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The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion.

The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal system is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the Ø5.5mm to Ø6.0mm Radius® rod-to-rod connector.

The Stryker Spine TRIO® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The Stryker Spine TRIO® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine TRIO® Spinal Fixation System is indicated for: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® Spinal Fixation Sytem is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segements in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The TRIO® + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors.

The Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc Disease (DD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion.

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DDD) (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; Pseudoarthrosis and; Failed previous fusion. The 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (DDD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor, Pseudoarthorisis; and Failed Pervious Fusion. The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DD) (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthorisis; and Failed Pervious Fusion. The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The STRYKER Spine thoraco-lumbar spinal fixation systems, subject of this 510(k), are non-cervical, pedicle and non-pedicle fixation systems comprised of screws, rods, plates, hooks, connectors, washers and staples. The components are manufactured from either Titanium (Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®). This Special 510(k) submission seeks clearance for sterile labeling of the listed STRYKER Spine thoraco-lumbar spinal fixation systems. All of the components of the subject devices will be sterilized by gamma radiation, a traditional sterilization method as per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.

This is a 510(k) Premarket Notification for sterile packaging of a range of spinal systems. The key claim is substantial equivalence to previously cleared non-sterile versions of the same devices. Therefore, the "device" in question for this submission is specifically the sterile packaging and the sterilization process, not the spinal implant itself as a medical device performing a physiological function. The "performance" being evaluated is the ability to maintain sterility and the structural integrity of the device within its packaging over its shelf life.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document primarily discusses the sterilization process and packaging rather than clinical performance of the implant itself. Therefore, typical "test set" in the context of clinical or diagnostic AI/software devices (e.g., patient data) is not applicable here.

• Sterilization and Packaging Validation Data: The document mentions "accelerated aging data" for validating the 5-year shelf life. It does not specify the sample size for this testing, nor the country of origin or whether it was retrospective or prospective. However, these types of tests are typically prospective laboratory studies conducted in controlled environments.

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. This submission is about the sterility and packaging of medical implants, not a diagnostic or clinical performance study that would require expert ground truth labeling. The "ground truth" here is the scientific validation of sterilization methods and shelf life according to recognized standards and FDA guidance.

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

Not applicable. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not relevant to this submission on sterile packaging.

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/software device and no MRMC study was conducted.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this submission relies on:

• Scientific Validation of Sterilization: Adherence to established scientific principles and FDA guidance for sterilization (gamma radiation), demonstrating a Sterility Assurance Level (SAL).
• Accelerated Aging Data: Laboratory testing to simulate real-time aging and demonstrate that the sterile barrier packaging system maintains sterility for the stated shelf life.
• Material and Design Specification Conformity: Confirmation that the components are manufactured from specified materials and that their design, technical requirements, and intended use are identical to the non-sterile predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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The AEGIS and AEGIS II Spinal 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, The AEGIS I and AEGIS II Spinal Systems are indicated for patients with deqenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, turnor, pseudoarthrosis, or revision of failed fusion attempts.

The AEGIS® Pedicle Screw System is comprised of pedicle screw with diameters from 4.5mm to 8.5mm with increments of 1mm and length ranging from 20mm to 55 mm with increments of 5mm, a sleeve of standard diameter of 14 mm, and a set screw of M10XP1.0 & rods with standard diameter of 6 mm. All the components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The mono axial pedicle screw is used as an adjunct to spinal fusion surgery, provides a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments (e.g. lumbar segment 4 and 5) and then a short rod is used to connect the screws. This construct prevents motion at the segments that are being fused.

The Corentec® AEGIS II® Spinal system consists of various Pedicle Screws (mono / poly) with standard and guided type designs, Rod and Rod Link with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. This system is designed on the basis of long standing spinal technology which is already in the market for more than few decades.

The provided text describes mechanical performance testing for the AEGIS & AEGIS II Spinal Systems. This is not a study involving AI, human readers, or image analysis, but rather physical stress tests on the device itself. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for each mechanical test. The "data provenance" in this context refers to the manufacturing and testing of the physical device components. The tests were performed on the AEGIS and AEGIS II Spinal Systems themselves. The country of origin for the submitter is Korea. The tests are prospective in the sense that they are conducted on newly manufactured devices to ensure they meet standards.

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

Not applicable. This was mechanical testing of a medical device, not a human reader study or clinical evaluation requiring expert interpretation of data. The ground truth refers to the physical properties and performance of the device under stress, as measured by standard engineering tests.

4. Adjudication method for the test set

Not applicable. This was mechanical testing against established ASTM standards, not a diagnostic or interpretive study requiring adjudication of human readings.

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 was a mechanical performance study of a spinal implant system, not a study involving human readers or AI assistance.

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

Not applicable. This was mechanical testing of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used was the performance of the device under specific mechanical stress tests, compared against the performance of "legally marketed predicate devices" as defined by established ASTM (American Society for Testing and Materials) standards (F1717-04, 543-07, F1798-97).

8. The sample size for the training set

Not applicable. This was not a machine learning study with a training set.

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

Not applicable. There was no training set.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of 4.5mm and 6.35mm rods and are available in various geometries and sizes.

The provided text describes the EXPEDIUM Spine System, a medical device intended for spinal immobilization and stabilization. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in a way that would allow for a complete answer to your request regarding acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study against pre-defined acceptance criteria.

Here's a breakdown of what can be gleaned and what is missing, structured as requested:

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

Explanation: The document states that "Performance data per ASTM F 1717 were submitted." ASTM F 1717 is a standard specification for spinal implant constructs in vitro, likely involving mechanical testing (e.g., fatigue, static strength). However, the specific acceptance criteria (e.g., "must withstand X cycles at Y load," or "static strength must exceed Z N-m") and the device's measured performance against those criteria are not provided in this summary. The summary confirms that data was submitted to characterize the device, implying that a study was conducted, but it does not present the results or the pass/fail thresholds.

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: Not specified for any test set. The ASTM F 1717 standard would typically define the number of constructs to be tested, but this detail is not present in the summary.
• Data Provenance: Not specified. It's an in-vitro mechanical test, so "country of origin of data" is less relevant than for clinical data, but the location of the testing facility is not provided. Retrospective or prospective classification is not applicable to an in-vitro mechanical test.

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

• This question is not applicable to the device and performance data described. The device is a spinal implant system, and the performance data cited (ASTM F 1717) refers to mechanical properties, not diagnostic performance or clinical outcomes requiring expert interpretation to establish ground truth.

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

• Not applicable. As the performance data pertains to mechanical testing (ASTM F 1717), there is no need for expert adjudication. Mechanical tests follow standardized protocols.

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 spinal implant system, not a diagnostic imaging or AI-assisted device. 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 device is a physical spinal implant system, not a software algorithm.

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

• Not applicable in the typical sense of ground truth for diagnostic devices. For mechanical testing (ASTM F 1717), the "ground truth" is established by the physical properties and behavior of the device components under controlled test conditions, measured against the specifications of the standard. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" for this type of performance assessment.

8. The sample size for the training set

• Not applicable. There is no "training set" for a physical medical device undergoing mechanical performance testing. This concept applies to machine learning algorithms.

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

• Not applicable. (See point 8).

Summary of available information:

The 510(k) summary indicates that the EXPEDIUM Spine System is a Class III medical device intended for spinal immobilization and stabilization. It states that "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components." This implies that a study was conducted to evaluate the mechanical properties of the device according to the ASTM F 1717 standard. However, the specific details of this study, including the acceptance criteria, the actual performance results, sample sizes, or any form of "ground truth" that would be applicable to diagnostic or AI devices, are not present in the provided document. The document primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, allowing it to proceed to market without a full PMA.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of 5.5mm rods and are available in various geometries and sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXPEDIUM Spine System, structured to answer your questions:

The provided document is a 510(k) summary for the EXPEDIUM Spine System, specifically for additions to the existing system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy or performance against specific clinical acceptance criteria in the same way a PMA would. Therefore, the study details you're asking for, particularly concerning AI/algorithm performance and human reader improvement, are not applicable to this type of medical device submission. This document describes a surgical implant, not an AI/imaging device.

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

For a spinal implant system like the EXPEDIUM Spine System, "acceptance criteria" are not reported in terms of diagnostic performance metrics (like sensitivity, specificity, etc.). Instead, they relate to mechanical and material performance standards to ensure the device is safe and effective when implanted.

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

The document does not detail a "test set" in the context of clinical data, as it's not a clinical study designed to test diagnostic accuracy. The performance data relates to mechanical testing of the implant components. Therefore, information about sample size, country of origin, and retrospective/prospective nature of a clinical test set is not applicable to this submission.

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

This is not applicable. The ground truth for mechanical testing is established by engineering standards and measurement techniques, not by expert clinician consensus on clinical cases.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish a ground truth from ambiguous cases.

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 is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an AI or imaging device that would involve human readers or AI assistance.

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

This is not applicable. The EXPEDIUM Spine System is a physical surgical implant, not an algorithm or software.

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

For this device, the "ground truth" for its performance is based on engineering standards and material science properties (e.g., strength, fatigue resistance, biocompatibility) as defined by standards like ASTM F 1537 (for material) and ASTM F 1717 (for mechanical testing of spine fusion constructs). There are no clinical outcomes data, pathology, or expert consensus used as ground truth for this type of submission's performance data.

8. The sample size for the training set

This is not applicable. This is a physical implant, not an AI model, so there is no "training set."

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

This is not applicable.

Summary of what the document does provide:

• Device Type: Spinal implant system (rods, screws)
• Purpose of Submission: Special 510(k) for additions to an existing system, demonstrating substantial equivalence to predicate devices.
• Key Performance Data: Mechanical performance data per ASTM F 1717, and material characterization per ASTM F 1537. This data ensures the device meets established engineering standards for strength, durability, and biocompatibility suitable for its intended use.
• Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Material: ASTM F 1537 implant grade cobalt-chromium-molybdenum alloy.

The document demonstrates that the new components for the EXPEDIUM Spine System are substantially equivalent to previously cleared devices based on their design, materials, and mechanical performance testing, not on clinical performance against diagnostic or AI-related metrics.

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The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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); spinaly stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed nrevious fusion.

The Radius® Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.

This 510(k) is intended to introduce an extension to the existing Radius® Spinal System. The proposed line extension includes the addition of a Vitallium rod.

This document is a 510(k) premarket notification for a medical device (Radius Spinal System Line Extension – Vitallium Rod). It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/software devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical implantable device (spinal system with a Vitallium rod). Therefore, the questions related to AI/software performance metrics, training sets, and expert adjudication are not applicable to the content provided.

Here's an analysis based on the provided text, addressing the relevant aspects:

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

• Acceptance Criteria: The document implies that the "acceptance criteria" for this 510(k) revolve around demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through:
  • Material comparability.
  • Design comparability.
  • Indications for Use comparability.
  • Compliance with FDA's "Guidance for Spinal System 510(k)'s May 3, 2004."
• Reported Device Performance:

  Aspect	Performance/Demonstration
  Material	"Documentation is provided which demonstrates the new components of the Stryker Spine Radius® Spinal System to be substantially equivalent to the predicate devices in terms of material..." (Vitallium rod being the new material).
  Design	"...substantially equivalent to the predicate devices in terms of... design..."
  Indications for Use	"The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD)... spondylolisthesis; trauma... spinal stenosis; curvatures... tumor; pseudoarthrosis; and failed previous fusion." (This is identical to predicate devices).
  Engineering Analysis & Testing	"Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spine Radius® Spinal System, including the subject components."

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

• Not applicable. This submission is for a physical medical device, not a software/AI device that would use a "test set" in the context of performance evaluation with patient data. The "testing" mentioned refers to engineering and material testing, not clinical studies with patient data to establish performance metrics like sensitivity/specificity.

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

• Not applicable. See point 2.

4. Adjudication method for the test set

• Not applicable. See point 2.

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

• No, not done. This is not an AI-assisted diagnostic or therapeutic device. It is a spinal implant.

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

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

• Not applicable for AI/software devices requiring ground truth from patient data. For this physical device, the "ground truth" relates to established engineering standards, material properties, and the established safety and efficacy of the predicate devices. The "truth" is that the new Vitallium rod is comparable in function, safety, and effectiveness to existing, legally marketed spinal rods.

8. The sample size for the training set

• Not applicable. See point 2.

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

• Not applicable. See point 2.

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