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The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental internal spine fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-V Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either PEEK-OPTIMA LT1 or Zeniva PEEK ZA-500 with tantalum markers. The implant is hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

The provided text describes a medical device, the Life Spine Plateau Spacer System, and its clearance process with the FDA. However, it does not contain any information regarding acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification for an intervertebral body fusion device, which is a physical implant, not an AI device. The included "Performance Data" section solely refers to mechanical testing of the implant itself (e.g., static axial compression, expulsion, subsidence, and dynamic axial compression tests) to demonstrate its substantial equivalence to predicate devices, focusing on physical and material properties.

Therefore, I cannot fulfill your request for the following sections because the provided text does not contain this type of information:

1. A table of acceptance criteria and the reported device performance: No AI device is described, so no such criteria or performance data is available.
2. Sample size used for the test set and the data provenance: No AI device or test set for an AI device is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI device or ground truth for an AI device.
4. Adjudication method: 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: 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 document discusses substantial equivalence for a physical medical device (intervertebral body fusion device) based on its design, materials, indications for use, and mechanical performance relative to existing predicate devices.

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The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-C Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone conforming to ASTM F2026 with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

The provided text describes the "Plateau Spacer System" as an intervertebral body fusion device. The performance data section indicates that the device's substantial equivalency was demonstrated through static and dynamic testing in compression and torsion, in accordance with ASTM F2077. This establishes the acceptance criteria.

However, the document does not contain information on the following points:

• Reported device performance: While it states testing was done, specific performance metrics (e.g., failure loads, displacement limits) are not reported.
• Sample size used for the test set and data provenance: No details are provided regarding the number of samples tested or where the test materials or data originated.
• Number of experts and their qualifications for ground truth: This is not applicable as the "study" is a laboratory-based biomechanical test, not a clinical study involving expert interpretation.
• Adjudication method for the test set: Not applicable for a biomechanical test.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not a study involving human readers or AI.
• Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical device, not an algorithm.
• Type of ground truth used: For a biomechanical test, the "ground truth" would be the engineering specifications and the established parameters of the ASTM F2077 standard.
• Sample size for the training set: Not applicable for a physical device undergoing biomechanical testing. The concept of "training set" is relevant for AI/machine learning models.
• How the ground truth for the training set was established: Not applicable for a physical device.

Here's the information that can be extracted into a table based on the provided text:

Acceptance Criteria and Reported Device Performance

Further details not available in the provided text:

• Sample size used for the test set and the data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (biomechanical testing).
• Adjudication method for the test set: Not applicable (biomechanical testing).
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
• The type of ground truth used: Engineering specifications and parameters defined by ASTM F2077.
• The sample size for the training set: Not applicable (biomechanical testing).
• How the ground truth for the training set was established: Not applicable (biomechanical testing).

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The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

The provided text describes a 510(k) submission for the Life Spine PLATEAU® Spacer System Titanium. This is an intervertebral body fusion device, and the submission primarily focuses on demonstrating its substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria for a new, unproven technology.

Therefore, many of the requested categories related to acceptance criteria and performance studies (like sample size for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of submission.

Here's a breakdown based on the information provided:

1. Table of acceptance criteria and the reported device performance

Details specifically requested about a "study":

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 submission relied on engineering analysis and comparison to predicate devices, not a clinical performance study with a test set of patient 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. No ground truth was established by experts for a test set in this 510(k) submission.

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

• Not Applicable. No test set or adjudication process as described was conducted.

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 a physical intervertebral body fusion device, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device.

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

• Not Applicable. For this type of device, "ground truth" generally refers to the established safety and effectiveness of the predicate devices. The "truth" for this submission is that its design, materials, and intended use are similar enough to already cleared devices.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm was used.

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

• Not Applicable. No training set for an algorithm was used.

Summary of the "study" for this device:

The "study" presented for the PLATEAU® Spacer System Titanium was an engineering analysis to demonstrate that the addition of titanium components "does not present a new worst case in performance and is substantially equivalent to the predicate systems." This means the company performed tests and analyses (e.g., mechanical, biocompatibility, design comparisons) to show that the titanium version behaves safely and effectively like the existing, cleared versions of their device and other predicate devices, without introducing new risks or performance issues. The FDA's determination of "substantial equivalence" is the "acceptance criteria" being met here.

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The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

This 510(k) summary (K121116) describes the PLATEAU®-X Spacer System, an intervertebral body fusion device. The submission is for a line extension to add a Lateral implant offering.

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

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

The document does not describe a clinical study with a test set of data or participants. The evaluation for substantial equivalence was based on engineering analysis rather than human performance data.

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

Not applicable, as no clinical study involving human readers or a test set requiring expert ground truth was conducted.

4. Adjudication method for the test set

Not applicable, as no clinical study involving human readers or a test set was conducted.

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 device is an implantable medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an implantable medical device, not an algorithm. The "standalone" performance here refers to the device's mechanical and material properties, which were assessed via engineering analysis.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. The study aimed to demonstrate that the new device (line extension) is substantially equivalent to these predicates, meaning it performs similarly and does not introduce new safety or effectiveness concerns. The method used was an engineering analysis comparing the new design to existing predicates.

8. The sample size for the training set

Not applicable, as this is not an AI/algorithm-based device requiring a training set.

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

Not applicable, as this is not an AI/algorithm-based device.

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The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

The Small PLATEAU Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Small PLATEAU Spacer System components with components from any other system or manufacturer. The Small PLATEAU Spacer System components should never be reused under any circumstances.

The provided 510(k) summary for the "Small PLATEAU® Spacer System" does not describe an acceptance criteria or a study proving that the device meets specific performance criteria in the way typically associated with AI/ML medical devices. This document is for a medical implant (an intervertebral body fusion device), not a diagnostic or prognostic algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to the information contained in this submission.

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to prove specific performance metrics against pre-defined acceptance criteria through a clinical study.

Here's an analysis based on the information provided, highlighting the non-applicability of certain requests:

1. Table of Acceptance Criteria and Reported Device Performance:

• Same intended use
• Same material
• Basic design consistency
• No new worst-case scenarios presented | The Small PLATEAU Spacer System was shown to be substantially equivalent to previously cleared devices in:
• Indications for use
• Design
• Function
• Materials used
  (Specifically, the submission aims to add additional sizes within the range of sizes offered by predicate systems and does not present a new worst case.) |

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

• Not applicable. This submission focuses on demonstrating substantial equivalence of a physical implant by comparing its characteristics and design to legally marketed predicate devices, not on evaluating an algorithm's performance on a test dataset. The "Test Data" section refers to data intended to show that a new worst case is not being presented, which typically involves engineering or biomechanical testing, not a clinical test set for diagnostic accuracy.

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

• Not applicable. No test set with ground truth established by experts is described in this submission.

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

• Not applicable. No test set requiring expert adjudication is described.

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 a physical intervertebral fusion device, not an AI/ML diagnostic tool. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable in the context of an algorithm's "ground truth." The "truth" in this context is the safety and effectiveness profile of the predicate devices against which substantial equivalence is claimed. The "predicate devices" serve as the established "ground truth" for material, design, and intended use.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of medical device submission.

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

• Not applicable. There is no "training set" or ground truth establishment in the context of an algorithm for this device.

Summary of the Study/Evidence Presented:

The "study" in this context is a comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or algorithm validation study.

The crucial information provided in the "Test Data" and "Characteristic Comparison" sections indicates:

• Objective: To add additional sizes to an existing cleared system (PLATEAU Spacer System, K093043) and demonstrate substantial equivalence.
• Methodology: Comparison of the new sizes and the Small PLATEAU Spacer System to predicate devices (Plateau Spacer System K093043 and DePuy Bengal System K081917) based on:
  • Indications for Use
  • Design
  • Function
  • Materials used (PEEK-OPTIMA LT1, 6-4 Alloy Titanium or unalloyed Tantalum markers)
• Focus: The submission argues that the new sizes fall within the range of the predicate systems, share the same intended use, material, and basic design, and that "a new worst case is not being presented." This implies that prior testing (e.g., mechanical, biocompatibility) on the predicate devices sufficiently covers the new sizes, or appropriate engineering analyses were performed to confirm that the new sizes do not introduce new risks.

In essence, the "study" is a regulatory comparison analysis designed to satisfy the 510(k) requirement for substantial equivalence, not a clinical trial to establish novel performance metrics.

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The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.

This 510(k) summary describes a spinal implant (PLATEAU Spacer System) which is a physical device, not an AI/software as a medical device (SaMD). Therefore, the concepts of acceptance criteria for algorithm performance, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance as typically applied to SaMDs are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving performance against quantitative acceptance criteria for AI model outputs, the submission aims to show that the new device shares the same intended use, materials, basic design, and fundamental technology as previously cleared devices.

Here's an analysis based on the provided text, reinterpreting some of your questions in the context of a physical medical device submission:

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

   In the context of a physical device 510(k) submission seeking substantial equivalence, acceptance criteria are generally not quantitative performance metrics for a novel algorithm. Instead, the "acceptance criteria" are demonstrating equivalence to predicate devices across key characteristics. "Reported device performance" would refer to how the device aligns with these characteristics.

   Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance
   Intended Use (same as predicate)	"The additional sizes fall within the range of sizes offered in the predicate systems. Additionally they have the same intended use..."
   Material (same as predicate)	"...material..." (PEEK-OPTIMA LT1 with tantalum/titanium markers, compliant with ASTM F2026)
   Basic Design (same as predicate)	"...and basic design as the predicate systems." (Intervertebral body fusion device, hollow for bone graft, with teeth)
   Performance (no new worst-case scenario due to added sizes)	"Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario..."

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

   Not applicable. This is not a study involving data for an AI model. The "test set" here would conceptually be a comparison to the predicate devices themselves, rather than a dataset. The document doesn't detail any specific 'test' data provenance for the physical device, beyond general material and design specifications.

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 for an AI model is not relevant here. The "ground truth" for a physical medical device's substantial equivalence is its conformity to established standards, materials, and designs, as assessed by engineering and clinical experts within the manufacturing company and subsequently by the FDA reviewers.

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

   Not applicable for a physical device submission.

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 device is a physical implant, not an AI system or diagnostic tool that would involve human readers or AI assistance.

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

   Not applicable. This device is a physical implant, not an algorithm.

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

   For a physical device 510(k) submission, the "ground truth" for proving safety and effectiveness (as demonstrated through substantial equivalence) is typically based on:

   • Material specifications and testing: Adherence to standards like ASTM F2026.
   • Biocompatibility data: Established for the PEEK-OPTIMA LT1 material.
   • Mechanical testing: To ensure the implant can withstand anticipated physiological loads and that new sizes don't introduce new worst-case scenarios. (General statement in the document: "Information has been presented to show that the addition of sizes to the system do not impose a new worst case scenario...").
   • Clinical history of predicate devices: The track record of similar devices already on the market forms the basis for demonstrating safety and effectiveness without requiring new clinical trials for minor modifications.

8. The sample size for the training set

   Not applicable. This is not an AI model.

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

   Not applicable. This is not an AI model.

Ask a specific question about this device

The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

The Small PLATEAU Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers. The implant is hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

The provided text describes the 510(k) submission for the Plateau-C Spacer System, a medical device. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating AI performance. Therefore, many of the requested fields related to AI, ground truth, experts, and human reader performance are not applicable.

Here's an analysis based on the provided text:

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

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a biomechanical testing study conducted in accordance with ASTM (American Society for Testing and Materials) standards ASTM F2077 and F2267.

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

• Sample Size: 7 implants of 14mm x 14mm (this was determined to be the optimal and worst-case size for testing).
• Data Provenance: The biomechanical testing was performed at Empirical Testing, an independent testing facility. The report number is #199-534806-115. No country of origin is explicitly stated for Empirical Testing, but the submission is to the U.S. FDA, implying a U.S.-based or recognized facility. This was a prospective test designed to evaluate the physical properties of the device.

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

This section is Not Applicable (N/A). This submission is for a physical medical device (intervertebral spacer) based on material biocompatibility and biomechanical performance, not an AI or diagnostic device that requires expert-established ground truth on patient data. The "ground truth" here is the physical performance against established engineering standards.

4. Adjudication method for the test set

This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or AI output. This study involved objective biomechanical testing where metrics are measured directly against standards.

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 section is Not Applicable (N/A). This is not an AI-assisted diagnostic device, so no MRMC study or AI assistance evaluation was performed.

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

This section is Not Applicable (N/A). This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Biocompatibility Standards: Adherence to ISO 10993 standards.
• Biomechanical Performance Standards: Adherence to ASTM F2077 and F2267 mechanical testing standards.
• Predicate Device Performance: The biomechanical results were compared against the known performance characteristics of the legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

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

This section is Not Applicable (N/A). As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine.

The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either analonical considered one (PEEK-OPTIMA LT1) with titanium markers. The implant is hollow to I oryeneredier with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to as in the interface with the vertebral endplates to prevent rotation and/or migration.

The provided text describes a 510(k) summary for the "PLATEAU® Spacer System," an intervertebral body fusion device. While it mentions "Performance Data" and biomechanical testing, it does not provide specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for a diagnostic AI device.

Here's a breakdown of why it's not possible to extract the requested information based on the provided text:

• Device Type: The PLATEAU® Spacer System is a physical medical implant (intervertebral body fusion device), not a diagnostic AI device. The questions in the prompt (e.g., about sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment) are relevant to AI/diagnostic software.
• Performance Data: The text states, "Biomechanical testing in accordance with ASTM standards was conducted to demonstrate substantial equivalence to the predicate intervertebral body fusion devices." This refers to physical and mechanical properties, not diagnostic accuracy.
• Substantial Equivalence: The primary goal of a 510(k) for this type of device is to demonstrate "substantial equivalence" to a legally marketed predicate device, meaning it's as safe and effective as the existing device. This is different from meeting specific numerical performance targets for an AI algorithm.

Therefore, the requested information cannot be found in the provided document.

To directly answer your questions based on the absence of this information for an AI device:

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

• Not Applicable: The device is a physical implant, not an AI diagnostic tool. Acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC) and reported device performance metrics are not included. The document only mentions "Biomechanical testing in accordance with 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)

• Not Applicable: No test set in the context of AI performance is discussed. The "testing" referred to is biomechanical.

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: No ground truth establishment for a diagnostic test set is mentioned.

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

• Not Applicable: No diagnostic test set or adjudication method is mentioned.

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 study or AI assistance is mentioned as the device is a physical implant.

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

• Not Applicable: The device is a physical implant, not an algorithm.

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

• Not Applicable: No ground truth in the context of diagnostic accuracy is mentioned.

8. The sample size for the training set

• Not Applicable: No training set for an AI algorithm is mentioned.

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

• Not Applicable: No ground truth for a training set is mentioned.

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