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Talos® Intervertebral Body Fusion Devices:

The Talos® IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos® IBF Devices are intended to be used with autograft comprised of cancellous and/or corticocancellous bone graft.

The Talos® IBF Device is to be used in patients who have had six months of non-operative treatment. Talos® IBF devices are to be implanted via a direct posterior, transforaminal, lateral, or anterior approach in the lumbosacral spine. The Talos®-A, Talos®-L, Talos®-T are intended to be used with supplemental fixation.

Talos®-C Cervical Intervertebral Body Fusion Devices:

The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in sketally mature patients with Degenerative Disc (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices:

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Non-operative treatment prior to treatment with Talos@-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.

The Talos® IBF Device is made of polymer, polyetheretherketone (PEEK). The Talos® IBF Device is available in four configurations: Talos®-P, Talos®-L, and Talos®-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® –P and Talos® –L are rectangular devices and the Talos® – A have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allow the Talos® IBF radiological confirmation for proper positioning.

The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.

The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

This document is a 510(k) premarket notification for Meditech Spine, LLC's Talos® Intervertebral Body Fusion Devices. It focuses on changes to previously cleared devices, specifically the addition of allograft bone options and a change in marker material for cervical devices.

Based on the provided text, the device itself (hardware) has not undergone changes, but the submission is for modifications to the indications for use concerning bone graft material and material change for radiopaque markers. Therefore, the acceptance criteria and study information relate to demonstrating that these proposed changes do not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to its predicate devices.

Here's the breakdown of the requested information based solely on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format for device performance (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly that the modified indications and marker material do not increase risk and maintain substantial equivalence to the predicate devices. The "reported device performance" is framed in terms of clinical outcomes from published literature for similar devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated as a specific number of patients or cases. The document refers to "Published retrospective clinical data" rather than a newly conducted study by the submitter.
• Data Provenance: "Published retrospective clinical data for lumbar and cervical intervertebral body fusion devices similar to the Talos® Intervertebral Body Fusion Devices..." No specific country of origin is mentioned.

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

This information is not provided in the document. As the clinical data referenced is "published retrospective clinical data," details about expert review for ground truth within those studies would not typically be part of this 510(k) summary.

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

This information is not provided in the document, as it refers to existing published literature rather than a new study with a specific adjudication protocol.

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 done? No. This document is for intervertebral body fusion devices, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.
• Effect size of human reader improvement with AI? Not applicable.

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

• Standalone study done? No. This document is for intervertebral body fusion devices, not a standalone AI algorithm.

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

The document references "published clinical outcomes" for similar devices. This implies that the "ground truth" for the effectiveness of allograft in fusion procedures would be based on clinical outcomes data (e.g., fusion rates, patient reported outcomes, absence of complications) from those retrospective studies.

8. The sample size for the training set

The concept of a "training set" is not applicable here as this is not an AI/ML device being developed or validated. The document refers to existing published clinical literature.

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

Not applicable, as this is not an AI/ML device, and no "training set" in that context is referenced. The "ground truth" in the context of the referenced clinical literature would have been established through standard clinical follow-up and evaluation methods of the respective studies.

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Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.

Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.

The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

The provided document is a 510(k) summary for a medical device called Talos®-C (HA) Cervical Intervertebral Body Fusion Devices. This type of regulatory filing demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed results for sensitivity, specificity, and other performance metrics typically associated with AI/software devices.

Therefore, the requested information elements related to AI device performance are not applicable and cannot be extracted from this document. This document focuses on the mechanical and material equivalence to a predicate device, as well as the indications for use.

Here's an analysis based on the information available:

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

The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or AUC as one would expect for an AI device. Instead, the acceptance criteria for this 510(k) submission are implied to be the successful demonstration of substantial equivalence to the predicate device, particularly in terms of mechanical function and properties.

The reported device performance is that the Talos®-C (HA) Cervical IBF Devices are equal in mechanical function and properties to the predicate device, thereby establishing equivalency in safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical mechanical testing of physical devices (implants), not a study involving patient data. Therefore, the concept of "sample size for the test set" in the context of patient data, data provenance, retrospective/prospective study, or country of origin is not applicable. The "test set" here refers to the physical devices manufactured and tested. The document does not specify the number of individual implants tested in each mechanical test, but it refers to standard ASTM methods, which typically involve a specified number of samples for statistical validity.

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 is not applicable. The ground truth for mechanical testing is established by the physical measurements and standards defined in the ASTM test methods, not by expert human interpretation of data like in medical imaging.

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

This is not applicable as it pertains to human interpretation of data, which is not what this document describes.

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

This is not applicable. This submission is for mechanical spinal implants, not an AI device or software that assists human readers.

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

This is not applicable. This is not an algorithm or AI device.

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 engineering standards and physical measurements from mechanical testing (e.g., force, displacement, cycles to failure) as defined by ASTM 2077 and ASTM 2267.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set.

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

This is not applicable. The device is not an AI or machine learning model.

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