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The IN:C2 Spinal Fixation System 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 intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be used during spinal fusion. IN:C2 serves to stabilize the spine while bony fusion develops.

The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations, heights and lordosis angles. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.

The anterior cover plate assembly attaches to the anterior most portion of the device. and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.

The provided text describes a 510(k) premarket notification for the SpineSmith IN:C2 Spinal Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through mechanical testing, rather than reporting on a clinical study or AI-driven performance. Therefore, many of the requested elements are not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The submission relies on mechanical (non-clinical) testing, not clinical data or a test set in the context of an AI model.

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

Not applicable. This is a medical device clearance based on mechanical testing and substantial equivalence, not a study involving expert consensus for ground truth on patient data.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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 submission concerns a physical medical device (spinal fixation system) and does not involve AI or human readers evaluating images.

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

Not applicable. This submission does not involve an algorithm or AI.

7. The type of ground truth used

For the mechanical testing, the "ground truth" or acceptance criteria are the standards set by the relevant ASTM test methods (e.g., specific load resistance, deformation limits). The device's performance compared to these predefined engineering standards establishes its suitability.

8. The sample size for the training set

Not applicable. There is no AI model, and therefore no training set.

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

Not applicable. There is no AI model, and therefore no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The SpineSmith IN:C2 Spinal Fixation System demonstrated its compliance with acceptance criteria through a series of non-clinical mechanical tests. These tests were conducted according to established ASTM (American Society for Testing and Materials) standards relevant to intervertebral body fusion devices. The specific standards cited are:

• ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
• Draft Document Submitted to ASTM F-04.25.02.02: Static Pushout Test Method for Intervertebral Body Fusion Devices
• ASTM F1877-05: Standard Practice for Characterization of Particles

The conclusion drawn from these tests was that "any minor differences [between the subject device and predicate devices] do not impact device performance as compared to the predicates." This indicates that the SpineSmith IN:C2 system performed comparably to, and met the safety and performance expectations set by, its predicate devices when subjected to these standardized mechanical stresses. The FDA's 510(k) clearance is based on this demonstration of substantial equivalence through mechanical testing, rather than clinical efficacy studies. The "acceptance criteria" were therefore the performance benchmarks inherent in these ASTM standards and the performance of the legally marketed predicate devices.

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The VisuALIF 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 autograft to facilitate fusion.

The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. 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 Challenging Access System an extension to the VisuALIF System and both are part of the Cynch Spinal System. It is available in various sizes to accommodate individual patient anatomy. The VisuALIF Challenging Access implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. VisuALIF Challenging Access is intended to be used with the two (2) or more bone screws provided with the accompanying anterior cover plate assembly. 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 provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

This document describes the SpineSmith Cynch Spinal System – VisuALIF Interbody Fusion Implant System. The submission is for an extension to an already cleared device and demonstrates substantial equivalence to a predicate device (VisuALIF System, K102090). Substantial equivalence is the primary acceptance criterion for 510(k) clearances.

Here's an analysis based on the information provided, reinterpreting "acceptance criteria" in the context of a 510(k) submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

• Titanium alloy screws/cover plate assembly per ASTM F-136.
  These are the same as used in the predicate device. |
  | Design Characteristics (similar to predicate) | - 'U' shaped implant design to allow for placement of autograft bone.
• The primary change is the addition of additional screw holes and positions to the existing VisuALIF System to provide surgeons with additional surgical approach options, which is considered a minor difference. |
  | Biocompatibility | Implied as the materials are the same as the predicate and commonly used in implants. (Not explicitly stated as a separate test in this summary, but assumed for existing materials.) |
  | Mechanical Performance (equivalent to predicate) | - Static and dynamic compression testing (per ASTM F2077-03) conducted.
• Static and dynamic compression-shear testing (per ASTM F2077-03) conducted.
• Subsidence testing (per ASTM F2267-04) conducted.
• Expulsion testing (per ASTM Draft Standard F-04.25.02.02) conducted.
  Conclusion: "The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the VisuALIF Challenging Access System is substantially equivalent to the predicate device." |

2. Sample Size for Test Set and Data Provenance

• Test Set (for mechanical testing): The document does not specify exact sample sizes (number of implants tested) for the non-clinical mechanical tests (static, dynamic, subsidence, expulsion). Instead, it states that testing was "conducted in accordance with" specific ASTM standards. These standards typically define the number of samples required for such tests.
• Data Provenance: The data comes from non-clinical mechanical testing performed by the manufacturer, SpineSmith Partners, LP. It is not patient or human subject data.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for this spinal implant relates to its mechanical properties and equivalence to a predicate device, which is established through standardized engineering tests, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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

• Not applicable. This device is a physical spinal implant, not a diagnostic imaging device or AI-driven system that would involve human readers or image interpretation.

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

• Not applicable. This device is an implant, not an algorithm. Its "standalone performance" refers to its mechanical integrity, which was evaluated through the non-clinical tests mentioned.

7. Type of Ground Truth Used

• For the non-clinical mechanical testing, the "ground truth" is defined by the pass/fail criteria and methodologies outlined in the referenced ASTM standards (e.g., F2077-03, F2267-04, F-04.25.02.02 draft standard) for static and dynamic compression, compression-shear, subsidence, and expulsion. The results of the new device were compared against these standards and against the established performance of the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.

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

• Not applicable. See point 8.

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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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The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:

• Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis
• Spinal Stenosis
• Tumors
• . Trauma (i.e. fracture)

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

Acceptance Criteria and Device Performance Study for SpineSmith Cequence Anterior Cervical Plate System

The SpineSmith Cequence Anterior Cervical Plate System's acceptance criteria and performance are established through mechanical testing demonstrating substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document refers to "mechanical test results" in general, but does not specify the number of devices or iterations tested.
• Data Provenance: Not explicitly stated, however, the data would be generated in a laboratory setting as part of the device's design verification and validation. This is a prospective study in that tests are conducted on newly manufactured devices.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable. The ground truth for this device is established through objective mechanical testing against a predicate device, not through expert consensus on clinical cases.

4. Adjudication Method for Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., image interpretation), which is not relevant to mechanical testing.

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

• No. This is a medical device for spinal fixation, and its performance is evaluated through mechanical testing, not by human readers interpreting images. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical implant, not an algorithm. Its performance is inherent to its design and material properties demonstrated through mechanical testing.

7. Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The ground truth is based on established mechanical testing standards relevant to spinal implants and the performance characteristics of a legally marketed predicate device. This involves objective, quantifiable measurements.

8. Sample Size for Training Set

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

• . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• . Spondylolisthesis
• Spinal Stenosis .
• Tumors .
• Trauma (i.e. fracture) .

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

The provided document is a 510(k) Summary for the SpineSmith Cequence Anterior Cervical Plate System. This document describes a medical device, specifically a spinal implant, and its mechanical testing for substantial equivalence to a predicate device.

Here's an analysis of the document regarding acceptance criteria and a study proving the device meets them, based on the provided questions:

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)

The document mentions "Mechanical test results" but does not specify the sample size used for these mechanical tests. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) for a spinal implant, the "data" would likely refer to physical testing of components and assemblies.

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)

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing of a spinal implant is typically established by engineering standards and validated test methods, not by expert consensus in the medical field.

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

Not applicable. This is not a clinical study involving human assessment or a diagnostic 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

Not applicable. This is a spinal implant, not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This is a spinal implant, not an algorithm or AI system.

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

The ground truth for this device's performance is based on established mechanical engineering standards and validated test methodologies for spinal implants. The goal was to show "substantial equivalence" to a predicate device, meaning its mechanical properties and safety profile are comparable.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant.

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

Not applicable. There is no "training set" for this type of device and study.

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The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

When used as an intervertebral body fusion device, the Cimplicity System 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-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.

Cimplicity is a rectangular shaped implant, which is available in a parallel or lordotic configuration of various heights. Cimplicity is hollow to allow for the placement of allograft or autograft bone. There vare teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SpineSmith Cimplicity Spinal System:

Based on the provided text (K080971), this submission is for a traditional 510(k) premarket notification for a Class II medical device, specifically a Spinal Intervertebral Body Fixation Orthosis and an Intervertebral fusion device. For such devices, "acceptance criteria" and substantiating "studies" in the context of device performance are typically demonstrated through substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed predicate device.

The study presented here is primarily a mechanical test study comparing the proposed device to predicate devices, rather than a clinical study evaluating human performance or an AI algorithm's diagnostic capabilities. Therefore, many of the requested categories regarding AI, expert ground truth, and human reader performance are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details

Given that this is a 510(k) for a spinal implant, the "study" referred to is primarily a non-clinical, benchtop mechanical testing study to demonstrate substantial equivalence, not a clinical trial or AI performance study.

1. Sample size used for the test set and the data provenance:
   This information is not provided in the document. For mechanical testing, this would typically refer to the number of devices tested for each parameter (e.g., compression, torsion, fatigue). Data provenance is also not mentioned, but it would be from internal lab testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable for a mechanical testing study. Ground truth in this context would refer to physical measurements and engineering standards, not expert medical consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This is not applicable for a mechanical testing study. Mechanical test results are typically objective measurements against predefined criteria or comparison to predicate device performance.

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:
   No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For mechanical testing, the "ground truth" implicitly refers to engineering specifications, material properties, and performance benchmarks derived from predicate devices, established standards (e.g., ASTM, ISO), and biomechanical principles. It is based on objective physical measurements.

7. The sample size for the training set:
   Not applicable as this is not an AI/machine learning study.

8. How the ground truth for the training set was established:
   Not applicable as this is not an AI/machine learning study.

Summary regarding the device and its "study":

The SpineSmith Cimplicity Spinal System is a physical medical implant. Its safety and effectiveness are established through demonstrating substantial equivalence to existing predicate devices, primarily through mechanical testing. The document explicitly states: "Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device." This is the core "study" proving the device meets its (implied) acceptance criteria, which is to perform mechanically as well as or better than the predicate devices and to meet relevant engineering standards for spinal implants. The document does not contain details about the specific tests performed, the number of samples, or the quantitative results, only the conclusion of substantial equivalence.

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The Cimplicity Spinal Fixation System 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 intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cimplicity system is a rectangular interbody fusion device. The device is hollow and may be filled with graft material. Various sizes are provided to accommodate patient anatomy. Cimplicity is made from PEEK and has tantalum beads used for radiographic visualization.

This is a 510(k) premarket notification for an interbody fusion device, not a self-calibrating diagnostic device with acceptance criteria that would typically be evaluated through a clinical study with detailed performance metrics. The information provided describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on mechanical properties and material composition rather than diagnostic performance.

Therefore, many of the requested categories are not applicable to this type of submission. I will address the relevant points based on the provided text.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the context of this 510(k) submission for an interbody fusion device. The acceptance criteria for such a device primarily revolve around demonstrating substantial equivalence to a predicate device in terms of:

• Intended Use: The Cimplicity system's intended use is for anterior cervical interbody fusion procedures, which is consistent with the predicate.
• Mechanical Properties: The submission states that the Cimplicity Spinal System was tested and compared to predicate devices for mechanical properties. While specific numerical acceptance criteria and reported performance metrics are not detailed in this summary, the FDA's clearance implies these tests were satisfactory.
• Material Composition: Cimplicity is made from PEEK and has tantalum beads, which again, was found to be substantially equivalent to predicate devices.

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

This is not applicable in the context of a clinical performance study for an AI/diagnostic device. The "test set" for this device would refer to the mechanical and material testing conducted. The document does not specify the sample size for these engineering tests or the origin of any "data" in a diagnostic sense.

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

This is not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic performance studies. For an interbody fusion device, the "ground truth" relates to engineering standards and biocompatibility, which are assessed through laboratory testing and material analysis, not expert consensus on medical images or patient outcomes in a study setup.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies among expert readers.

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

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic algorithms or imaging techniques and how they impact human reader performance. This submission is for an implantable medical device.

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

This is not applicable. This refers to the standalone performance of an AI algorithm, which is not relevant for an interbody fusion device.

7. Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence determination would be based on:

• Engineering Test Standards: Mechanical properties (e.g., strength, fatigue) compared against established standards for spinal implants and/or predicate devices.
• Material Specifications: Verification that the PEEK material meets biocompatibility standards and that the tantalum markers are appropriate for radiographic visualization.
• Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices.

8. Sample Size for the Training Set

This is not applicable. "Training set" is a term used in machine learning for AI algorithm development. This 510(k) is not for an AI device.

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

This is not applicable for the same reasons as point 8.

Summary of the Study (as described in the 510(k) Summary):

The "study" undertaken for the Cimplicity Spinal Fixation System was a substantial equivalence comparison to predicate devices. The submission states:

• "The Cimplicity Spinal System was tested and compared to predicate devices and found to be substantially equivalent in terms of intended use, mechanical properties and material composition."

This indicates that engineering and material testing were performed to demonstrate that the Cimplicity device performs as safely and effectively as existing legally marketed devices, primarily the Affinity Cervical Cage (P000028) and others. The focus of this type of submission is to ensure that the new device does not raise new questions of safety or effectiveness.

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