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The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• spinal tumor.
• pseudoarthrosis, and/or
• failed previous fusion.

The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis
• trauma (i.e., fracture or dislocation),
• spinal stenosis.
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• tumor,
• pseudarthosis, and/or
• failed previous fusion.

The UCR Spinal System includes titanium alloy polyaxial and polyaxial reduction screw assemblies. Both screw types will be offered in numerous widths and lengths. The screw assembly is comprised of a screw body, washer, and housing. Both screws are designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The UCR Spinal System will also include titanium alloy cross links, crossbars, rods, and caps. The cross links will come in one size, the crossbars in five sizes, the rods in two diameters, and the caps in two sizes. The cross link assemblies are comprised of a nut and hook while the crossbar assemblies are made up of two bars, two locking screws, a coupler, and a pin. All of these devices are designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The UCR Spinal System will offer a wide variety of instruments that range from in-situ rod benders to modular taps. These various instruments will be made primarily from various grades of stainless steel with a few components made from aluminum, titanium alloy, Radel, and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.

The provided document is a 510(k) summary for the UCR Spinal System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information you've requested regarding acceptance criteria, study details, expert involvement, and ground truth is generally not applicable in the context of this 510(k) submission.

Here's why and what information is available:

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

• Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating that the new device shares the same fundamental scientific technology, has the same intended use, and is as safe and effective as a legally marketed predicate device. Specific quantitative performance metrics (like sensitivity, specificity, accuracy for an AI device) and their acceptance thresholds are typically not established or reported in this format. The primary acceptance criterion here is "Substantially Equivalent."
• Reported Device Performance: The document states that the new components of the UCR Spinal System are "Substantially Equivalent" to the current UCR Spinal System (predicate device) in terms of Intended Use, Indications for Use, Design, Screw Sizes, Cross Links, Crossbars, Rods, Caps, Material, Sterilization, and Method of Sterilization. For "Mechanical Strength," it states "See test results," implying that testing was done to ensure the mechanical properties are similar to the predicate, thus meeting the substantial equivalence requirement.

Table of Acceptance Criteria and Reported Device Performance (based on provided text):

The remaining points are largely not applicable because this is a 510(k) for a physical medical device (spinal system components), not an AI/software device or a clinical study establishing new performance benchmarks.

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

• Not Applicable. This document describes a submission for a physical implantable device (UCR Spinal System components). The "test set" in this context would refer to mechanical testing of the physical components, not a dataset of patient images or clinical data for an AI algorithm. The document states "See test results" for mechanical strength, indicating such testing was performed, but specific sample sizes and data provenance for these engineering tests are not detailed 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)

• Not Applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or image interpretations, is not relevant for a 510(k) submission for a physical spinal implant. "Ground truth" for this device would relate to engineering specifications and material properties, validated by standard mechanical testing protocols (e.g., ASTM standards), not medical experts.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in radiological reads for AI studies). This is not relevant for mechanical testing of a medical device.

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

• Not Applicable. MRMC studies are specifically for evaluating diagnostic accuracy with and without AI assistance in situations involving medical image interpretation. This submission is for a physical orthopedic 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 device is a physical implant, not a standalone AI algorithm.

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

• Not Applicable. As mentioned, "ground truth" for this device would be derived from physical and mechanical performance specifications and testing results, confirming that the new components meet established engineering standards and are substantially equivalent to the predicate device. It would not typically involve medical "ground truth" like pathology or outcomes data in the context of a 510(k) for device components.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are relevant for machine learning algorithms.

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

• Not Applicable. There is no training set or associated ground truth for this type of device submission.

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The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:

• The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
  The intended use and indications when used as a Pedicle Screw Spinal System are:
• The UCR Spinal System is a pedicle screw system 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:
• degenerative spondylolisthesis with objective evidence of neurological impairment,
• fracture,
• dislocation,
• scoliosis,
• kyphosis,
• spinal tumor, and
• failed previous fusion (pseudoarthrosis).
  The indications for use as a Hook Spinal System are limited to T1-L5 and are:
• degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic),
• spinal stenosis,
• spondylolisthesis,
• spinal deformities (scoliosis, kyphosis, and/or lordosis),
• fracture,
• pseudarthosis,
• tumor resection, and/or
• failed previous fusion.

The UCR Spinal System cross links and their components include variable and fixed cross links, fixed cross link bars, link bars, rounded links, screws, coupler, and an instrument. The variable cross links will be available in sizes ranging from 23 to 75mm and the fixed cross links and fixed cross link bars in sizes between 20 and 36mm. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The provided text is a 510(k) summary for the UCR Spinal System, specifically focusing on its cross links. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device efficacy through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and comparative effectiveness are not applicable or not detailed in this document.

However, I can extract the information relevant to acceptance criteria in the context of a 510(k) (i.e., comparison to the predicate device) and provide available details about the comparative study conducted.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission like this, "acceptance criteria" for substantial equivalence are generally met by demonstrating that the new device has the same technological characteristics, intended use, and indications for use as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. Mechanical testing is typically performed to demonstrate equivalent performance.

Note: The "acceptance criteria" here are defined by the predicate device's characteristics and the requirement for "substantial equivalence." The "reported device performance" is the comparison against those characteristics.

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

The document refers to mechanical strength testing ("See test results"), but does not specify the sample size (number of devices tested) for these mechanical tests, nor does it provide data provenance (e.g., country of origin, retrospective/prospective nature) for any specific testing data. Mechanical testing in a 510(k) is typically conducted in a lab environment.

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

This information is not applicable to this 510(k) submission. No clinical study with expert-established ground truth is described or referenced. The "ground truth" for a 510(k) for a device like this relies on engineering principles and comparison to the predicate device's established performance.

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

Not applicable. No expert adjudication process for a test set 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 a medical device for spinal fixation, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted or is relevant to this submission.

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

Not applicable. This is a physical implantable device, not an algorithm.

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

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:

• The established intended use and indications for use of the predicate device.
• The design, material, and dimensional specifications of the predicate device.
• Mechanical engineering principles and testing standards to ensure that the new device's mechanical strength is comparable to the predicate.

8. The sample size for the training set

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

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

Not applicable, as there is no training set.

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The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:

• The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The intended use and indications when used as a Pedicle Screw Spinal System are:

• The UCR Spinal System is a pedicle screw system 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:
• degenerative spondylolisthesis with objective evidence of neurological impairment,
• fracture,
• dislocation,
• scoliosis,
• kyphosis,
• spinal tumor, and
• failed previous fusion (pseudoarthrosis).

Hook Spinal System indications are limited to T1-L5 and are:

• degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic),
• spinal stenosis,
• spondylolisthesis,
• spinal deformities (scoliosis, kyphosis, and/or lordosis),
• fracture,
• pseudarthosis,
• tumor resection, and/or
• failed previous fusion.

The UCR Spinal System hooks include titanium alloy laminar and pedicle hook assemblies. The laminar hooks will be available in widths of 5.5mm and 7.0mm and in five heights that range from 5.0 to 10.0mm. The pedicle spinal hooks will be available in widths of 7.5mm and 9.0mm and in four heights that range from 5.0 to 9.5mm. The laminar hooks will also be available in offset versions. The hook assembly is comprised of a hook body, temporary fixation pin, cap, and set screw. The hook assembly is designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The UCR Spinal System hooks also utilize a variety of instruments to assist in placement of the devices. These instruments include a hook holder, hook inserter, temporary fixation pin inserter, power rod gripper, and a rocker. The instruments will be fabricated from stainless steel and Radal. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The provided text describes the UCR Spinal System, focusing on its intended use, description, and technological characteristics compared to predicate devices. It clearly states that the device is "substantially equivalent" to existing predicate devices.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics.

The text is a 510(k) summary, which is typically a premarket notification to the FDA. For devices like the UCR Spinal System, substantial equivalence to a legally marketed predicate device is the primary pathway for clearance, rather than extensive performance studies with acceptance criteria as would be required for a novel, high-risk device or a diagnostic algorithm.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on intended use, design, dimensional specifications, and material to predicate devices, rather than presenting a performance study against specific acceptance criteria.

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1. Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
   The HAIDER-UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
2. Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
   The HAIDER-UCR Spinal System is a pedicle screw system 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:

• degenerative spondylolisthesis with objective evidence of neurological impairment,
• fracture,
• dislocation,
• scoliosis,
• kyphosis,
• spinal tumor, and
• failed previous fusion pseudarthrosis)

The new 5.5mm screw will be used in all UCR Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical properties and fatigue performance are important. The remainder of the UCR Spinal System components will remain unchanged. Other than the major and minor diameter of the cancellous portion of the shaft and threads, the new 5.5mm screws are similar to the existing screws. Spinal rod attachment method are the same as cleared previously.

The new 8.0mm Spinal Screws expand the options for screw insertion by providing an alternative to the smaller 6, 6.5 or 7.0mm pedicle screws of the available UCR Spinal System. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the large size of the pedicle makes use of smaller diameter screws less desirable. The larger diameter of the 8.0mm Spinal Screws permits the surgeon to address the needs of an expanded patient population.

The provided document is a 510(k) Premarket Notification for the UCR Spinal System, specifically focusing on new 5.5mm and 8.0mm spinal screws. This document addresses the substantial equivalence of these new components to previously cleared devices.

Based on the provided information, the device is a pedicle screw Spinal System, which falls under Class II uses. The "studies" conducted are non-clinical bench tests focused on mechanical and fatigue performance to ensure the new screws meet established standards and are equivalent to the predicate device.

Here's an analysis of the requested information:

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

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

• Sample Size for Test Set: The document does not specify the exact number of samples tested for the mechanical and fatigue testing. It only states "Samples were tested".
• Data Provenance: The data provenance is from non-clinical bench testing. The testing was conducted by SEASPINE, INC. The country of origin of the data would be the USA, where SEASPINE, INC. is located. It is prospective in the sense that the testing was performed specifically for this 510(k) submission, not gathered retrospectively from patient 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 a non-clinical mechanical testing study, not a clinical study involving diagnosis or interpretation by medical experts. Therefore:

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

The "ground truth" here is the performance under defined mechanical engineering standards, which is established by the test methods themselves and interpreted by engineers.

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

Since this is a non-clinical mechanical test, an adjudication method for human interpretation is not applicable. The results are quantifiable mechanical measurements.

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

• MRMC Study: No, an MRMC study was not done. This submission is for a medical device (spinal screws), not an AI/software device that assists human readers.
• Effect Size: Not applicable.

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

• Standalone Performance: No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device.

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

The ground truth used for this premarket notification is based on engineering standards and mechanical performance metrics. Specifically, the ability of the screws to "carry clinically useful loads out to the five-million cycle asymptotic endurance limit" as defined by the ASTM F-1717-96 guidance document.

8. The sample size for the training set

This is a non-clinical mechanical testing study for a physical device. There is no "training set" in the context of machine learning or AI. The tests are designed to validate the physical properties against established standards.

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

As there is no training set, this question is not applicable. The "ground truth" for the device's performance is established by the specified mechanical testing methods and standards (e.g., ASTM F-1717-96).

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