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The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:

• Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• o Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
• Pseudoarthrosis ●
• Failed previous fusions ●
• Spondylolisthesis ●
• Spinal Stenosis ●

The Medina Anterior Cervical Plate System (ACP) System is intended for anterior screw fixation to the cervical spine. The Medina ACP system consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and commercially pure titanium per ASTM F67. Components of the Medina ACP System should not be used with components from any other system or manufacturer, with exception of the Cage Pins which are to be used only with Alliance Spine's Alamo C or Alamo C-Ti systems. The Medina ACP System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.

The provided text describes a medical device, the Medina Anterior Cervical Plate System, and its substantial equivalence determination by the FDA. However, the text does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in relation to an AI algorithm.

The information provided focuses on:

• Regulatory Clearance (K201521): The FDA's substantial equivalence determination for the Medina Anterior Cervical Plate System.
• Device Description: What the device is, its materials, and intended use.
• Indications for Use: The medical conditions for which the device is intended.
• Technological Characteristics: Comparison to predicate devices.
• Performance Data (Non-Clinical): Mechanical testing (static compression bending, static torsion, dynamic compression bending) against ASTM F1717, concluding substantial equivalence to predicate devices in terms of strength.

Therefore, I cannot provide the requested table and study details as they pertain to AI algorithm performance and acceptance criteria, as this information is not present in the provided document.

The document describes a physical medical device (an anterior cervical plate system) and its mechanical performance testing, not an AI or software-as-a-medical-device (SaMD) product.

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The Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima® LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the vertebral end plates. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges (teeth) to improve fixation and stability and prevent back out and migration.

This document is a 510(k) premarket notification for a medical device called Alamo® C, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text because this is not the type of document that would typically contain such information. This 510(k) summary relies on non-clinical performance testing and comparison to predicate devices, explicitly stating that "No clinical studies were conducted."

Here's a breakdown of the available information based on your request:

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

The document does not explicitly state acceptance criteria in the format of a table with quantitative thresholds and corresponding performance outcomes for a clinical study. Instead, it refers to performance testing conducted in accordance with specific ASTM standards to establish substantial equivalence with a predicate device.

The reported performance is qualitative:

• "The results obtained demonstrate the subject Alamo C device functions as intended and is substantially equivalent to the predicate Alamo C device."

The types of tests performed were:

• Static axial compression
• Dynamic axial compression
• Static torsion
• Subsidence
• Expulsion

These are non-clinical/bench testing results, not clinical performance metrics. The underlying acceptance criteria for these tests would be the pass/fail criteria defined within the referenced ASTM standards (ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02) and likely internal company specifications for equivalence to the predicate.

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

• Sample Size: Not specified in the document. This typically refers to the number of devices tested in the non-clinical performance evaluations.
• Data Provenance: The tests were conducted internally or by a contracted lab as part of the 510(k) submission process for the new titanium version of the Alamo® C device. It's not "data provenance" in the sense of clinical patient data (e.g., country of origin, retrospective/prospective), as no clinical studies were conducted.

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

• This is not applicable as no clinical study was conducted that would require expert-established ground truth for patient outcomes or image annotations. The "ground truth" for the non-clinical tests would be the established scientific principles of mechanical testing and material properties as defined by the ASTM standards.

4. Adjudication method for the test set

• Not applicable for non-clinical performance 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 device is an intervertebral body fusion device, not an imaging AI diagnostic tool. No MRMC study was conducted.

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 the non-clinical performance tests, the "ground truth" is based on the engineering principles, material science, and mechanical testing standards (ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02). The performance of the new device was compared to the predicate device, implying that the predicate's established performance served as a benchmark for equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable.

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The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.

The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects. The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.

This is a 510(k) premarket notification for a medical device, the Alliance Spine RAAS Cranial Plating System. This type of submission is focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device), rather than proving the device meets explicit acceptance criteria through a standalone clinical study like a De Novo application might.

Therefore, the structure of the response will reflect that the "acceptance criteria" are essentially the performance characteristics of the predicate devices, and the "study" is the non-clinical testing demonstrating similar performance.

Acceptance Criteria and Study for the Alliance Spine RAAS Cranial Plating System (K141123)

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly derived from the performance of the predicate devices. The new device is considered substantially equivalent if its performance is comparable.

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

• Test Set Sample Size: The document does not specify a precise sample size for each test (e.g., number of burr hole plates or screws tested). It refers to "Worst case Burr Hole plates" and "Worst case screws," implying a representative selection but not a fixed number.
• Data Provenance: The data is generated from non-clinical bench testing, conducted specifically for this 510(k) submission. The location of the testing is not specified. It is a prospective generation of data for the submission.

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

This information is not applicable (N/A) in this context. For a 510(k) submission, the "ground truth" for mechanical performance is established through adherence to recognized international and national standards (e.g., ASTM F382, ASTM F543) and comparison to the known performance of predicate devices. There wouldn't be a panel of human "experts" establishing a ground truth for mechanical test results in the same way they might for clinical interpretations.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Mechanical testing results are objective measurements against defined standards and predicate performance, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a cranial plating system, a physical implant, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This information is not applicable (N/A). This product is a physical medical device (cranial plating system), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence in this 510(k) is:

• Adherence to recognized industry standards: ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
• Performance metrics of predicate devices: The tests were designed to show that the subject device's mechanical properties (e.g., peak load, stiffness, torque values) were "acceptable based on intended use and predicate data," implying that the predicate's performance served as the benchmark.

8. The Sample Size for the Training Set

This information is not applicable (N/A). As this is a physical medical device without any AI/machine learning components, there is no "training set."

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

This information is not applicable (N/A), as there is no training set for this type of device.

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The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:
• Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal Stenosis

The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included.

The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).

This document is a 510(k) premarket notification for the Nakoma ACP System, a spinal intervertebral body fixation orthosis. It includes information about the device's indications for use, its comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for performance in a pass/fail quantifiable manner, but it does describe the non-clinical testing performed and the conclusion drawn from it. The "acceptance criteria" here are implied to be "perform equivalently to the predicates" as verified by the stated tests.

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

The document mentions "non-clinical testing" and refers to ASTM F1717 for mechanical tests. It states "the subject devices were found to perform equivalently to the predicates." However, it does not specify the sample size used for these tests. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as these are mechanical tests, not clinical data from patients.

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)

This question is not applicable to the provided document. The device in question is a medical implant (spinal fixation system), and the evaluation discussed is based on non-clinical mechanical testing (ASTM F1717). Therefore, there is no "ground truth" derived from expert consensus on medical images or patient outcomes in this context.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where disagreements need to be resolved. This document focuses on non-clinical mechanical testing, which does not involve subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states under "(b)(2) Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The device is a spinal implant, not an AI-assisted diagnostic tool for human readers.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical medical implant, not a software algorithm.

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

The "ground truth" for the non-clinical testing was based on the established performance characteristics and specifications of the predicate devices as determined by ASTM F1717 standards for mechanical testing. The goal was to show equivalence to these established benchmarks.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence of a physical medical device through mechanical testing, not on developing or training an algorithm.

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

This question is not applicable, as there is no training set involved in this submission.

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The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

The Alamo T device is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. Supplemental fixation and autograft is required to facilitate fusion.

The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.

The provided document is a 510(k) premarket notification for a medical device called the "Alamo T Intervertebral Body Fusion Device." This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. In such submissions, the acceptance criteria and study data are presented somewhat differently than for a novel device undergoing clinical trials.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission asserting substantial equivalence (SE) for modifications to an existing device and new sizes, the "acceptance criteria" are intrinsically tied to demonstrating that the new device performs similarly to, or no worse than, the predicate device, especially concerning mechanical and biological integrity. The performance is assessed against the established safety and efficacy of the predicate, rather than novel clinical endpoints.

2. The device's ability to maintain structural stability at the fusion site following discectomy is preserved.
3. The risk of migration or back-out is not increased. | "Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary."

The FMEA (Failure Modes and Effects Analysis) would identify potential failure modes due to changes and assess their mitigation. The engineering rationale would involve comparing the mechanical characteristics of the new sizes/designs to the predicate, likely using established biomechanical principles and potentially referencing existing test data for the predicate.

Specific performance metrics (e.g., stiffness, compressive strength, torsional stability) against a target (e.g., "equal to or greater than predicate") are implied but not explicitly stated in this summary. |
| Biocompatibility & Material Safety | The materials used (PEEK Optima® LT1 and Tantalum markers) are biocompatible and safe for long-term implantation, consistent with established materials in the predicate devices and per relevant ASTM standards. | The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. These are the same materials as the predicate. This reliance on established materials compliant with ASTM standards implies biocompatibility and material safety are met. No new testing explicitly detailed, relying on existing material characterization. |
| Functional Equivalence (Graft Accommodation, Fixation) | 1. The hollow center accommodates bone graft effectively.
2. Inferior and superior surfaces with ridges ("pyramid pattern" and "teeth") improve fixation and stability and prevent back-out and migration.
3. Graft volume and window size are adequate and comparable to appropriate predicates. | "The device footprint has a hollow center to accommodate bone graft..." and "the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration."

The document states: "Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows." This indicates comparison to established functional benchmarks in similar devices. New sizes were validated using Life Spine's PLATEAU system as a "dimensional predicate." The "Teeth" feature is also compared to the predicate Alamo T. |
| Indicated Use & Clinical Application | The device performs its intended function for spinal fusion in skeletally mature patients with DDD at L2-S1, requiring supplemental fixation and autograft, implanted via a transforaminal approach, without altering the fundamental scientific technology or increasing risks. | "The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology." The "Indications for Use" statement is identical to the predicate (K120401). This statement implicitly confirms that the device is expected to perform equivalently in a clinical setting based on its design and material similarity and validated mechanical properties. No clinical testing was required to demonstrate substantial equivalence, implying the modifications are considered minor enough not to necessitate new human studies. |
| Sterilization & Radiographic Visualization | 1. Sterilization method (steam by end user) is effective and validated.
2. Tantalum markers allow for adequate radiographic visualization. | Sterilization: "End User (Steam)" - stated to be the same as the predicate.
Radiographic Markers: "Yes" - stated to be the same as the predicate. The use of ASTM F560 compliant tantalum implies established radiographic visibility. |

Note: For 510(k) clearances, "acceptance criteria" are not always explicit performance thresholds like in a clinical trial. Instead, they are often about demonstrating that the modifications do not introduce new safety concerns or alter the fundamental technology such that the device is no longer substantially equivalent to a legally marketed predicate. The "study" described is primarily non-clinical: FMEA, FEA, and engineering rationale based on predicate comparisons.

Study Details from the Document:

Due to the nature of this 510(k) submission (a line extension with dimensional modifications), the "study" described is primarily non-clinical.

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

• Test Set Sample Size: Not applicable. No physical "test set" of devices was used for direct comparative bench testing in the provided summary for performance. The "test set" here refers to the new sizes and dimensional modifications themselves that were analyzed via FMEA, FEA, and engineering rationale.
• Data Provenance: The data provenance is internal engineering analysis and comparison to existing data/specifications of predicate devices. This is not external patient data (e.g., country of origin). The evaluation is based on component-level design and material properties. The analysis is prospective in the sense that it's evaluating the proposed changes before marketing, but it leverages retrospective data/knowledge from predicate devices.

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

• Number of Experts: Not specified. "Engineering rationale" implies input from qualified engineers or biomechanical experts within the manufacturer's team or consultants.
• Qualifications: "Quality and Regulatory Consultant" (Kellen Hills) and "Frank Morris (Alliance Partners, LLC)" are listed as contact persons. The FMEA and FEA would be conducted by engineers with relevant expertise (e.g., mechanical engineering, biomechanics). Specific qualifications are not detailed beyond their roles.

4. Adjudication Method for the Test Set:

• Not applicable as there was no independent clinical or expert review of a "test set" of cases. The assessment was internal through FMEA and FEA. This is a technical assessment rather than a clinical adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This type of study is for evaluating human performance influenced by a diagnostic aid (AI), which is not the nature of this interbody fusion device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI does not apply. The "standalone" performance here relates to the mechanical properties of the device itself, which were evaluated via FEA and engineering rationale, not algorithms.

7. The Type of Ground Truth Used:

• For the non-clinical assessment, the "ground truth" is a combination of:
  • Established mechanical properties and design specifications of the predicate devices.
  • Biomechanical principles and engineering calculations.
  • Regulatory standards (e.g., FDA's 2007 Special Controls guidance for Intervertebral Body Fusion Devices, ASTM F2026 for PEEK, ASTM F560 for Tantalum).
  • Clinical experience and safety profiles of the predicate devices (implied by their prior clearance and market use).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of an algorithm or AI system for a physical implant device submission like this. If we consider analogous concepts, the "training" for demonstrating substantial equivalence comes from the extensive historical data, design principles, and performance of existing predicate devices, which allows for leveraging FMEA/FEA rather than requiring de novo testing.

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

• Not applicable. As there is no training set as understood in AI/algorithm development, the concept of establishing ground truth for it doesn't apply. The device's "ground truth" (its safety and effectiveness claim) is based on its similarity to legally marketed devices whose safety and effectiveness have already been established through prior regulatory review and clinical use.

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The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.

The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from an anterior (ACIF) surgical approach. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

Here's an analysis of the provided text regarding the Alamo C device, focusing on the requested information:

Summary of Acceptance Criteria and Study Details for Alamo C

The provided text describes a 510(k) submission for the "Alamo C" intervertebral body fusion device. Crucially, this submission is for minor modifications (additional axial footprints) to an already cleared device. Therefore, the "study" described is a mechanical performance study to demonstrate that these modifications do not negatively impact the device's safety and effectiveness compared to the predicate device. This is not a clinical study involving human subjects or AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document only mentions "Performance testing" and "mechanical testing." For mechanical testing, this typically refers to a set number of physical samples of the modified device.
• Data Provenance: The data is generated from mechanical testing of the device itself (likely in a lab setting). It is not clinical data from human subjects and thus doesn't have a "country of origin" or "retrospective/prospective" designation in the typical sense for clinical studies.

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

• This question is not applicable as this is a mechanical performance study, not a clinical study that requires expert judgment for ground truth.

4. Adjudication Method for the Test Set

• This question is not applicable for a mechanical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is an intervertebral body fusion device, not an imaging or diagnostic AI tool that would typically undergo such a study.

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

• No, this question is not applicable. The Alamo C is a physical medical device (an implant), not an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this study is the established performance standards and criteria defined by ASTM F2077 for intervertebral body fusion devices. The device's performance is compared against these pre-defined mechanical requirements.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a mechanical test of a physical device, not an AI model.

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

• This question is not applicable. There is no ground truth for a training set in this context.

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The Alamo T is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

The Alamo T is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.

The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a transforaminal (TLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The provided text describes the "Alamo T" intervertebral body fusion device and its regulatory submission. It focuses on demonstrating substantial equivalence to predicate devices, primarily through design, material, and mechanical testing.

There is no information in the provided document about acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document describes a physical medical device (an intervertebral body fusion device) and its regulatory clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) rather than establishing novel performance criteria through clinical studies in the way an AI diagnostic tool might.

Therefore, I cannot populate the requested table and answer the study-related questions as they pertain to AI or software device performance acceptance criteria and validation.

Regarding the device described (Alamo T):

The closest equivalent to "acceptance criteria" for this type of device, as indicated in the document, would be its ability to perform comparably to its predicate devices in terms of mechanical properties and material composition.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to the physical device):

Regarding the study that proves the device meets the "acceptance criteria" (again, for the physical device):

The "study" or evidence provided is primarily mechanical testing and a demonstration of substantial equivalence to legally marketed predicate devices.

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

• Test Set (for mechanical testing): The document states "worst case device" was used for mechanical testing. It does not specify the exact sample size (e.g., number of devices tested for each mechanical test).
• Data Provenance: Not applicable in the context of patient data. The mechanical testing would have been conducted in a laboratory setting.

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

• Not applicable. Mechanical testing does not involve human expert ground truth. The "ground truth" is defined by the ASTM standards (F2077 and F2267) which specify the test methodologies and acceptable performance envelope for such devices.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are quantitative and do not require expert adjudication in the same way clinical data might. The interpretation of whether the results meet the ASTM standards and demonstrate substantial equivalence is a regulatory assessment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, often to assess the impact of AI assistance. This document describes a physical implantable device.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For mechanical performance: The "ground truth" is effectively the established performance thresholds and methodologies detailed in the ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices) and F2267 (Standard Test Method for Measuring Load-Displacement Properties of Intervertebral Body Fusion Devices) standards, against which the device's performance is compared to ensure it is within acceptable limits and comparable to predicates.
• For substantial equivalence: The ground truth is the performance characteristics and indications for use of the predicate devices (Globus Medical Signature TLIF Spacer (K072970) and Genesys Spine Interbody Fusion System (K103034)).

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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

• Not applicable, as there is no training set for this type of device.

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The Alamo P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a posterior approach.

The Alamo P is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a posterior (PLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The manufacturer conducted mechanical testing to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The submission states "worst case device" was used for mechanical testing. No specific sample sizes for repeat tests are provided. Given the nature of mechanical testing, samples would likely be manufactured in the country of origin of the device (not explicitly stated, but the contact person is in the US) and tested in a laboratory. This is a laboratory-based, prospective test.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This device is an intervertebral body fusion device and its performance is evaluated through mechanical testing, not through expert-labeled diagnostic data.

4. Adjudication Method for Test Set:

Not applicable. Mechanical testing does not involve human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical device, not an AI or diagnostic tool requiring human reader studies.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical device, not an algorithm. Its performance is assessed through its mechanical properties and structural integrity.

7. Type of Ground Truth Used:

The ground truth is based on the established engineering standards for intervertebral body fusion devices, specifically ASTM F2077 (Standard Test Methods for Static and Dynamic Axial Compression Fatigue Properties of Spinal Arthrodesis Implants) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression). The predicate device's performance against these standards serves as the benchmark for substantial equivalence.

8. Sample Size for Training Set:

Not applicable. This is a physical device, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable.

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The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.

The provided text is for a 510(k) premarket notification for a medical device called the "SwannShidi Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might find for novel AI-powered diagnostic devices.

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

Here's why and what information is provided:

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

• Not Applicable. The 510(k) process for this type of device does not typically involve pre-defined acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy. Instead, substantial equivalence is demonstrated by comparing the new device's design, materials, intended use, and operational principles to legally marketed predicate devices.

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 clinical test set data or studies are presented. The submission relies on a comparison table to predicate devices.

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. There is no test set or ground truth established in this type of submission.

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

• Not Applicable. No test set involved.

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 manual aspiration needle, not an AI-powered diagnostic tool. MRMC studies would not be relevant.

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

• Not Applicable. This device is a physical instrument, not an algorithm.

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

• Not Applicable. No ground truth needed as no diagnostic performance claim is being made.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device and therefore does not have a training set.

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

• Not Applicable. No training set.

What the document does provide in lieu of performance criteria and studies:

The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices. This is achieved by comparing various attributes of the SwannShidi Bone Marrow Aspiration Needle to its predicates:

• Intended Use: The SwannShidi is for "aspiration of bone marrow or autologous blood by use of a standard syringe." This is shown to be substantially equivalent to the predicates, which also involve bone marrow aspiration.
• Design Features: The device consists of a 15ga needle, angled tip stylet, depth gauge, locking mechanism, and a luer lock connection. These features are compared visually and descriptively to the predicates.
• Materials: Stainless steel for the needle/stylet and medical-grade plastic for plastic components are consistent with predicate devices.
• Sterilization Method: Ethylene Oxide is the chosen method, which is also consistent with predicates.
• Minor Technological Differences: The submission explicitly states, "The minor technological differences between the SwannShidi and its predicate devices raise no issues of safety and effectiveness."

Predicate Comparison Summary Table:

The table explicitly compares the SwannShidi to three predicate devices (Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle, H.S. Hospital Service BMN "I" Type Marrow Biopsy Needle, and Ranfac Goldenberg SNARECOIL Needle) across several criteria:

• Product Code: KNW (consistent for all except Ranfac which also lists FCG)
• Regulation Name: Gastroenterology-urology biopsy instrument (consistent across all)
• Intended Use: Similar for all, focusing on bone marrow aspiration/biopsy.
• Needle Size: 15 gauge (consistent with Busse and H.S.; Ranfac has a range including 15g)
• Stylet, Angled Tip, Male luer connection: All "Yes" and consistent with predicates.
• Material (Needle/Stylet, Plastic Components): Stainless Steel and Medical Grade Plastic, consistent with predicates.
• Sterilization Method: Ethylene Oxide, consistent with predicates.

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are effectively that the device is substantially equivalent in safety and effectiveness to existing legally marketed predicate devices, and the "study" demonstrating this is a direct comparison of features and intended use rather than a clinical performance study.

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