Search Results

The Blustone Synergy Diamond SA Cervical System are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy Diamond SA Cervical System may be used with additional supplemental fixation.

The BluStone Synergy Diamond Stand Alone (SA) Cervical System consists of the Diamond cervical interbody plate and screws to be used in conjunction with the Blustone Synergy Interbody Fusion SLATE cervical interbody fusion devices to form the Diamond Stand Alone Cervical System. The Diamond Stand Alone cervical system is designed to be used with allograft and/or autograft. Use of the Diamond SA Cervical System is intended to expedite the Anterior Cervical Device instrumentation procedure, while minimizing tissue disruption through a minimally invasive approach. The Diamond plate includes anterior nail spikes to resist rotation and two holes for insertion of the included bone screws as well as an integrated locking plate to resist bone screw backout. The Diamond cervical interbody plate and screws are manufactured from titanium alloy. Previously cleared SLATE cervical cages to be used with the Diamond plate and screws are manufactured from PEEK and include tantalum markers. All implant components are available in various sizes to accommodate varying patient anatomy.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document is an FDA 510(k) clearance letter for a medical device called the "Blustone Synergy Diamond SA Cervical System," which is an intervertebral body fusion device.

The "Performance Testing" section mentions bench performance testing conducted on the device, including:

• Static and dynamic axial compression
• Static and dynamic axial compression shear
• Static and dynamic torsion per ASTM F2077-18
• Subsidence per ASTM F2267-04 (2018)
• Expulsion

It states that "Testing shows that the subject Blustone Synergy Diamond SA Cervical System performs equivalent to or better than the 5th percentile of FDA benchmark values." This implies there are FDA benchmark values that serve as acceptance criteria for mechanical performance.

However, the document does not discuss AI/ML device performance, acceptance criteria, or studies related to AI/ML device evaluation. It primarily focuses on the substantial equivalence of a physical surgical implant based on mechanical engineering tests.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Ask a specific question about this device

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

The Pro-Link 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 Cervical Spacer System is intended to serve as a stand-alone intervertebral body fusion device. The system is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. The implant is hollow to permit packing with autogenous bone graft to help promote fusion. It includes two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) to provide internal fixation while a titanium lock plate (Ti 6Al-4V ELI) prevents screw back out.

The provided document is a 510(k) summary for the Pro-Link Cervical Spacer System, a medical device for spinal fusion. It focuses on demonstrating substantial equivalence to previously cleared devices rather than direct clinical performance studies against specific acceptance criteria. Therefore, several of the requested sections are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the context of clinical outcomes or diagnostic accuracy. Instead, it demonstrates "substantial equivalence" to predicate devices through technical characteristics and a specific type of performance testing related to the device's physical properties.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often done through performance testing (like the mechanical testing mentioned) that shows the new device meets established standards or performs comparably to the predicate, and by showing similar materials, design, and intended use. Specific quantitative clinical performance metrics with pre-defined thresholds (e.g., sensitivity/specificity for a diagnostic device) are typically not included in this type of submission for an intervertebral body fusion device unless a new indication or technology is being introduced that requires clinical trials.

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

• Sample Size for Test Set: Not applicable / Not mentioned. The document describes mechanical testing of the device itself, not a clinical study with a "test set" of patients or data. The testing mentioned (ASTM F2077) would involve a sample of the manufactured devices. The specific number of devices tested is not provided.
• Data Provenance: Not applicable. The "performance data" refers to in-vitro mechanical testing of the device. There is no mention of country of origin for clinical data, as no clinical data from patients is referenced. The testing type is in-vitro, not retrospective or prospective clinical data.

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

Not applicable. This device is an intervertebral body fusion system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance data" section focuses on mechanical testing, which would be evaluated by engineers and regulatory bodies based on compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is relevant to the mechanical testing 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

Not applicable. This device is a surgical implant, not an AI-assisted diagnostic or decision support tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

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

7. The Type of Ground Truth Used

• For Mechanical Testing: The "ground truth" for the mechanical performance testing lies in the established ASTM standards (ASTM F2077, ASTM F2026, ASTM F560, ASTM F136). The device's performance is compared against these engineering standards and to the performance of predicate devices to establish substantial equivalence.
• For Substantial Equivalence: The ultimate "ground truth" for a 510(k) is the legal determination by the FDA that the new device is as safe and effective as a predicate device already on the market. This is a regulatory "truth" based on the submitted evidence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

Not applicable. This device does not involve a training set.

Ask a specific question about this device

The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.

The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation.

The acceptance criteria for the Cervical Standalone Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to a predicate device, the COALITION™ Spacer Intervertebral Body Fusion Device (K083389). The study proving the device meets these criteria involved mechanical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or
  clinical samples. The testing described is primarily mechanical and wear testing of the device itself.
• Data Provenance: Not applicable as the testing is non-clinical, mechanical testing of the device.

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

• Not applicable. The ground truth for this device's acceptance is based on adherence to engineering standards (ASTM F-2077 and F-2267) and comparison to a predicate device, not on expert clinical review of test data.

4. Adjudication method for the test set

• Not applicable. This was a non-clinical, mechanical testing study against established ASTM standards and
  predicate device equivalence.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a
  physical implant, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a physical implant, not an algorithm. The "standalone" in the device name refers to its design as an intervertebral fusion device that does not require an anterior plate.

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

• For the mechanical testing, the ground truth was defined by established engineering standards (ASTM F-2077 and F-2267) and the performance specifications of the device itself, with the aim of demonstrating that the device performed "as designed" and met/exceeded these specifications.
• For substantial equivalence, the ground truth was based on the characteristics and performance of the legally marketed predicate device (K083389).

8. The sample size for the training set

• Not applicable. This is a physical medical device undergoing mechanical validation, not a machine
  learning model requiring a training set.

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

• Not applicable, as there was no training set for a machine learning model.

Ask a specific question about this device