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The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

The Expanding Innovations X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment in both the parallel and lordotic configurations. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

I am sorry, but the provided text from the FDA 510(k) K222797 submission for the "X-Pac Expandable Lumbar Cage System" does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or diagnostic algorithm.

The document is a traditional 510(k) for a medical device (an intervertebral body fusion device) that focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and performance within the context of mechanical and biological functionality, not algorithmic performance or diagnostic accuracy.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for an AI or diagnostic algorithm's performance.
2. Sample sizes used for the test set and the data provenance: Not applicable as there's no AI/diagnostic study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 5, H. Technological Comparison, I. Performance Data) states:

"A risk assessment was conducted to confirm that the modification to the Indications for Use Statement does not introduce new issues of safety or effectiveness."

This refers to a standard risk assessment for mechanical devices, not data-driven performance metrics for an AI/diagnostic system.

In summary, the provided document relates to a physical implantable medical device, not a software device or AI-powered diagnostic tool, and therefore does not contain the information you are requesting about acceptance criteria and performance studies for an algorithmic device.

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The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices 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).

SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).

The provided document is a 510(k) summary for a medical device called "Spectrum Spine Expandable Cages (SSEC)". This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study for AI performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and study data for an AI-powered device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI
• Sample size and data provenance for an AI test set
• Number and qualifications of experts for AI ground truth establishment
• Adjudication methods for AI test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
• Standalone AI performance
• Type of ground truth used for AI
• Training set sample size and ground truth establishment for AI

The information within the document pertains to mechanical and material testing of an intervertebral fusion device (implants), which are entirely different types of tests than those required for an AI-based medical device. The "Performance Data" section discusses:

• Static Axial Compression per ASTM F2077
• Static Compressive Shear per ASTM F2077
• Static Subsidence per ASTM F2267 and ASTM F2077
• Static Expulsion
• Dynamic Axial Compression per ASTM F2077
• Dynamic Compressive Shear per ASTM F2077

These are all mechanical tests to ensure the physical integrity and durability of the spinal implant, not performance metrics for an AI algorithm.

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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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The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).

PROW FUSION-L is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-L is provided in different sizes to fit the anatomical needs of a wide variety of patients. PROW FUSION-L is manufactured from titanium alloy per ASTM F136 and Polyetheretherketone per ASTM F 2026. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. PROW FUSION-L is to be filled with autogenous bone graft material.

Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae. The devices require the use of commercially available supplemental spinal fixation systems.

This document describes a 510(k) premarket notification for the "PROW FUSION-L" intervertebral body fusion device. A 510(k) is a submission to the FDA demonstrating that the device is at least as safe and effective as a legally marketed predicate device. This type of submission generally does not require clinical trials with acceptance criteria and statistical performance metrics in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and MRMC studies is not applicable to this 510(k) submission.

Instead, the submission relies on the concept of substantial equivalence to a predicate device, demonstrated primarily through mechanical testing.

Here's the summary of what is provided:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. As this is a 510(k) for substantial equivalence, formal acceptance criteria in the context of clinical performance (sensitivity, specificity, etc.) are not presented. The "acceptance" is based on the mechanical test results demonstrating equivalence to the predicate and compliance with relevant ASTM standards.

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

• Test Set Sample Size: Not specified in terms of human subjects or clinical cases. The "test set" here refers to the physical devices subjected to mechanical testing. The number of devices tested for each mechanical test (static and dynamic axial compression, compression-shear, subsidence, expulsion, wear particle assessment) is not explicitly stated.
• Data Provenance: The mechanical testing was conducted to demonstrate substantial equivalence to the predicate device and compliance with ASTM standards. The submission originates from NLT SPINE Ltd. in Kfar-Saba, Israel. The context suggests that the testing was performed in a lab setting rather than involving human data.

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 in the context of clinical expert consensus is not relevant for this type of submission focused on mechanical equivalence. The "ground truth" for mechanical testing is adherence to predefined engineering specifications and performance within established ASTM standards.

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

• Not Applicable. Adjudication methods are relevant for clinical studies where expert review is needed for diagnoses or outcomes. This document describes 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. No MRMC or clinical comparative effectiveness study involving human readers or AI is mentioned, as this is a mechanical device, not an imaging or AI diagnostic tool.

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

• Not Applicable. This is a physical intervertebral body fusion device, not an algorithm or AI system.

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

• For the mechanical performance data, the "ground truth" is adherence to established ASTM (American Society for Testing and Materials) standards and demonstrating performance similar to the predicate device. The specific standards cited are ASTM F2077 (for static and dynamic axial compression, static and dynamic compression-shear) and ASTM F2267 (for subsidence).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of a machine learning algorithm for this physical device.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant.

In summary, the PROW FUSION-L device gained market clearance via a 510(k) submission based on:

• Substantial Equivalence: To several predicate devices including Life Spine, Longbow Spacer System (K133717).
• Mechanical Performance Data: Consisting of static and dynamic axial compression, static and dynamic compression-shear (according to ASTM F2077), subsidence (according to ASTM F2267), and additional expulsion and wear particle assessment testing.
• Compliance with Guidance: Per "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007.

The "study" that proves the device meets the criteria is a set of mechanical tests designed to show that the device performs functionally and structurally equivalent to its predicate.

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The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

The provided text does not contain information regarding software or AI device performance, acceptance criteria, or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification summary for a medical device called the "Spine Wave Gen II Expandable Interbody System," which is a physical implant for intervertebral body fusion procedures.

The information provided covers:

• Device Name: Spine Wave Gen II Expandable Interbody System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at specific levels (L2-S1 posterior surgical approach, L2-L5 lateral surgical approach), used with autogenous bone graft and supplemental fixation, after at least six months of non-operative treatment.
• Device Description: Composed of titanium alloy, PEEK-OPTIMA with BaSO4, and commercially pure titanium wafers stacked into an expandable implant. Includes a delivery device and is provided sterile.
• Predicate Devices: Multiple predicate devices from Spine Wave, Globus Medical Inc., LDR Spine USA, Ulrich GmbH & Co. KG, Biomet Spine, and Synthes Spine Co. LP.
• Non-Clinical Performance Data: Lists various ASTM standards for testing coating microstructure, shear testing, shear fatigue testing, tensile testing, abrasion testing, static and dynamic axial compression, static and dynamic compression shear, subsidence, and wear debris analysis. These are mechanical and material property tests for the physical implant, not software.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving a device meets acceptance criteria related to a software or AI device, as that information is not present in the provided document.

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The Integra® Expandable Intervertebral Body Fusion Device (IBD) System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASTM F2026), titanium (Ti-6Al-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiographic tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. They are available in a range of sizes, and their heights can be intra-operatively expanded to the desired height to accommodate variations in surgical approach and patient anatomy. Non-expandable implants are manufactured from PEEK-OPTIMA® LT1 only with radiopaque markers. The system also includes instruments to assist with the surgical procedure/ implantation, as well as trays and caddies for organization.

This is a medical device application for an intervertebral body fusion device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not applicable in this context.

Here's a breakdown of why the requested information cannot be provided given the input:

• Device Type: The Integra Expandable IBD System is a physical medical implant (intervertebral body fusion device) made of PEEK, titanium, and cobalt chromium. It is not a software algorithm or an AI/ML diagnostic tool.
• Regulatory Pathway: This is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices. This pathway typically relies on non-clinical (bench) testing and comparison to existing devices, rather than large-scale clinical trials or AI/ML performance studies with specific acceptance criteria like sensitivity, specificity, etc.
• Non-Clinical Testing: The submission explicitly states "Non-clinical Testing: The Integra Expandable IBD System demonstrated equivalent performance to the predicate systems through static and dynamic axial compression shear testing per ASTM F2077, with wear evaluation per ASTM F1877, subsidence testing per ASTM F2267, and expulsion testing per ASTM Draft F04.25.0202. In addition, a cadaver implantation study was conducted to demonstrate usability and graft containment/volume of the subject device."
• Clinical Testing: The submission explicitly states "Clinical Testing: No clinical testing was required to demonstrate equivalence."

Therefore, I cannot populate the table or answer the questions as they pertain to AI/ML device validation. The provided document concerns a traditional medical device demonstrating substantial equivalence through non-clinical performance standards and a cadaver study, not through a study involving AI performance metrics, readers, or ground truth as defined in an AI context.

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