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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 are 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 are 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.

Spineart Tryptik® Ti spinal implants consist in a range of intervertebral body spacers with various shapes and designs so as to be implanted via an anterior cervical approach and to adapt different patient's conditions. The Tryptik® Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The subject implants Tryptik® Ti will extend the previously cleared Tryptik® Ti range of implants (K200312) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM), and join the previously cleared Tryptik® Ti range of implants (K200312) which addresses the same indications and utilize the same instrumentation designed purposely. The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile).

This is a 510(k) premarket notification for a medical device called Tryptik® Ti, an intervertebral body fusion device. The document states that "No additional testing has been performed for the Spineart Tryptik® Ti line extension spinal implants." and relies on an "engineering rationale" to support substantial equivalence to a previously cleared version of the same device and other predicate devices.

Therefore, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states that no additional testing was performed for this particular submission.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Technological characteristics: The device uses the same manufacturing technology (additive manufacturing - SLM) and material (medical grade titanium alloy conforming to ASTM F136 and ASTM F3001) as the primary predicate device.
2. Design features: The device presents similar design features and range of devices, and is designed for the same anterior approach as the previously cleared Tryptik® Ti spinal implants.
3. Indications for use: The indications for use are identical to the predicate device.

The document also mentions that non-clinical tests (Static axial compression, Static shear compression, Static torsion according to ASTM F2077 and subsidence testing according to ASTM F2267) were conducted on the predicate devices, not this current submission.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established**

as this information is not present in the provided text. The submission relies on prior testing of predicate devices and an engineering rationale for substantial equivalence.

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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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