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EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EOVIA Calcium Phosphate Ceramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.

EOVIA is a synthetic, resorbable calcium phosphate bone void filler. It is an osteoconductive material, which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range between 200-500μm. EOVIA is available in granule or rods shapes.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the EOVIA™ Calcium Phosphate Ceramic, detailing its description, intended use, materials, and a declaration of substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample size, data provenance, expert qualifications, adjudication method, MRMC study details, standalone performance, ground truth type, or training set information.

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ORIA Top Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Top Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Top Clip System includes components made from commercially pure titanium and titanium alloy described by ASTM Standards F67 GR2 and ASTM F136, respectively. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle screws, set screws, top locking clips and rods.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the ORIA Top Clip System, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. It describes the device, its intended use, materials, and states that substantial equivalence is based on fundamental scientific technology and indications/intended use.

Therefore, I cannot provide the requested table and information about a study from the given text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing equivalence, not specific performance metrics against defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: No test set is mentioned, as no study demonstrating performance is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no "test set" or ground truth establishment study described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: lumbar, thoracic, and pedicular hooks; sacral screws; pedicle screws; set screws; locking nuts; rods in various lengths; connectors with set screws (sacral, transverse, lateral); connecting elements; instruments and sterilizer trays.

This 510(k) summary for the ORIA Spinal Clip System does not contain information commonly found in a study proving a device meets acceptance criteria for an AI/ML medical device. Instead, it is a submission for a traditional medical device (spinal clip system) focusing on demonstrating substantial equivalence to previously cleared devices.

Therefore, many of the requested points related to acceptance criteria and study design for an AI/ML device simply aren't applicable or available in this document.

Here's an analysis based on the provided text, highlighting what can be extracted and what is not present:

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

• Acceptance Criteria (Implicit): Substantial equivalence in indications for use, anatomic sites, design, material of manufacture, and function compared to predicate devices.
• Reported Device Performance: The document states that "Documentation was provided which demonstrated the ORIA Spinal Clip System Domino and Tube Connectors to be substantially equivalent to previously cleared devices." No specific performance metrics (e.g., strength, durability, biocompatibility) are provided in this summary, but rather a general statement of equivalence.

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 provided as this is a mechanical device submission, not an AI/ML algorithm submission. There is no "test set" in the context of an algorithm's performance evaluation. The "data" here would be the physical testing of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable for a mechanical device submission. There is no concept of "ground truth" established by experts for performance in this context.

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

• This information is not applicable for a mechanical device submission.

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

• This information is not applicable as this is not an AI-assisted device.

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

• This information is not applicable as this is not an AI device.

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

• This information is not applicable for a mechanical device. The "ground truth" for a mechanical device typically involves engineering specifications, material standards (e.g., ASTM F136, F138), and performance testing according to recognized standards (e.g., fatigue testing, pull-out strength). However, the specific details of these tests are not included in this summary.

8. The sample size for the training set

• This information is not applicable as this is not an AI/ML device.

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

• This information is not applicable as this is not an AI/ML device.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving device performance against specific acceptance criteria through a clinical study or a standalone algorithm evaluation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because it primarily describes the device, its intended use, and its substantial equivalence to a predicate device. Clinical performance data, often generated through detailed studies with specific acceptance criteria, are typically found in more comprehensive clinical sections of a PMA (Premarket Approval) or sometimes in 510(k) de novo submissions, but are not explicitly detailed in this summary.

Here's an attempt to populate the table and answer the questions based on the type of information present in a 510(k) summary, rather than a clinical trial report:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary focused on substantial equivalence, explicit "acceptance criteria" for device performance in a clinical study context and corresponding "reported device performance" are not typically presented in the way they would be for a novel device undergoing extensive clinical trials or an AI/ML algorithm. Instead, the "performance" demonstrated for substantial equivalence is primarily based on equivalence in design, materials, and function to a predicate device.

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 510(k) summary does not describe a "test set" in the context of a clinical study or algorithm evaluation. The substantial equivalence determination is based on a comparison to a predicate device's existing regulatory clearance and established performance, not new clinical data specific to the ORIA Spinal Clip System detailed in this document.
• Data Provenance: Not provided, as no specific test set data is mentioned.

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: No "ground truth" for a test set is described, as no clinical study data is presented. The determination of substantial equivalence relies on regulatory review and comparison by FDA experts to existing cleared devices.

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

• Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set or clinical study requiring one.

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 mechanical spinal implant system, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

• Not Applicable / Not Provided: This device is a mechanical spinal implant system, not an algorithm. Standalone performance for an algorithm is not relevant or described.

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

• Not Applicable / Not Provided: No "ground truth" is established or discussed as no new clinical performance data from a specific study is presented for the ORIA Spinal Clip System itself in this summary. The "ground truth" for showing safety and effectiveness is largely based on the predicate device's established performance and regulatory clearance.

8. The sample size for the training set

• Not Applicable / Not Provided: No "training set" is applicable or described, as this is a mechanical device, not an AI/ML system.

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

• Not Applicable / Not Provided: No "training set" or method for establishing its ground truth is applicable or described.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, primarily through comparison of indications for use, anatomic sites, design, materials, and function, rather than through performance metrics for an AI algorithm.

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MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:

• having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
• receiving fusions using autogenous bone graft only; .
• having the device fixed or attached to the lumbar and sacral spine; and
• . having the device removed after the development of a solid fusion mass.

MNI - Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T-10 - S1/2):

• degenerative spondylolisthesis with objective evidence of neurologic impairment .
• fracture
• dislocation
• . scoliosis
• kyphosis
• . spinal tumor
• failed previous fusion (pseudarthrosis) .

The ORIA CLARIS includes implantable components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system to fit the patient's individual anatomical and physiological requirements. Selection of the necessary components is addressed in the surgical protocol. The titanium components are made of surgical implant grade CP Titanium and titanium alloy (6al4Vti). The basic system components include: Connectors, Nuts & Locking Screws, Rods, Crosslinks, Pedicle Screws, Sacral Screws, Unique Instrumentation. The system consists of a series of alloy compatible parts from which various spinal assemblies or constructs may be fashioned. Specially designed connectors, interconnection mechanisms incorporating nuts, screws; longitudinal members (rods) and/or transverse connectors, sacral screws and pedicle screws are offered. The levels of attachment (depending on specific indication) are lumbar and thoracic spine, and the sacrum and may only be used posteriorly.

This appears to be a 510(k) premarket notification for a medical device (ORIA CLARIS Posterior spine system). The provided document describes the device, its indications for use, and regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for performance studies of AI/diagnostic devices.

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Eurosurgical, S.A., K021679) for regulatory approval, rather than presenting a performance study with specific acceptance criteria and detailed methodology using a test set, ground truth, experts, etc.

Therefore, I cannot populate the table or provide the requested information because the provided text does not contain:

• Explicit acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• A "study" in the sense of a clinical trial or a performance evaluation against a defined ground truth on a test set. The closest it comes to "testing" is mentioning compliance with material, mechanical, and biocompatibility standards, and sterilization cycle validation, but these are not performance studies as typically described for AI/diagnostic devices.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (beyond general material/mechanical standards).
• Sample size for a training set.
• How ground truth for a training set was established.

The document's purpose is to satisfy regulatory requirements for market clearance based on substantial equivalence to an existing device, which often relies on demonstrating similar design, materials, and intended use, rather than novel performance benchmarks.

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When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks: Sacral screws: Pedicle screws: Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It details the device's intended use, materials, and substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based only on the provided text.

The document focuses solely on establishing substantial equivalence for regulatory clearance, which typically relies on comparisons to predicate devices and adherence to relevant standards, rather than new multi-reader comparative effectiveness studies or detailed performance metrics.

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The ORIA ZENITH is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

WARNING: The ORIA ZENITH is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The ORIA ZENITH is a cervical plate system consisting of plates and screws manufactured from titanium alloy (ASTM F 136). Plates are available in a variety of lengths. Fixed and variable screws are available in a variety of lengths and diameters of 4.0 and 4.5mm. A self-tapping version of each screw is also available.

The provided text is a 510(k) summary for the ORIA ZENITH cervical plate system. It describes the device, its intended use, materials, and substantial equivalence to a previously cleared device. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies.

The 510(k) summary focuses solely on demonstrating substantial equivalence to a predicate device based on design, materials, manufacturing, and intended use. There is no performance data or study results included.

Therefore, I cannot populate the requested table and answer the specific questions about device performance and studies based on the provided text.

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Ask a specific question about this device

When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria and outcome metrics. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study methodologies common in AI/Diagnostic device approvals are not present in this document.

However, I can extract the information that is available and explain why other details are missing.

Here's the analysis based on the provided text:

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

Explanation of Table Details: The "acceptance criteria" here are implied by the 510(k) process for substantial equivalence. For a 510(k) submission, the primary "acceptance criterion" is that the new device is "substantially equivalent" to a legally marketed predicate device. This is evaluated across various aspects like intended use, technology, materials, and safety/effectiveness. The document states that "Documentation was provided which demonstrated the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to be substantially equivalent..." based on these factors. No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical stress test results with defined pass/fail thresholds) are explicitly stated in this summary as "acceptance criteria."

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

• Sample Size: Not applicable/Not mentioned. This document describes a 510(k) for a spinal implant system, not a diagnostic or AI device that typically uses a "test set" of patient data for performance evaluation. The "study" here is a substantial equivalence comparison to a predicate device.
• Data Provenance: Not applicable/Not mentioned.

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

• Not applicable/Not mentioned. No "test set" requiring expert ground truth is described.

4. Adjudication method for the test set

• Not applicable/Not mentioned. No "test set" requiring adjudication is described.

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

• Not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

• Not applicable. This is not an AI or algorithm-based device.

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

• The "ground truth" in a 510(k) for a device like this is the established safety and effectiveness of the predicate device. The new device leverages this by demonstrating substantial equivalence. The document doesn't detail performance studies of the device itself, but rather its similarity to an already approved device.

8. The sample size for the training set

• Not applicable/Not mentioned. This device does not involve machine learning or a "training set."

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

• Not applicable/Not mentioned. This device does not involve machine learning or a "training set."

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this context is the submission of documentation to the FDA to demonstrate substantial equivalence of the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to a previously cleared predicate device, the OmniAxial Connector (CO04).

• Methodology: The manufacturer provided documentation comparing the new device components to the predicate device across several key attributes.
• Proof of Meeting Criteria: The FDA's letter (K030252) confirms that based on the submitted information, the device is determined to be "substantially equivalent." This means the FDA accepted the manufacturer's provided documentation as sufficient proof that the new device meets the implied "acceptance criteria" of being comparable to the predicate device in terms of:
  • Indications/Intended Use
  • Manufacturing Methods
  • Interconnection (attachment) mechanism
  • Basic Design
  • Materials (Titanium alloy ASTM F136-98)

This type of 510(k) summary typically does not include raw performance data, clinical trial results, or detailed statistical analyses that would be found for novel devices or AI/diagnostic systems. It focuses on the comparison to an already approved product.

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