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The EL CAPITAN Anterior Lumbar Interbody 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 L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.

The EL CAPITAN Anterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis)

This document is a 510(k) summary for the EL CAPITAN Anterior Lumbar Interbody System, a medical device for spinal fusion. This device is not an AI/ML-enabled device, and therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable.

The document explicitly states: "No clinical studies were performed." This indicates that the device's substantial equivalence to predicate devices was based on non-clinical tests (mechanical and material properties), rather than clinical performance data. Therefore, there are no acceptance criteria related to AI/ML performance metrics, nor any studies proving such performance.

The non-clinical tests conducted establish the device's mechanical safety and performance, demonstrating equivalence to predicate devices. The acceptance criteria for these non-clinical tests would be the established ASTM standards mentioned (e.g., ASTM F2077, ASTM F1717, ASTM F2267).

To summarize why the specific points of your request cannot be answered from this document:

• Acceptance Criteria & Reported Device Performance (Table): Not applicable for AI/ML performance. The device's performance is shown through compliance with mechanical testing standards.
• Sample sizes & Data Provenance (Test/Training Sets): Not applicable as there is no AI/ML component. Mechanical tests have their own sample size requirements per ASTM standards.
• Number of experts & Qualifications: Not applicable as there is no AI/ML component and no clinical studies were performed requiring expert reading.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of ground truth: Not applicable for AI/ML. The "ground truth" for this device's safety and efficacy is derived from its mechanical properties, material biocompatibility, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing.
• Sample size for training set & How ground truth established: Not applicable.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

1. Intended Use
2. Design
3. Materials Used (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol)
4. Mechanical Safety and Performance (Non-clinical tests: Static/Dynamic Compression, Static/Dynamic Compression Shear, Subsidence, Expulsion per ASTM standards).

Therefore, this document does not contain the information required to answer your prompt, as it pertains to a traditional medical device, not an AI/ML-enabled one.

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The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).

This is a 510(k) summary for a medical device called FBC 921™ (ALIF), an intervertebral body fusion device. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in response to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for specific quantitative metrics that are then directly compared to "reported device performance" in a separate column. Instead, it describes compliance with recognized standards and a general conclusion of meeting or exceeding predicate device performance.

However, based on the non-clinical performance data section, we can infer the types of tests conducted and the implicit acceptance criteria:

2. Sample Size Used for the Test Set and the Data Provenance

The document describes non-clinical (mechanical and material) testing. It does not mention a "test set" in the context of patient data or clinical images. The tests performed are on the device itself (e.g., in a lab setting). Therefore, questions regarding data provenance (country, retrospective/prospective) are not applicable here.

• Sample Size for Test Set: Not specified in terms of patient data. For mechanical testing, industry standards typically dictate the number of samples, but specific counts are not provided in this summary.
• Data Provenance: Not applicable as no clinical data is presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this 510(k) summary. This document details non-clinical, mechanical, and material testing of an implantable device to demonstrate substantial equivalence to predicate devices. It does not involve a "test set" in the context of expert-labeled clinical data for an AI/algorithm (which is what this question implies).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable for the same reasons as point 3. There is no clinical test set requiring expert 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 question is not applicable. This is a 510(k) for an implantable medical device (spinal fusion system), not an AI/CADe/CADx device that would assist human readers in interpreting medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is 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 the non-clinical performance data, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM standards) and internal protocols, along with the performance characteristics of the predicate devices. The FBC 921™'s performance is compared against these standards and predicate device performance to show it "meets or exceeds" them.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" mentioned or implied, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as point 8.

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The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior lateral above the bifurcation (L1-L5) of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

The subject device represents an expansion of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. This system consists of a series of 3-hole and 4-hole plates as well as bone screws in a variety of sizes. The 3-hole plates are intended for use as an anterior fixation device while the 4-hole plates are intended for use as an anterior lateral fixation device. The system incorporates a locking mechanism to prevent the bone screws from backing out by covering the bone screw heads. Like its predicate counterpart, the subject device is intended for use as an anterior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons with options in the placement of the device to avoid interference with the vasculature, while still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.

The provided text does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets such criteria. This document is a 510(k) summary for a medical device (PYRAMID® +4 Anterior Lumbar Plate System), which primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested table or answer the specific questions about standalone studies, MRMC studies, sample sizes, ground truth establishment, or expert qualifications, as this information is not present in the provided text.

The closest relevant information, regarding how the device ensures its intended function and meets a standard, is mentioned under "V. Substantial Equivalence," which states: "Documentation, including mechanical test results, provided has demonstrated that the PYRAMID® +4 Anterior Lumbar Plate System is substantially equivalent to similar previously cleared devices..." However, it does not elaborate on what these mechanical tests entailed, what the acceptance criteria were, or the specific performance metrics.

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The CITADEL™ Anterior Lumbar Plate System is intended for use in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The CITADEL™ Anterior Lumbar Plate System consists of plates of various lengths with variable or fixed bone screws for spinal fixation of the anterior or anterolateral vertebral bodies of the lumbar or lumbosacral spine (L1-S1). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

The provided text describes a medical device, the "CITADEL™ Anterior Lumbar Plate System," and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to predicate devices through mechanical testing. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device.

Here's an analysis based on the provided text:

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

• Not found: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented." However, it does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the explicit performance results of the CITADEL™ device against these criteria. It only asserts that the device is "similar" to predicate devices in "technical characteristics, performance, and intended use."

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/Not found: This device is a mechanical orthopedic implant, not an AI or algorithm-based diagnostic tool. Therefore, concepts like a "test set" with data provenance (country, retrospective/prospective) are not relevant in the context of the device described here. Mechanical testing typically uses physical samples of the device components. The document does not specify the number of samples used for the mechanical tests.

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 using expert consensus is relevant for diagnostic performance studies, not for the mechanical testing of an implant.

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

• Not applicable: Adjudication methods are relevant for expert review in diagnostic studies, not for 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 a mechanical implant, 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 mechanical implant, not an algorithm.

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

• Not applicable: For mechanical devices, performance is typically measured against established engineering standards (e.g., ASTM standards) rather than clinical ground truth types like pathology or outcomes data in the context of an AI model's performance. The "ground truth" here would be the physical properties and mechanical behavior of the device under test, compared to relevant standards or predicate devices.

8. The sample size for the training set

• Not applicable: This device is a mechanical implant and does not involve a "training set" in the sense of machine learning.

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

• Not applicable: As above, this concept does not apply to a mechanical implant.

In summary, the provided document relates to a 510(k) submission for a mechanical spinal implant. It confirms that mechanical testing was performed according to a guidance document for spinal systems. However, it does not offer the detailed information requested about acceptance criteria and a study design that would be relevant for an AI/algorithm-based medical device.

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The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.

The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The AEGIS Anterior Lumbar Plate System consists of an assortment of plates and screws.

The AEGIS Anterior Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document describes the regulatory submission for the AEGIS Anterior Lumbar Plate System, a medical device. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance.

The provided text is a 510(k) summary for a spinal implant system, which focuses on device description, intended use, materials, and substantial equivalence to predicate devices, rather than performance as would be measured for AI/ML systems. Therefore, most of the requested information regarding AI/ML study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document.

However, I can extract the information provided about the performance data and the type of evaluation conducted for this medical device:

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

The document states: "Performance data were submitted to characterize the AEGIS Anterior Lumbar Plate System components."

Without the actual performance data or explicit acceptance criteria from the 510(k) submission, a detailed table cannot be created. For a mechanical implant like this, "acceptance criteria" generally refer to specific mechanical testing standards (e.g., fatigue strength, torsional rigidity) that the device must meet, and "reported device performance" would be the results of those tests. The 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing to show similar performance characteristics.

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. This is a medical device (spinal implant) approval, not an AI/ML diagnostic or predictive device. The "test set" in this context would refer to mechanical test specimens, and not a dataset of patient information. The document does not specify the number of test specimens or the provenance of the material testing data, but it is implied to be laboratory-based testing of the device components.

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 this device's approval would relate to established engineering principles, material science standards, and the performance of predicate devices, not expert consensus on diagnostic interpretations.

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

Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or AI/ML ground truth establishment, neither of which are detailed in this 510(k) summary for a mechanical device.

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 not an AI-assisted diagnostic or therapeutic device.

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

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

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

For a mechanical device like this, the "ground truth" for demonstrating performance usually comes from:

• Mechanical testing standards: Compliance with established ASTM or ISO standards for spinal implants (e.g., fatigue, static strength).
• Material properties: Verification that the materials used (ASTM F-136 implant grade titanium alloy) meet published specifications.
• Predicate device comparison: Performance is often compared against legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

The T-PLATE Anterior Fixation System is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The T-PLATE Anterior Fixation System is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The T-PLATE Anterior Fixation System components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grad titanium alloy. Stainless steel and titanium components must not be used together in a construct.

The provided text describes a medical device, the T-PLATE Anterior Fixation System, and its regulatory approval process, specifically a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical study with acceptance criteria and performance metrics in the way one might for a novel AI device or a drug.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this document. The "study" mentioned is mechanical testing to demonstrate substantial equivalence, not a clinical trial with human subjects, AI algorithms, or ground truth established by experts.

Here's an breakdown based on the provided text, indicating which information is available and which is not:

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

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

• Sample Size: Not specified (refers to mechanical testing, not a patient test set).
• Data Provenance: Not specified. It's mechanical testing of the device itself, not 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 expert consensus on medical images or diagnoses is not relevant for mechanical testing of a spinal fixation system. Substantial equivalence is based on engineering principles and comparison to a predicate device.

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

• Not applicable. There was no "test set" of patient data requiring adjudication in a clinical or diagnostic sense.

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 document describes a physical medical device (spinal implant), not an AI system.

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)

• Not applicable. The "ground truth" for substantial equivalence under 510(k) is the performance and characteristics of the legally marketed predicate device (PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM). The new device is evaluated against engineering benchmarks to ensure it is similar enough to the predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

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

Summary based on the document:

The T-PLATE Anterior Fixation System gained regulatory clearance through a 510(k) premarket notification. This process determines substantial equivalence to an existing legally marketed device (the PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM, K013665). The evidence provided for this equivalence was mechanical testing of the device. The document does not describe clinical studies involving human subjects, AI performance, or ground truth established by medical experts for a diagnostic task.

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The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting of a variety of shapes and sizes of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.

The provided text describes a 510(k) submission for the Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not a study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI/human reader performance is not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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 is for a medical device (spinal fixation system) and its substantial equivalence is demonstrated through mechanical testing, not a clinical study with a test set of human subjects or 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 expert consensus is not relevant for this type of mechanical device submission. The "ground truth" here would be the performance of the predicate device against which the new device is compared.

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

• Not Applicable. This is not a study requiring adjudication of expert opinions.

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

• No. This is not an AI-assisted diagnostic or interpretive device.

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

• No. This is a physical medical implant, not an algorithm.

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

• The "ground truth" or benchmark here is the performance of the predicate device (K013665, PYRAMID™ ANTERIOR PLATE Fixation System) as established by its clearance and subsequent safety and effectiveness. The new device's mechanical performance is compared to this established predicate.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of mechanical testing for substantial equivalence.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment in this context.

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