBR)
• Company: Spinal Devices, LLC
• Classification: Class II
• Product Code: MQP, 888.3060 (Spinal intervertebral body fixation orthosis)
• Device Description: Rectangular implant with an open center, made of titanium (Ti-6Al-4V). Features ridges on superior and inferior ends for vertebral endplate interface. Available in various sizes, flat and lordotic angles. Radiographically visible.
• Intended Use: For use in the thoracic spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies resected due to tumor or trauma (fracture). Designed to restore mechanical integrity of the spinal column. Intended for use with supplemental spinal fixation systems labeled for thoracic spine use. Can be packed with bone graft (autograft bone mentioned in the "Indications for Use Statement").
• Predicate Device: Substantial equivalence was determined based on the same indications for use, intended use, design, and performance to a predicate device (not named in the provided text).
• Performance Data: "Testing was completed to characterize the device." (No specific results or acceptance criteria are detailed in this extract).
• FDA Clearance Date: October 15, 2007 (K072029)

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The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame design.

The NBD Head Screw is a single-use threaded clear anodized aluminum screw which is manufactured in lengths ranging from 33mm-57mm.

The provided 510(k) summary for the NBD Head Screw does not contain information about acceptance criteria or a study performed to prove the device meets such criteria.

The document states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for this device." This indicates that there were no specific performance metrics or thresholds established for this device by regulatory bodies at the time of submission.

Instead of performance studies, the clearance for the NBD Head Screw was based on substantial equivalence to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as existing, legally marketed devices with similar intended use, materials, and design, rather than through meeting specific performance metrics via a new study.

Therefore, the requested information cannot be extracted from the provided text.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states there are no applicable performance standards.
2. Sample size used for the test set and the data provenance: No test set or performance study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method: Not applicable.
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 mechanical accessory, not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as this is not an algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The NBD Disposable RF Needle are indicated for use in radio frequency heat lesion procedures for relief of pain.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "NBD Disposable RF Needle." It confirms substantial equivalence to a predicate device and allows the marketing of the device. However, it does not contain any information about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes related to AI or algorithm performance studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on the technical performance data of the device itself in the context of a study.

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The NBD Cement Restrictor Device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The NBD Cement Restrictor is NOT intended for any spinal indications.

The NBD Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The provided text describes a medical device, the NBD Cement Restrictor, and its 510(k) submission to the FDA. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets, expert involvement, or comparative effectiveness studies.

The document primarily focuses on:

• Device Description: What the NBD Cement Restrictor is (hollow, titanium, rounded rectangular frame with fenestrated surfaces and spikes).
• Intended Use: As a cement restrictor in orthopedic surgeries like hip stem and total knee replacement, specifically excluding acetabular cup surgeries.
• Performance Data: States "No applicable performance standards have been promulgated," but mentions the material conforms to ISO 5832-3.
• Functional & Safety Testing: A general statement that testing "consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results were successful and did not raise any issues of safety and effectiveness of the device." This is a qualitative statement, not a detailed study with acceptance criteria.
• Substantial Equivalence: To the RA-BEATM Cement Restrictor Device (K990345), and mentions other predicate devices. This is the primary basis for FDA clearance in this case.
• FDA Communication: The FDA's clearance letter, including a specific warning against spinal indications.

Therefore, many of the requested sections cannot be filled based on the provided text.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document states "Functional and safety testing... consisted of examination of the function of the device under conditions similar to those found in normal usage" but gives no details on the sample size, specifics of the "conditions," or provenance (e.g., in-vitro, ex-vivo, animal, human, country of origin).

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/Not provided. The device is a physical implant, not an AI or diagnostic device that requires expert-established ground truth for a test set in the conventional sense. The "testing" mentioned is likely engineering/bench testing.

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

• Not applicable/Not provided. This refers to consensus-building among experts, which is not described for the functional/safety testing of this physical device.

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 a physical medical device (cement restrictor), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its type of evaluation.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" does not apply.

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

• Not applicable in the typical sense. For a physical device like this, "ground truth" would be established by engineering specifications, material properties, and observed mechanical performance under simulated load or surgical scenarios. The document states "conformance to product specifications" and "successful" function without further detail.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI model, so there is no "training set."

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

• Not applicable/Not provided. As there is no AI model, there is no training set or ground truth for it.

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