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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 Scarlet® AL-T system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.

When used as a lumbar intervertebral fi.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device with integrated fixation intended to provide mechanical support to the lumbar spine and maintain adequate disc space until fusion occurs. The Scarlet® AL-T system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Scarlet® AL-T 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 Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice 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.
When used as a stand-alone system with its integrated fixation, the spacer is crossed by three (3) bone screws protruding into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that prevent backing out.
The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).

The provided text describes the Scarlet® AL-T intervertebral body fusion device and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the mechanical and material testing for a physical medical device (intervertebral body fusion device) to demonstrate its substantial equivalence to previously cleared devices under a 510(k) premarket notification. The tests mentioned are:

• Static and dynamic axial compression (per ASTM F2077-17)
• Static and dynamic Shear compression (per ASTM F2077-17)
• Expulsion (per ASTM Draft F-04.25.02.02)
• Subsidence (per ASTM F2267-04)
• Bacterial endotoxin testing (per USP standard)

The conclusion states that these non-clinical tests demonstrate comparable mechanical properties to the predicate devices and that the Scarlet® AL-T has demonstrated substantial equivalence based on design, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing.

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JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, implanted via a lateral approach, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The Juliet® Ti LL spinal implants are additively manufactured and present both solid and porous structures. the The subject implants Juliet® Ti LL will extend the previously cleared Juliet® Ti (PO, OL & TL) range of implants (K153621) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM) and will join the previously cleared Juliet® LL range of implants (K161888; K141135) which presents similar design features and addresses the same surgical approach and utilize the same instrumentation designed purposely. The Juliet® Ti LL 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 Juliet® Ti LL, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting a study proving performance against acceptance criteria for a new AI/CAD device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, MRMC studies, effect size, standalone performance, ground truth establishment) are not applicable to this type of submission. This document describes a medical implant, not an AI software.

Here's the information that can be extracted from the provided text, primarily focusing on the device's characteristics and the testing mentioned for ensuring its safety and effectiveness (as part of establishing substantial equivalence to predicates):

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an implant and not an AI/CAD software, there isn't a direct "acceptance criteria" table in the sense of performance metrics for an algorithm. Instead, the document describes the device and then lists the non-clinical tests performed to demonstrate its safety and effectiveness, primarily by showing it meets established standards comparable to its predicate devices. These standards effectively serve as the "acceptance criteria" for this type of device.

Additional Requested Information:

1. Sample size used for the test set and the data provenance:

   • N/A. This is not an AI/CAD device, so there is no "test set" of patient data in this context. The testing mentioned refers to physical, mechanical, and material testing of the device itself.
   • For the physical device testing, the sample sizes would typically be small, determined by engineering statistical methods for material and mechanical verification (e.g., n=3 or n=5 for specific physical tests), but these are not explicitly stated in this summary.

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

   • N/A. No expert ground truth establishment for a patient data test set.

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

   • N/A. No adjudication method for a patient data test set.

4. 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:

   • N/A. This is not an AI-assisted device.

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

   • N/A. This is not an AI algorithm.

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

   • N/A. For this device, "ground truth" relates to compliance with established material standards (e.g., ASTM standards for titanium alloy properties) and biomechanical test methods (e.g., ASTM F2077 for intervertebral body fusion device mechanical testing). The ground truth is engineering and materials science-based, not patient-data based in the context of diagnostic accuracy.

7. The sample size for the training set:

   • N/A. No training set as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • N/A. No training set.

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