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The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.

Interbody devices used with three fully threaded bone screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation. Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three fixation components (OLIF devices and 2-Hole ALIF devices) or used with anchors or impacted screws must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.

The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

The ProAM ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and fixation devices manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).

The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.

The fixation devices consist of Bone Screws, Impacted Screws, and Curved Anchors. Bone Screws are available in various diameters and lengths and engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone. Impacted Screws are available in various lengths. They are first impacted through the intervertebral body fusion device into bone and then turned to further fixate to the bone. Curved Anchors are available in various lengths and are impacted into the bone through the intervertebral body fusion device.

The purpose of this premarket notification is to add the Impacted Screws and Curved Anchors as fixation devices for the ProAM ALIF System

The provided FDA 510(k) clearance letter for the ProAM ALIF System does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices.

This document is a standard 510(k) clearance for an intervertebral body fusion device, which is a physical implant. The information provided focuses on material composition, mechanical testing (static and dynamic cantilever, expulsion), and substantial equivalence to predicate devices based on design, indications for use, and performance of the physical implant.

Therefore, I cannot answer the questions posed regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, or adjudication methods, as these are all relevant to the evaluation of AI/ML or software-driven medical devices, not a physical orthopedic implant like the ProAM ALIF System.

The questions are highly appropriate for an AI/ML medical device, but the provided text is a clearance letter for a mechanical implant.

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The ProAM ACDF System is a standalone intervertebral body fusion system intended for spinal fusion procedures of the cervical (C2-T1) spine in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI).

The ProAM ACDF System is intended to be used at multiple contiguous levels of the cervical spine (C2-T1). The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

The ProAM ACDF System is intended for use on patients who have had at least six weeks of nonoperative treatment. It is intended to be used with autogenous and/or allogeneic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft.

The ProAM™ ACDF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and screws manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).

The intervertebral body fusion device has a cross-sectional shape that is trapezoidal, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is meant for direct anterior insertion and has 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.

The screws are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.

The provided text describes a 510(k) premarket notification for a medical device called the ProAM ACDF System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data related to mechanical testing for orthopedic implants.

The document does NOT contain information related to software, human-in-the-loop performance, or AI assistance. Therefore, it is not possible to answer questions 2, 3, 4, 5, 8, and 9 as they pertain to such studies.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

The document broadly states that "The mechanical testing demonstrated that the device performs as well or better than the predicates." However, it does not provide specific numerical acceptance criteria or the reported performance values. The tests performed are listed as:

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "mechanical testing" but does not provide details on the number of samples used for each test.
• Data Provenance: The data is generated from in vitro mechanical testing of the device itself. The country of origin for the data is not explicitly stated, but the company is based in Carlsbad, CA, suggesting the testing was likely conducted in the US or by a US-affiliated lab. The testing is for prospective device performance evaluation based on design and manufacturing.

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

Not applicable. This question typically refers to studies involving human interpretation (e.g., image analysis by radiologists). The described study is mechanical testing of a physical implant, where ground truth is established by engineering standards (ASTM F2077, ASTM F2267) and test results.

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

Not applicable. See reasoning for question 3. Adjudication methods are typically used for subjectively assessed data, not objective mechanical tests.

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 study is a 510(k) submission for a physical intervertebral body fusion device and does not involve AI assistance or human reader studies.

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

Not applicable. This submission is for a physical medical device, not a software algorithm.

7. The type of ground truth used:

The ground truth for this device's performance is established by engineering standards and specifications (ASTM F2077, ASTM F2267). The device's performance is compared against these established standards and against the performance of predicate devices as a benchmark for substantial equivalence.

8. The sample size for the training set:

Not applicable. Training set refers to data used for machine learning models. This is mechanical testing of a physical device.

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

Not applicable. Refer to reasoning for question 8.

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The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs. CT. MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.

Interbody devices used with three screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation.

Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.

The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graff comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

The ProAM™ ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and screws manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).

The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.

The fixation devices consist of screws that are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance.

The document is a 510(k) summary for the ProAM ALIF System, which is a premarket notification for a medical device. This type of document primarily focuses on establishing "substantial equivalence" to existing legally marketed predicate devices, rather than providing a detailed report on a specific study designed to meet pre-defined acceptance criteria for performance.

While the document mentions "mechanical testing" was performed (static and dynamic compression, compression-shear, subsidence, and expulsion testing), it does not include:

• A table of acceptance criteria and reported device performance. It only states that the testing demonstrated the device performs "as well or better than the predicates."
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

These details are typical for studies assessing the performance of AI/ML or diagnostic devices against specific clinical endpoints or reference standards. The ProAM ALIF System is an intervertebral body fusion device, and the "performance data" refers to mechanical integrity and suitability for its intended biomechanical function, compared to predicate devices.

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