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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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The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

ELSA™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance.

ELSA™ Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with ELSA™ are manufactured from titanium allov, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The provided text describes a medical device, the ELSA™ Spacer, which is an intervertebral body fusion device. The document is a 510(k) premarket notification summary submitted to the FDA. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text does not include information about acceptance criteria for a device's performance (such as a diagnostic algorithm or AI system) or a study that specifically proves the device meets such criteria in terms of clinical accuracy or effectiveness. Instead, it describes mechanical and material performance testing for the physical implant itself, aimed at demonstrating functional equivalence to existing devices.

Therefore, many of the requested categories about acceptance criteria, clinical study design, ground truth establishment, and AI performance metrics cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document lists performance tests conducted for the physical device, not for a diagnostic algorithm's accuracy. The "acceptance criteria" here relate to the mechanical integrity and safety of the implant itself, aligning with established ASTM standards for intervertebral fusion devices.

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

• Not applicable. This document describes mechanical and material testing of a physical implant, not a clinical study involving a test set of patient data or images. The "samples" would refer to the number of devices subjected to various mechanical stress tests, which is not specified in this summary.

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. Ground truth establishment by clinical experts is relevant for diagnostic or AI devices, not for the mechanical testing of an interbody fusion device.

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

• Not applicable. This pertains to clinical studies for diagnostic accuracy, not mechanical testing.

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 for AI-assisted diagnostic devices. The ELSA™ Spacer is a physical implant.

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

• Not applicable. There is no algorithm or AI component described for the ELSA™ Spacer.

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM and FDA guidance) for device strength, durability, and biocompatibility.

8. The sample size for the training set

• Not applicable. There is no AI training set mentioned for this physical device.

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

• Not applicable. No training set or ground truth in the AI context are relevant to this document.

Summary of Device and Study Type:

The ELSA™ Spacer is an interbody fusion device, a physical implant used in spinal surgery. The "study" described in this document is a series of mechanical and material performance tests (e.g., static and dynamic compression, subsidence, expulsion, bacterial endotoxin) conducted in accordance with established ASTM standards and FDA guidance. The purpose of these tests is to demonstrate the substantial equivalence of the ELSA™ Spacer to legally marketed predicate devices in terms of safety, function, and mechanical integrity, rather than clinical diagnostic performance or AI accuracy.

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