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TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages is to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Tryptik® Ti is an anterior cervical interbody fusion device intended to provide mechanical support to the cervical spine and maintain adequate disc space until fusion occurs. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Tryptik® Ti spacers are all made from medical grade titanium alloy and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The Tryptik® Ti interbody spacer has a monolithic design that incorporates solid and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant. The Tryptik® Ti spacers are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

This information is not contained in the provided document. The document is a 510(k) summary for a medical device (TRYPTIK®Ti Anterior Cervical Intervertebral Fusion Devices) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of mechanical properties. It does not describe a study involving patient data, expert review, or AI performance.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (in terms of clinical outcomes or AI metrics).
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or AI improvement effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data, etc.) for a clinical study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document only states that "Results demonstrate comparable mechanical properties to the identified predicate devices" based on non-clinical tests (Static and Dynamic Axial Compression, Static and Dynamic Shear-compression, Static and Dynamic Torsion according to ASTM F2077-18 and Subsidence according to ASTM F2267-04). It also mentions "Additionally, cadaver lab implantation trials were conducted." However, no specific performance metrics or acceptance criteria for these tests are provided in the summary.

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The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.

The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, 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 FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The FAVO S-TLIF (straight transforaminal lumbar interbody fusion) Cage is an implant for primary stabilization and restoration of physiological lordosis in the lumbar and thoracic spine. The cage is designed for transforaminal approaches.

The aim is to eliminate discogenic back pain, correct deformities, remedy instabilities, restore intervertebral height, restore physiological lordosis, and provide biomechanical support for bone fusion in the disc space.

The system is designed for use with autogenous bone graft to facilitate fusion and must be used with additional stabilization. For posterior lumbar stabilization, Silony Medical recommends the use of a posterior spinal fixator (e.g., the VERTICALE system). The devices are to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF is manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and ASTM F3001.

The FAVO S-TLIF implant is delivered in a sterile condition and can be used without any further preparations. The cages are packaged in accordance with EN ISO 11607 Party 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.

Implants delivered by the manufacturer in a sterile condition may not be sterilized.

This document is a 510(k) Premarket Notification for a medical device called FAVO® S-TLIF, which is an intervertebral body fusion device. The document does not describe a study that uses AI or machine learning technology, so the request for acceptance criteria and study details related to an AI device cannot be fulfilled from this document.

The provided text describes the regulatory clearance of a physical medical device (intervertebral body fusion cage) and outlines its indications for use, device description, and non-clinical performance data (mechanical testing, biocompatibility, sterilization, shelf life, and transport testing). It explicitly states that no human clinical testing was required because the indications for use are equivalent to a predicate device and non-clinical testing supports substantial equivalence.

Therefore, since the request pertains to an AI device and this document is about a physical spinal implant with no mention of AI or machine learning, I cannot extract the requested information.

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The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.

This document is a 510(k) summary for the Oyster ACIF Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical testing, rather than an AI/ML-driven device that would involve a test set, ground truth, and human reader performance studies.

Therefore, many of the requested criteria for an AI/ML device, such as acceptance criteria based on metrics like sensitivity/specificity, sample size for AI test sets, expert adjudication methods, MRMC studies, and training set information, are not applicable to this submission.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria in the traditional sense for an AI/ML device (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it focuses on mechanical performance data comparing the device's strength to predicate devices. The acceptance criteria are implicitly that the mechanical test results are "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

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

This information is not applicable as the device is a spinal implant, not an AI/ML diagnostic tool. The "testing" refers to mechanical and material property tests on the device itself, not a clinical test set of 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)

This is not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels for medical data, typically established by clinical experts. For a spinal implant, "ground truth" relates to the physical and biological performance of the material and design, established through engineering standards and biological compatibility assessments.

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

This is not applicable. Adjudication methods are used in clinical studies involving interpretation of medical images or data by human experts for ground truth establishment.

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. MRMC studies are used to evaluate the impact of AI on human reader performance in diagnostic tasks. This device is a physical implant.

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

This is not applicable. Standalone performance is a concept for AI algorithms.

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

For this device, the "ground truth" to which its performance is compared is based on established engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. It's a "truth" derived from physical and mechanical testing, not clinical diagnosis.

8. The sample size for the training set

This is not applicable. This refers to AI/ML model training, which is not relevant for this medical device.

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

This is not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant). The acceptance criteria and performance data discussed are related to the device's mechanical and material properties, rather than its performance as an AI/ML diagnostic tool. Therefore, many of the questions asked, which are specific to AI/ML device evaluation, are not relevant to this submission.

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