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The Innovasis PEEK IBF System (Px, Px HA and TxHA) is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar 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 a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis TxHA PEEK IBF Spinal System is a line extension of the Px Posterior Spinal IBF System, an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The Px IBF was submitted to FDA under K150500 in February 2015, and was cleared for sale in the USA on June 19, 2015. The Px HA design manufactured using Invibio® PEEK-Optima® HA Enhanced was cleared under K151785 on October 14, 2015. In this material, hydroxyapatite (HA), is integrated with Invibio's PEEK-OPTIMA Natural.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support PLIF/TLIF surgeries are provided with the implants in sterilization trays.

The Px implants are machined from medical grade Solvay Zeniva ZA-500 or Evonik VESTAKEEP i4R PEEK. The Px HA and TxHA implants are machined from Invibio® PEEK-OPTIMA® HA Enhanced* polyetheretherketone with hydroxyapatite. The radiographic markers meet ASTM F560 for unalloyed Tantalum. HA is a naturally occurring mineral in bone and is widely used in the orthopedic field.

The provided text is a 510(k) Premarket Notification from the FDA regarding an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to previously cleared predicate devices based on non-clinical performance testing.

It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of clinical performance or algorithm-based performance. The document focuses on regulatory approval based on mechanical and material equivalence to existing devices.

Therefore, I cannot provide the requested information from the given text.

If this were a document about an AI/ML medical device, the information I'd look for to answer your questions would typically be in sections detailing clinical studies, algorithm validation, or performance evaluation.

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The Innovasis Px HA™ PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar 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 a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.

This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px HA implant is intended to be packed with autograft.

The Innovasis Px HA™ PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Implants are manufactured by Innovasis from Invibio® PEEK-OPTIMA® HA Enhanced*. Hydroxyapatite (HA) is fully integrated into the PEEK-OPTIMA. The device is radiolucent allowing straightforward assessment of the fusion process, while tantalum spheres are located around the periphery of the device to allow implant visualization during and after surgery.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support the PLIF surgery are provided with the implants in custom sterilization trays.

The provided document is a 510(k) summary for the Innovasis Px HA™ PEEK IBF System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a novel artificial intelligence/machine learning device.

Therefore, many of the requested categories for describing an AI study are not applicable to this document. The document primarily discusses the non-clinical performance testing of the physical device.

Here's the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a numerical or categorical format for a defined study endpoint. Instead, it states that "Performance testing per ASTM F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion indicates that the Px HA PEEK IBF is capable of performing in accordance with its intended use." It implies that meeting the standards of these ASTM tests demonstrates acceptable performance. However, specific numerical thresholds or target performance metrics are not listed.

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

• Sample Size for Test Set: Not specified. The document mentions "Performance testing" on "devices" and "new and artificially aged devices" but does not provide specific sample quantities used for these tests.
• Data Provenance: Not applicable in the context of clinical data. The performance tests are stated as non-clinical, likely mechanical and material testing conducted in a lab environment.

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

This information is not applicable. The ground truth for this device is based on standardized mechanical testing performed in a laboratory, not on expert interpretations of medical data.

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

This information is not applicable, as the evaluation is based on objective mechanical tests, not subjective interpretations requiring adjudication.

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 information is not applicable, as this document is not about an AI device.

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

This information is not applicable, as this document is not about an AI device.

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

The ground truth for the non-clinical performance tests is based on established engineering and material science standards (ASTM F2077-11, ASTM F2267-04, ASTM F560-13, ASTM F983-86, ASTM F2026-14, ISO 17665-1:2006). These standards define the methodologies and expected performance characteristics for intervertebral body fusion devices.

8. The sample size for the training set:

This information is not applicable, as this document is not about an AI device.

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

This information is not applicable, as this document is not about an AI device.

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