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The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, 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 or retrolisthesis at the involved level(s). 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 Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: Lumbar interbody fusion device(s), which may be implanted bi-laterally via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach - as a single device via an anterior (ALIF) approach; or The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

The Helena System is an intervertebral body fusion device made of PEEK Optima LT1 with tantalum markers, designed for lumbar spine fusion from L2 to S1.

1. Acceptance Criteria and Device Performance

The acceptance criteria for the Helena System are based on non-clinical mechanical testing standards, demonstrating substantial equivalence to predicate devices. The device performance, as reported, met these criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided documents. The testing was non-clinical, involving mechanical tests of the device itself rather than patient data.
• Data Provenance: The data is based on laboratory non-clinical testing of the Helena System implants, following specified ASTM standards. No human or animal data provenance (e.g., country of origin, retrospective/prospective) is applicable to this type of testing.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The ground truth for the non-clinical mechanical tests is based on the performance standards defined by ASTM (American Society for Testing and Materials) specifications, not expert interpretation of medical images or patient data.

4. Adjudication Method for the Test Set

Not applicable. As the testing involved mechanical measurements against predefined standards, there was no need for expert adjudication. The results are quantitative and objective.

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

No MRMC study was performed or mentioned. This type of study is relevant for imaging-based diagnostic or prognostic AI tools that involve human interpretation, not for mechanical orthopedic implants.

6. Standalone Performance Study

A standalone performance study was done in the sense that the device's mechanical properties were tested independently against established standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The "algorithm only" concept is not applicable here as it's a physical medical device. The tests evaluated the device's ability to withstand various forces encountered in the body.

7. Type of Ground Truth Used

The ground truth used was objective engineering standards and performance criteria as defined by the ASTM standards (ASTM F2077-03 for static and dynamic compression, ASTM F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion).

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device like this. Machine learning algorithms require training sets, but this regulatory submission concerns a physical implant.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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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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