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510(k) Data Aggregation
(36 days)
ALLEZ SPINE, LLC
The LAGUNA® Size 8 Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (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); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
The LAGUNA® Size 8 Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Size 8 Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 35 mm to 100 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Size 8 Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
The provided text describes a medical device, the Allez Spine LAGUNA® Size 8 Pedicle Screw System, and its 510(k) premarket notification (K091995) to the FDA. The document focuses on the regulatory clearance process and includes information about the device's indications for use and equivalence to a previously marketed device.
However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The section "Performance data" states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This is a general statement and does not provide numerical acceptance criteria or detailed study results.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided document.
To summarize the requested categories:
- Table of acceptance criteria and reported device performance: Not provided in the text. The text only vaguely states "test results were equivalent to other similar implants and are sufficient for in vivo loading."
- Sample size used for the test set and data provenance: Not provided in the text.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no clinical study with expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this device is a physical spinal fixation system, not an AI or imaging diagnostic device. The concept of "human readers improve with AI vs without AI assistance" does not apply here.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used: Not explicitly stated for performance testing beyond "biomechanical tests."
- The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
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(73 days)
ALLEZ SPINE, LLC
The DEL MAR® Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (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); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion. The DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.
The DEL MAR® Monoaxial Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The DEL MAR® Monoaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
This K091219 document describes a spinal fixation system, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically in the context of AI/ML performance, cannot be extracted from the provided text.
The document discusses the Allez Spine Del Mar® Monoaxial Pedicle Screw System and focuses on its substantial equivalence to a predicate device based on material, design, and intended use for spinal fixation. The "Performance data" section (in {0}) states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates that the device's performance was evaluated through biomechanical testing to ensure it meets the mechanical requirements for spinal implants, but it does not involve any AI/ML components or associated acceptance criteria and study designs that would typically be described for such systems.
Therefore, I cannot provide the requested table and details as they pertain to AI/ML device performance.
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(30 days)
ALLEZ SPINE, LLC
The LAGUNA® Polyaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (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), spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The LAGUNA® Polyaxial Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case Multi axial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes All sizes are able to receive 5 5mm connecting rods only. The LAGUNA® Polyaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
This document describes the Allez Spine Laguna Polyaxial Pedicle Screw System, a spinal fixation system. However, the provided text does not contain acceptance criteria for specific performance metrics (like accuracy, sensitivity, or specificity) or detailed study results directly proving the device meets certain quantitative acceptance criteria in the way an AI/ML device submission would.
Instead, the submission focuses on substantial equivalence to a previously marketed predicate device and mentions general biomechanical tests.
Therefore, I cannot generate a table of acceptance criteria and reported device performance or answer most of the specific questions about clinical study design, as this information is not present in the provided 510(k) summary and FDA letter.
I can, however, extract what is mentioned regarding performance and study type:
Performance Data Mentioned:
- "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."
This statement indicates that the device underwent non-clinical performance testing (biomechanical tests) to demonstrate its mechanical properties and safety for its intended use. The acceptance criteria for these tests would typically involve meeting specific strength, fatigue, and other mechanical property thresholds established for similar spinal fixation devices. The specific thresholds are not provided in this summary.
Given the nature of the device (a physical medical implant, not an AI/ML diagnostic or predictive tool), the questions related to sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as they pertain to clinical or AI/ML performance evaluation studies.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical equivalence to similar implants and sufficiency for in vivo loading | "The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
| Material properties (per ASTM F136) | Components fabricated from "medical grade titanium alloy per ASTM F136." |
| Functional equivalence to predicate device | "substantially equivalent to the original Laguna® Pedicle Screw System" |
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 Provided. The document refers to biomechanical tests, not a clinical test set in the context of diagnostic accuracy. Biomechanical tests typically involve a defined number of device units tested under specific conditions to assess mechanical properties. The specific 'sample size' (number of units tested) is not provided, nor is the data provenance in this context applicable.
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 / Not Provided. This type of information is relevant for clinical studies involving expert interpretation, which is not described here for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. This is relevant for clinical studies with expert reviewers, not for biomechanical 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 is a physical implant device, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the biomechanical tests, the "ground truth" would be the engineering standards and specifications (e.g., ASTM F1717 for static and fatigue testing of spinal implant constructs, or similar standards relevant to pedicle screw systems) that define acceptable mechanical performance. The device's performance is measured against these established engineering standards.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, it's not an AI/ML algorithm.
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(285 days)
ALLEZ SPINE, LLC
The LAGUNA™ Spinal System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical pedicle fixation for the following conditions: degenerative disc disease (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); spinal stenosis; curvatures (i.e.scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The LAGUNA™ Size 8 Pedicle Screws are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine LAGUNA™ Polyaxial Pedicle Screw System. The LAGUNA™ Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine LAGUNA™ Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The LAGUNA™ Size 8 Pedicle Screws are available in eleven sizes ranging from 30 mm to 100 mm are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text describes a medical device, the LAGUNA™ Size 8 Pedicle Screw, and its clearance through the FDA 510(k) process. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML device evaluations.
The document primarily focuses on:
- Identifying the device and its manufacturer.
- Classifying the device and specifying its product codes.
- Describing the device and its intended use as an adjunct to fusion for various spinal conditions.
- Declaring substantial equivalence to a previously cleared device (LAGUNA™ Pedicle Screw System K050060).
- Mentioning that "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."
This is a regulatory filing for a physical medical implant (a pedicle screw), not an AI/ML-based diagnostic or therapeutic software device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.
Therefore, many of your requested fields will be filled with "Not Applicable" or similar, as the provided document pertains to a physical medical device and not an AI/ML-based system.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail metrics within this document (e.g., minimum tensile strength, fatigue cycles). | Biomechanical tests performed, results "equivalent to other similar implants" and "sufficient for in vivo loading." |
| Substantial Equivalence to predicate device (LAGUNA™ Pedicle Screw System K050060). | The FDA found the device substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document refers to "biomechanical tests" without detailing the number of units tested.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described generally as "biomechanical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, not an AI/ML system requiring expert ground truth for classification/detection. Performance is assessed through mechanical testing.
4. Adjudication method for the test set
- Not Applicable. Biomechanical tests typically involve laboratory measurements against engineering specifications, not 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
- Not Applicable. This is a physical device, not an AI/ML system for diagnostic assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used
- For biomechanical tests, the "ground truth" would implicitly be the established engineering standards and performance expectations for spinal fixation devices, as well as comparison to the predicate device's performance. There isn't a "ground truth" in the AI/ML sense (e.g., pathology, expert consensus).
8. The sample size for the training set
- Not Applicable. This is a physical device; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device; there is no "training set" or corresponding ground truth establishment process related to AI/ML.
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(115 days)
ALLEZ SPINE, LLC
The ALLEZ SPINE Cross Connectors are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The ALLEZ SPINE Cross Connectors are intended for posterior, non-cervical fixation in conjunction with the Allez Spine Laguna Pedicle Screw System for the following conditions: degenerative disc disease (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); spinal stenosis; curvatures (i.e.scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
The ALLEZ SPINE Cross Connectors are intended to help provide and Characteristics: correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The Laguna Spinal System consists of a variety of rods and screws. which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine Laguna Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The ALLEZ SPINE Cross Connectors are available in three sizes: small (37 mm), medium (50 mm) and large (80 mm) and are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text describes a 510(k) submission for the ALLEZ SPINE Cross Connectors. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through novel studies. Therefore, many of the requested elements are not applicable to a 510(k) summary focused on substantial equivalence.
Here's an analysis based on the provided text, highlighting where information is available and where it is not, or not relevant to this type of regulatory submission:
1. A table of acceptance criteria and the reported device performance
This information is not applicable in the context of a 510(k) summary that relies on substantial equivalence. A 510(k) submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, without necessarily establishing new, specific performance acceptance criteria beyond what is inherent in the predicate.
The document states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." However, it does not provide specific numerical acceptance criteria or the detailed results of these biomechanical tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable for device performance testing in a 510(k) submission focused on substantial equivalence. The "test set" and "data provenance" as implied in the question are typically relevant for clinical studies, which are not detailed or required for this type of submission.
The biomechanical tests mentioned would have their own sample sizes for the laboratory setups, but these are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The concept of "ground truth" and expert consensus is typically associated with clinical studies, especially those involving image analysis or diagnostic accuracy, which are not the focus of this 510(k) submission for a spinal fixation device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. An MRMC study is relevant for evaluating the performance of AI-powered diagnostic or decision support systems. The ALLEZ SPINE Cross Connectors are mechanical implants, not AI-driven diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question is relevant for AI algorithms. The device in question is a mechanical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the reasons mentioned in point 3. The primary "ground truth" in this context is the performance of the legally marketed predicate device, to which the new device is compared. For mechanical devices, performance is usually assessed through bench testing (e.g., fatigue, static loading) rather than clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The ALLEZ SPINE Cross Connectors are a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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(206 days)
ALLEZ SPINE, LLC
The LAGUNA™ Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (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); spinal stenosis; curvatures (i.e.scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
The Laguna™ Monoaxial Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.
The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The additional monoaxial screws are supplied in winged and non-winged configurations from 30 to 80 mm length and in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only.
The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text focuses on the 510(k) summary for the Allez Spine Laguna Monoaxial Pedicle Screw System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain details about acceptance criteria, a specific study proving those criteria, or information on AI/standalone algorithm performance, ground truth establishment, or multi-reader multi-case studies.
The document primarily states that:
- Performance Data: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."
This single statement is the extent of the performance data provided in this specific 510(k) summary. It does not elaborate on specific acceptance criteria, study methodologies, sample sizes, expert involvement, or AI aspects.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details as they are not present in the provided text.
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(113 days)
ALLEZ SPINE, LLC
The Laguna Spinal System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (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); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
The Laguna TM Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi axial implant screws are supplied in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text is a 510(k) summary for the Allez Spine Laguna™ Pedicle Screw System and a determination letter from the FDA. This document is for a medical device and therefore, the acceptance criteria and study information typically associated with AI/ML-based software (like those related to diagnostic performance or multi-reader studies) are not applicable.
Instead, the "performance data" section in this submission refers to biomechanical tests for the pedicle screw system, comparing its physical properties and mechanical strength to similar, already-approved implants. This is a common practice for hardware-based medical devices seeking 510(k) clearance via substantial equivalence.
Here's how to interpret the provided information in the context of a medical device submission, focusing on the available "performance data" section:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate device in biomechanical properties | "The test results were equivalent to other similar implants" |
| Sufficient for in vivo loading (implies adequate strength/durability) | "sufficient for in vivo loading" |
Explanation:
For a 510(k) submission based on substantial equivalence for a pedicle screw system, the "acceptance criteria" are not explicitly stated in numerical terms like sensitivity/specificity for AI, but are implied by the requirement to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device. This is typically shown through comparative biomechanical testing. The performance data states that the Laguna™ system's biomechanical test results were equivalent to other similar implants and sufficient for in vivo loading, thus meeting the implicit acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: This information is not provided in the document. Biomechanical testing typically involves a specific number of samples of the device components (e.g., screws, rods, constructs) tested under various loading conditions, but the exact number of components tested is not detailed here.
- Data Provenance: Not applicable in the human data sense. Biomechanical tests are laboratory-based studies performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth for biomechanical tests is established by engineering standards and measurements, not expert clinical interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Biomechanical tests are analytical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation software where human readers' performance with and without AI assistance is evaluated. This device is a surgical implant.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No, a standalone algorithm performance study was not done. This concept applies to AI/ML software; the device described is a physical implant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for biomechanical testing is based on engineering principles, material science standards (e.g., ASTM F136 or ISO 5832-3 or 5832-2 for materials), and established mechanical testing protocols. "Equivalence" is determined by comparing measured properties (e.g., strength, stiffness, fatigue resistance) against the predicate device's known performance or against accepted industry standards for spinal implants deemed sufficient for in vivo loading.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This concept applies to machine learning models, not physical medical devices undergoing biomechanical testing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
Summary in Context of the Device:
The Allez Spine Laguna™ Pedicle Screw System is a physical implant, not an AI/ML-based software. The "performance data" refers to biomechanical tests conducted to demonstrate that its physical properties and mechanical performance are equivalent to predicate devices already on the market, ensuring its safety and effectiveness for its intended use as an adjunct to spinal fusion. The acceptance criteria are therefore implicit in proving substantial equivalence through these physical tests as opposed to clinical or diagnostic performance criteria.
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