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510(k) Data Aggregation
(29 days)
Infinity OCT System and PASS OCT Spinal System
The Infinity™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- Failed previous fusions (e.g. pseudarthrosis).
- Tumors involving the cervical spine.
- Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT Rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and VertexTM Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert and Vertex™ Reconstruction System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) reguires the use of MAS Crosslink™ at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offiset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
The PASS OCT spinal system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT spinal system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.
The Infinity™ OCT System and PASS OCT Spinal System (including UNID™ OCT Patient-Specific Rods) are posterior systems, which consist of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537.
The purpose of this submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNID™ OCT Patient-Specific Rods. The subject rods are designed and manufactured for one specific patient and are compatible with Infinity™ OCT System and PASS OCT Spinal Systems (cranially) and the CD Horizon Spinal System (caudally). The UNID™ OCT Patient-Specific Rods must be used during surgery for this patient only and must not be reused (single use only).
This document describes a spinal system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI/ML models is not applicable and cannot be extracted from the provided text.
The document pertains to the 510(k) premarket notification for the "Infinity™ OCT System and PASS OCT Spinal System," which are posterior cervical screw systems intended to provide immobilization of spinal segments. The purpose of the specific submission is to add titanium alloy and cobalt chrome 3.5/4.75 mm transition rods to the line of UNiD™ OCT Patient-Specific Rods.
The "Performance Data (Non-Clinical Test Summary)" section mentions that "Medicrea has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices." The tests performed were "static and dynamic compression bending, and static torsion" per ASTM F1717, to confirm the compatibility of the caudal 4.75 mm portion of the subject rods with the CD Horizon Spinal System. This describes mechanical testing of a medical device, not a study of an AI/ML algorithm.
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(77 days)
PASS OCT Spinal System
The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods or dominos. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.
The PASS OCT Spinal System is a posterior system. which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.
The purpose of this 510(k) submission is to add offset connectors to the PASS OCT Spinal System.
This FDA 510(k) summary describes a spinal implant system, not an AI/ML powered device. Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance are not applicable.
However, I can extract the relevant information regarding the non-clinical testing performed for this medical device.
Device Name: PASS OCT Spinal System (specifically, additional components including offset connectors)
Device Type: Spinal implant system, specifically a posterior system for immobilizing spinal segments as an adjunct to fusion.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance for the additional components (offset connectors). However, it refers to the standard used for mechanical evaluation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance meeting requirements of ASTM F1798 (Implied: adequate strength and fatigue resistance for spinal implants) | The subject components (offset connectors) of the PASS OCT spinal system were mechanically evaluated in axial and torsional grip and dynamic flexion-extension per ASTM F1798. (This indicates the tests were performed and presumably met the standard, otherwise it would likely not be cleared.) |
| Biocompatibility requirements met (Implied: non-pyrogenic) | Pyrogenicity testing was conducted in support of PASS OCT component substantial equivalence. (This indicates the test was performed and presumably met the standard.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of number of devices tested. Mechanical testing typically involves a statistically relevant number of samples, but the exact count is not provided here.
- Data Provenance: Not applicable in the context of human data. The testing is non-clinical (bench testing), performed on the device components themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a non-clinical, bench testing study. "Ground truth" does not apply in the context of expert consensus for interpretations as it would for imaging or diagnostic AI. The "ground truth" for mechanical testing is established by the test methods and acceptance limits defined in the ASTM F1798 standard.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are relevant for human interpretation tasks, not for mechanical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a non-clinical bench study of a spinal implant, not an AI/ML diagnostic or assistive device for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the non-clinical mechanical testing, the "ground truth" is defined by the specifications and requirements of the ASTM F1798 standard (Standard Practice for Testing Impact-Resistant Spinal Fracture Reduction Systems components in axial and torsional grip and dynamic flexion-extension). The pyrogenicity testing would adhere to established standards for biocompatibility.
8. The Sample Size for the Training Set:
Not applicable. There is no training set as this is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device.
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(39 days)
PASS OCT Spinal System
The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods or dominos. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.
The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the PASS OCT Spinal System:
The provided document is a 510(k) summary for additional components to the PASS OCT Spinal System. It does not contain information about the acceptance criteria for the device's clinical performance, nor does it detail a study that proves the device meets specific clinical performance acceptance criteria. This document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, materials, and mechanical performance.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The document describes the system components and their intended use, but it does not specify quantitative clinical acceptance criteria (e.g., success rates, complication rates, or functional outcomes) or report on specific clinical performance against such criteria. The document explicitly states: "No clinical data or published literature were used to demonstrate substantial equivalence."
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document states "No clinical data or published literature were used to demonstrate substantial equivalence." Therefore, there was no clinical test set for which a sample size or data provenance would be reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As no clinical study or test set data was used, no experts were needed to establish ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set.
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/Not provided. This device is a spinal implant system, not an AI-driven diagnostic or assistive device for human readers. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a spinal implant system, not an algorithm or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. As no clinical data was used to demonstrate substantial equivalence, there was no ground truth established for this submission. The "truth" for this submission hinges on demonstrating substantial equivalence to predicate devices through comparison of design, materials, and mechanical testing, rather than clinical outcomes.
8. The sample size for the training set
The document refers to mechanical testing as a "Non-clinical Test Summary." It mentions that "The components of the PASS OCT spinal were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F2706-08."
- Training Set Sample Size: The sample size for this non-clinical testing is not specified in the provided text.
- How ground truth for training set was established: The "ground truth" for non-clinical mechanical testing would be the compliance with pre-defined engineering and material standards (e.g., ASTM F2706-08 for mechanical properties, ISO and ASTM standards for material specifications). This is established by engineering and materials science principles and testing procedures.
9. How the ground truth for the training set was established
For the non-clinical tests, the "ground truth" is established by the specified ASTM and ISO standards for mechanical testing and material properties. The device components are tested to confirm they meet the strength, durability, and material composition requirements outlined in these recognized standards, which are considered objective measures of performance for this type of device.
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(193 days)
PASS OCT Spinal System
The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the PASS OCT Spinal System may be connected to the PASS LP Spinal System rods with the dual diameter rods. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.
The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.
The provided document is a 510(k) premarket notification for a medical device called the "PASS OCT Spinal System." This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as one might find for novel drug or high-risk device approvals.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment is largely not present in this type of FDA submission. The provided text primarily addresses material specifications, intended use, and comparison to predicate devices, along with some mechanical testing information.
Here's an attempt to answer your questions based only on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for the device itself or reported performance outcomes in terms of clinical efficacy or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the same implicit performance standards.
The only "performance" mentioned is in the "Non-clinical Test Summary":
| Acceptance Criteria (Implicit) | Reported Device Performance (as tested) |
|---|---|
| Mechanical integrity under dynamic compression, conforming to ASTM F2706-08 | "mechanically evaluated in dynamic compression tests following the ASTM F2706-08." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For the non-clinical mechanical testing, the sample size is not specified. The provenance is also not specified, beyond the fact that Medicrea International S.A. is based in France. This was a non-clinical, in-vitro test, 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)
This is not applicable as the described "study" is a non-clinical mechanical test, not a study involving human subjects or requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the described "study" is a non-clinical mechanical test that does not involve 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
The document explicitly states: "No reference devices were used in this submission." and later, under "8. Clinical Test Summary": "Published literature was used to demonstrate substantial equivalence." This indicates that neither a clinical trial nor an MRMC study was conducted by the applicant for this submission. The device is a spinal implant, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a spinal implant, not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance requirements outlined in the ASTM F2706-08 standard. It's a pass/fail against established mechanical properties, not a biological or clinical ground truth.
8. The sample size for the training set
This is not applicable. No training set is mentioned as this is a medical device approval and not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable. No training set is mentioned.
Summary of what is available from the document regarding acceptance criteria and studies:
- Acceptance Criteria for Device (Implicit): Substantial equivalence to predicate spinal systems (Vertex Reconstruction System, Virage OCT Spinal Fixation System, and a previous version of the PASS OCT Spinal System). This implies meeting the safety and performance characteristics of those already cleared devices.
- Specific Performance Criterion (Mechanical): Conformity to ASTM F2706-08 for dynamic compression tests.
- Study: A non-clinical, in-vitro mechanical evaluation.
- Sample Size (Mechanical Test): Not specified.
- Clinical Data: No new clinical studies were conducted by the applicant. Substantial equivalence was demonstrated through comparison to legally marketed predicate devices and reliance on published literature (though the specific literature isn't detailed).
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(258 days)
PASS OCT SPINAL SYSTEM
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:
- Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Trauma (i.e. Fracture or Dislocation)
- Atlanto/axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
Occipital Plates / Occipital Bone Screws / Hooks:
The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
Hooks and rods:
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Polyaxial screws/Connectors:
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.
The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.
The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.
Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|
| Multi-axial screws & Rods Constructs | |
| Static Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Static Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Occipital Plates, Occipital Screws & Dual Diameter Rod Constructs | |
| Static Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Compression (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Static Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
| Dynamic Torsion (ASTM F2706-08 / Guidance of Spinal System 510(k)s) | Substantially Equivalent to predicate devices (SUMMIT System (K002733), Mountaineer OCT Spinal System (K042508), Vertex Reconstruction System (K052734), PASS 2 Spinal System (K062136)) in terms of mechanical safety and performance. |
Study Details
- Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by mechanical testing standards, not expert clinical interpretation.
- Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
- The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.
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