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The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Pro-Link® Ti Barbs Cervical Spacer System is to be used with autogenous bone graft and implanted via an anterior approach.

The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an interbody fusion device intended to be used with two (2) titanium bone barbs. The Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screw).

The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is offered in various device configurations based on surgical approach and patient anatomy. The Pro-Link® Ti Barbs Cervical Spacer System includes an interbody, containing a titanium alloy locking mechanism, which is implanted with two (2) titanium bone barbs. The interbody is offered in either PEEK (Polyetheretherketone) or in titanium alloy (Ti 6Al-4V ELI). The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screws).

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System components with components from any other system or manufacturer. The Pro-Link® Ti Barbs Cervical Spacer System components should never be reused under any circumstances.

I apologize, but the provided text from the FDA 510(k) clearance letter and related documents for the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System does not contain information about acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based medical devices (such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The document is a clearance letter for a traditional orthopedic implant (intervertebral body fusion device), not a software or AI-driven device. Therefore, it focuses on demonstrating substantial equivalence to predicate physical devices based on design, materials, indications for use, and performance, primarily through a comparison of physical and mechanical properties, not through clinical or reader studies that would generate the types of data you are asking for.

The relevant sections of your request (2 through 9) are specific to the evaluation of AI/ML software devices, which are not applicable to the information provided in this document.

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The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.

The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.

The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6A1-4V ELI) to prevent screw back out.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link Ti Stand-Alone Cervical Spacer System components with components from any other system or manufacturer. The PRO-LINK Ti Stand-Alone Cervical Spacer System components should never be reused under any circumstances.

The provided document, an FDA 510(k) premarket notification letter, describes the "Pro-Link® Ti Stand-Alone Cervical Spacer System." However, it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory clearance for a medical device (an intervertebral body fusion device), stating that it is substantially equivalent to legally marketed predicate devices. It focuses on:

• Device Name: Pro-Link® Ti Stand-Alone Cervical Spacer System
• Regulation Information: Classification, product code, regulation number.
• Indications for Use: Spinal fusion in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1), used with provided screws and autogenous bone graft, after six weeks of non-operative treatment.
• Device Description: Material (titanium Ti 6Al-4V ELI), design features (hollow for bone graft, superior/inferior teeth, pockets for bone screws, threaded hole for lock plate).
• Technological Characteristics & Material: Stating substantial equivalence to predicates in design, materials, indications for use, and sizing. It specifically mentions the use of implant grade (Ti-6AL-4V) Titanium alloy according to F136, same as predicate devices.
• Performance Data: States that "Engineering rationales and FEA were provided to demonstrate the substantial equivalency." This refers to in silico (computational) analysis rather than clinical or human reader studies.
• Substantial Equivalence Conclusion: Confirms substantial equivalence based on indications for use, design, function, materials used, and mechanical performance.

Therefore, it is not possible to fill out the table or answer most of your detailed questions based on the provided text, as this type of information is typically found in the full 510(k) submission or associated test reports, which are not included here.

Here's what can be inferred or stated as "not applicable/not found" based on the document:

1. A table of acceptance criteria and the 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)

• Sample Size (Test Set): Not applicable. This document refers to engineering rationales and FEA (Finite Element Analysis) for substantial equivalence, not human clinical test sets.
• Data Provenance: Not applicable.

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. No human test set or ground truth establishment by experts is described for performance evaluation in this document.

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

• Not applicable. No human test set is described.

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 spinal implant, not an AI diagnostic device. MRMC studies are not relevant for this device type.

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

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

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

• Not applicable. The performance data mentioned refers to engineering rationales and Finite Element Analysis (FEA), typically comparing mechanical properties to established safety standards or predicate device specifications.

8. The sample size for the training set

• Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned. The device's design is based on engineering principles and comparison to predicate devices, not iterative training.

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

• Not applicable.

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The Pro-Link® Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.

The Pro-Link® Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of nonoperative treatment. This device is intended to be used with autogenous bone graft.

The Pro-Link® Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either Titanium (Ti 6Al-4V ELI) or Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers and titanium pins (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6Al-4V ELI) to prevent screw back out.

The provided text describes a medical device, the Pro-Link® Stand-Alone Cervical Spacer System, and its substantial equivalence to predicate devices, focusing on its design, materials, and intended use. However, it does not contain the detailed acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive FDA submission.

The "Performance Data" section briefly mentions "Mechanical testing" and "engineering rationale" conducted according to FDA guidance, but it does not provide specific acceptance criteria values, reported device performance metrics, or the actual study results. It only states that the testing was performed to demonstrate that no 'worst-case condition' was introduced.

Therefore, I cannot fulfill your request for the specific table and study details as they are not present in the provided text.

Here's what I can extract based on the information given, and where the requested information is missing:

Acceptance Criteria and Device Performance

Study Details:

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

   • Test set sample size: Not specified.
   • Data provenance: Mechanical testing and engineering rationale were performed according to FDA guidance and specific ISO standards (though the full standard name is garbled in the text). This implies laboratory testing rather than human subject data.

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

   • Not applicable as the reported "Performance Data" refers to mechanical testing, not clinical data requiring expert ground truth.

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

   • Not applicable for mechanical testing.

4. 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 device is a physical intervertebral body fusion device, not an AI or imaging diagnostic device.

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

   • Not applicable. This is a physical medical device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the mechanical performance, the "ground truth" would be established engineering principles and performance standards (e.g., ISO for intervertebral fusion devices).

7. The sample size for the training set:

   • Not applicable, as this is a physical device undergoing mechanical testing, not an AI algorithm requiring a training set.

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

   • Not applicable.

Summary of what the document does say about performance:

The document states:
"Mechanical testing and engineering rationale to compare compressive and static torsion conducted in accordance with '510(k) Guidance Document for Intervertebral Body Fusion Devices,' June 14, 2007, was presented to demonstrate that no 'worst-case condition' was introduced to the Pro-Link® Stand-Alone Cervical Spacer System."

This indicates that the "study" demonstrating performance was a series of mechanical tests (compressive and static torsion) and engineering analysis, rather than a clinical trial with human subjects. The purpose was to show that the new device did not introduce any "worst-case condition" compared to its predicate devices, thereby supporting the claim of substantial equivalence.

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