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The VIRTU Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthessis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the VIRTU Lumbar Spacer System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the VIRTU PLIF/TLIF System.

The VIRTU Lumbar Spacer System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The VIRTU Posterior Lumbar Spacer System consists of implants, trials and instruments. The VIRTU Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

This document describes a 510(k) premarket notification for the "VIRTU Lumbar Spacer System", a medical device. As such, it does not present independent clinical studies or acceptance criteria for AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices based on non-clinical performance data.

Therefore, many of the requested categories for AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to this submission.

However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them.

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

Based on the document, the acceptance criteria are implicitly tied to demonstrating performance "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device was tested against recognized ASTM standards. The reported device performance is that it met these standards and was found to be substantially equivalent.

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 does not specify the sample size for the mechanical tests. The data provenance is "non-clinical testing" conducted by the submitter (Met 1 Technologies, LLC). This is laboratory testing, not human patient data.

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. This is mechanical testing to established engineering standards, not human expert consensus. The "ground truth" is adherence to the specified ASTM testing methodologies and achieving results comparable to predicate devices.

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

Not applicable. This is mechanical testing, not a clinical trial with human disagreement.

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 device, not an AI diagnostic tool.

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

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

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

For the non-clinical performance data, the "ground truth" is adherence to established mechanical testing standards (ASTM standards) and the resultant data demonstrating the device's mechanical properties. The benchmark for "sufficient" is implied to be comparable performance to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Med-LIF is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers. The Cogent Med-LIF is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options, 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 10mm wide and are available in three lengths; 20, 25 and 30mm. The Cogent Med-LIF implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space. The Cogent Med-LIF implants are non-sterile and are to be sterilized by the end user.

The provided document describes the Cogent Med-LIF, an intervertebral body fusion device, and its performance testing for a 510(k) submission. It does not describe a study involving AI, software or an analytical device. Therefore, it is impossible to answer the following sections, as they are not presented in the document:

• Acceptance criteria and reported device performance related to a diagnostic or analytical AI/software device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the physical device's performance testing and its overall conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For the physical device, Cogent Med-LIF, the "acceptance criteria" are implied by compliance with ASTM standards and demonstrating performance comparable to legally marketed predicates. The "reported device performance" is a general statement that the device met these criteria.

Summary of the Study:

The document describes bench testing and a cadaveric implantation study for the Cogent Med-LIF device.

• Bench Tests: These tests focused on the mechanical properties of the device, adhering to established ASTM standards (F2077, F2267, and a draft expulsion standard). The specific acceptance criteria for these tests would be the performance benchmarks defined by these ASTM standards or comparative performance to the predicate devices.
• Cadaveric Implantation Study: This study's purpose was to confirm that autogenous bone graft could be adequately delivered using the Cogent Med-LIF, specifically when compared to a legally marketed predicate device.

Overall Conclusion:
The manufacturer concluded that "mechanical and non-clinical testing of the Cogent Med-LIF device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." This statement serves as the final "reported device performance" and meets the overarching "acceptance criteria" for a 510(k) submission, which is to demonstrate substantial equivalence to a predicate device.

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The Idys™ LIF Cages are indicated for use with autologous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by FDA for use in the lumbar spine.

The Idys™ LIF Cages consist of PEEK lumbar cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Idys™ LIF Cages also feature markers made of Tantalum according to ASTM F560.

The Idys™ LIF Cages have different anatomic shapes and dimensions based on the surgical approach: PLIF (posterior lumbar interbody fusion); TLIF (transforaminal lumbar interbody fusion); and PTLIF (posterior approach and oblique-TLIF approach).

The Idys™ PLIF Cage is a hollow spacer with openings for autograft on the top, bottom, and sides of the device.

the Idys™ TLIF Cage has a bullet tip to facilitate introduction. The TLIF Cage Holder instrument has a clamp that affixes to the axle to enable rotation of the device during its introduction in situ.

The Idys™ PTLIF Cage is inserted in an oblique position. It can be introduced with a PLIF approach or a TLIF approach to the convenience of the surgeon and with taking into account the profile of the patient.

The Idys™ LIF Cage procedures are performed using a set of surgical instruments common for PLIF and TLIF approaches. Most of the instruments provided are common surgical tools used in these types of interbody fusion procedures. Those instruments are considered Class I, general purpose, manual orthopedic instruments encompassed within the regulation in 21 CFR 888.4540.

This document describes the acceptance criteria and the study that proves the device meets those criteria for CLARIANCE's Idys™ LIF Cages.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each of the performance tests (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion, and wear testing). It only mentions that performance testing was conducted per ASTM F2077 and ASTM F2267.

The data provenance is not specified beyond indicating that the studies were performed by CLARIANCE, a French company. It does not state whether the data was retrospective or prospective.

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

For this type of device (intervertebral body fusion cages), the "ground truth" is typically established through recognized industry standards for mechanical performance rather than expert consensus on medical images or patient outcomes. The document indicates that performance testing was conducted per ASTM F2077 and ASTM F2267. These ASTM standards define the methodologies and acceptance criteria for mechanical testing of spinal intervertebral body fusion devices. Therefore, the "experts" in this context would be those who interpreted and conducted the tests according to these established standards. The document does not specify the number or qualifications of the individuals who performed or interpreted these tests.

4. Adjudication Method for the Test Set

Not applicable for a device performance study based on engineering standards. The performance is objectively measured against the criteria defined by ASTM F2077 and ASTM F2267, rather than requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI, not for mechanical devices like intervertebral body fusion cages.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only without human-in-the-loop performance) study was done. This concept is not applicable to an intervertebral body fusion device, which is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance was the mechanical performance standards specified in ASTM F2077 and ASTM F2267. This includes metrics like static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and wear.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI model that requires a training set. The term "training set" is typically used in the context of machine learning and artificial intelligence.

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

Not applicable, as there is no training set for this device.

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