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The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

The Visualif System is part of the Cynch Spinal System and is available in various sizes to accommodate individual patient anatomy. The Visualif implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. Visualif is a stand-alone device intended to be used with two (2) bone screws provided and the accompanying anterior cover plate assembly. NOTE: The cover plate assembly and screws are part of the implant construct.

Addition of an ALIF version to the existing Cynch System is intended to provide surgeons with additional surgical approach options. There are no changes with respect to indications or intended use as compared to the Cynch Spinal System cleared previously via K090376.

The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device. The subject device (Visualif - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376).

The provided text describes a medical device, the "SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System," and its clearance process. However, it does not contain information about acceptance criteria in the typical sense for evaluating device performance in a clinical study (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed to establish substantial equivalence to a predicate device.

The study presented is a non-clinical testing study conducted to demonstrate substantial equivalence, not a clinical trial evaluating human performance or AI effectiveness.

Here's an breakdown based on the information provided:

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

Since this is a non-clinical substantial equivalence study, the "acceptance criteria" are implied by the comparison to the predicate device's performance in mechanical tests. The reported device performance is that the subject device's results were "substantially equivalent" to the predicate.

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

• Sample Size: Not explicitly stated as a number of devices or tests. The document refers to "testing" being conducted in accordance with ASTM standards. For mechanical testing of medical devices, samples are typically tested until statistical significance is achieved or to meet the requirements of the specific ASTM standard. The exact number of samples (e.g., number of implants tested per condition) is not provided.
• Data Provenance: Not applicable in the context of geographical origin for mechanical testing. The testing was non-clinical (laboratory-based) as opposed to human or patient data.

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

• Number of Experts: Not applicable. This was a non-clinical, mechanical testing study comparing a device to a predicate based on standardized ASTM test methods. No human experts were involved in establishing "ground truth" in the way they would for, say, image interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no "ground truth" established by human experts requiring adjudication in this type of mechanical testing 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission concerns a physical medical implant (intervertebral fusion device) and involves non-clinical mechanical testing, not an AI-powered diagnostic or interpretive device.

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

• This question is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" in this context is the performance of the predicate device measured against established ASTM standards for mechanical properties. The goal was to show that the subject device's performance was "substantially equivalent" to that of the already cleared predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a non-clinical study for a physical implant, not an AI/machine learning device that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there was no training set for an AI/machine learning model.

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The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 SpineSmith Cynch System is offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach. The system consists of the Cynch TLIF device for transforaminal lumbar approach and the Cynch PLIF/T-PLIF device, which may be implanted via a posterior lumbar bi-lateral approach or transverse lumbar approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.

The Cynch System implants are hollow to allow for the placement of autograft bone, and have large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the implants to provide increased stability and inhibit movement of the implant. The implants have horizontal grooves to locate the implant holder superior/inferior and rotationally. Additionally, a cross-bar is provided to minimize buckling during insertion.

The provided document describes the SpineSmith Cynch Spinal System, an intervertebral body fusion device. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are defined by the referenced ASTM standards, which specify methods and requirements for evaluating the mechanical properties of intervertebral body fusion devices. The reported "device performance" indicates that the SpineSmith Cynch Spinal System achieved "substantially equivalent results" when tested according to these standards, meaning its mechanical performance was comparable to the predicate devices which have already been deemed safe and effective.

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

• Sample Size: Not explicitly stated. The document mentions "non-clinical tests" and "results" but does not quantify the number of units tested for each mechanical assessment.
• Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). These are non-clinical mechanical tests conducted in a laboratory setting.

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

• Not Applicable. This is a mechanical device, and "ground truth" for its performance is established through adherence to standardized engineering tests (ASTM standards) rather than expert consensus on clinical interpretation or outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, the "test set" refers to mechanical properties evaluated against engineering standards. There is no human adjudication process involved in interpreting these test results beyond ensuring adherence to test protocols and data analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a mechanical device, and an MRMC study is relevant for evaluating diagnostic or imaging devices where human readers interpret medical images. This document describes non-clinical mechanical tests.

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

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The "ground truth" for demonstrating the safety and effectiveness of the Cynch System is its ability to perform equivalently to predicate devices when subjected to established mechanical testing standards (ASTM F2077-03, ASTM F2267-04, ASTM Draft Standard F-04.25.02.02).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no training set in this context.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Cynch System is indicated intervertebral body fusion of the lumbar spine, from L2 to SI, 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.

Cynch is curved to allow for medial-lateral placement of the device, and is available in two footprints (25mm and 30mm) with a 5° lordosis in various heights. Cynch is hollow to allow for the placement of autograft bone, and has large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

This 510(k) summary describes a spinal implant device and focuses on establishing substantial equivalence for market clearance, rather than presenting a study with specific acceptance criteria related to device performance in a clinical context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not describe a clinical "test set" in the context of human subjects or a dataset for evaluating an AI/software device. The primary evaluation is mechanical testing and comparison to predicate devices. Therefore, these categories are not applicable.

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

Not applicable, as there is no mention of a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable.

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

No. This is not an AI/software device, and no human-reader study is mentioned.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Not applicable, as this is a physical medical device (spinal implant), not a software or AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance and safety profile of legally marketed predicate devices. The Cynch Spinal System aims to demonstrate equivalence to these established devices through mechanical testing and design comparison.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/software device that undergoes a "training set" process.

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

Not applicable. The "ground truth" for comparison is based on the previously cleared predicate devices and their compliance with FDA regulations.

Summary of the Study and Acceptance Criteria:

The "study" described in the provided text is a 510(k) premarket notification aiming to demonstrate substantial equivalence to legally marketed predicate devices.

• Acceptance Criteria: The primary acceptance criterion is substantial equivalence to the identified predicate devices (LT-CAGE®, BAK® Cage, RAY® Threaded Fusion Cage, Lumbar I/F Cage). This means the device must be as safe and effective as a legally marketed device. This equivalence is primarily assessed through:

  • Mechanical Test Data: The device must perform comparably in mechanical testing to the predicate devices. The text states: "Mechanical test results demonstrate that the Cynch System is substantially equivalent to the predicate."
  • Indications for Use: The device's intended use must be the same as or comparable to the predicate devices. The indications provided are consistent with those typically found in lumbar intervertebral fusion devices.
  • Technological Characteristics: The design, materials, and operational principles must be sufficiently similar to the predicate devices. The device description details aspects like its curvature, footprints, lordosis, hollowness for autograft, graft windows, and teeth for stability, implying comparison to similar features in predicates.

• Study That Proves the Device Meets Acceptance Criteria:
  The study that proves the device meets the acceptance criteria is the set of mechanical tests performed on the Cynch System, along with a comparison of its design features and indications for use against the predicate devices. The 510(k) submission itself is the document that presents this evidence to the FDA. The FDA's issuance of the 510(k) clearance signifies their agreement that substantial equivalence has been demonstrated. The provided text, however, does not include the detailed results or methodology of these mechanical tests, only the summary statement that they demonstrate substantial equivalence.

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