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The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of alternative varieties of pedicle screws and surgical instruments to provide surgeons with further options for implant placement and deformity correction. The Stainless Steel Spinal System components can be rigidly locked together creating a construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F 138 and ISO 5832-1.

The provided text describes a medical device, the Stainless Steel Spinal System, and its substantial equivalence to a predicate device based on performance tests. However, it does not include information about AI or machine learning. Therefore, I cannot answer most of your detailed questions regarding acceptance criteria, study design, expert involvement, or ground truth establishment in the context of an AI device.

Here's what I can extract from the provided text regarding the device's performance based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text for AI-related questions):

• Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI system using a test set of data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation of the Provided Information:

The Stainless Steel Spinal System is a physical medical device. The "acceptance criteria" for this device are based on mechanical performance standards (ASTM F-1717 and ASTM F-1798) for spinal implant constructs. The study performed involved conducting these mechanical tests on the device. The reported performance is that the "construct performed as designed and met or exceeded all product specifications," which indicates successful fulfillment of the acceptance criteria based on these mechanical standards.

The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, primarily through material composition, design concept, indications for use, manufacturing, and performance testing for physical, non-AI devices. There is no mention of AI, machine learning, or software components that would require the kind of data-driven performance analysis you've asked about (e.g., test sets, ground truth, expert review).

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The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Stainless Steel Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, and cross-connectors. The Stainless Steel Spinal System components can be rigidly locked together creating a rigid construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F-138 and ISO 5832-1.

Here's a summary of the acceptance criteria and study information for the Stainless Steel Spinal System (K100970) based on the provided text, formatted to address your specific points:

Since the provided text describes a spinal implant system and its mechanical testing, not a diagnostic AI device, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable. I will specify "N/A" for these fields.

Acceptance Criteria and Device Performance for Stainless Steel Spinal System (K100970)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The construct performed as designed and met or exceeded all product specifications." This implies that the specific numerical criteria were met, but the exact numerical thresholds for "product specifications" and the measured performance values are not detailed in this summary.

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

• Sample Size for Test Set: Not specified. (The study involves mechanical testing of device constructs, not data from human subjects or images.)
• Data Provenance: N/A (Mechanical tests are conducted on manufactured devices, not patient data.)

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

• Number of Experts: N/A (Ground truth for mechanical performance is established by engineering standards and test results, not expert consensus.)
• Qualifications of Experts: N/A

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

• Adjudication Method: N/A (Not relevant for mechanical testing.)

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

• MRMC Study: No, this is not an AI/diagnostic device.

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

• Standalone Performance: No, this is not an AI/diagnostic device.

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

• Type of Ground Truth: Engineering standards and design specifications as defined by ASTM F-1717.

8. The sample size for the training set

• Sample Size for Training Set: N/A (This is not an AI/machine learning device that requires a training set.)

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

• Ground Truth for Training Set: N/A

Study Summary:

The study conducted for the Stainless Steel Spinal System involved mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. The tests performed were:

• Static axial compression
• Static torsion
• Dynamic axial compression

These tests were performed in accordance with ASTM F-1717. The results indicated that the device performed as designed and met or exceeded all specified product requirements, supporting its substantial equivalence to the predicate devices.

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The Xia Stainless Steel 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The provided document, K063428, is a Special 510(k) Premarket Notification for a device modification to the Xia® Stainless Steel Spinal System. It focuses on changing the material grade of previously cleared Xia long arm monoaxial and polyaxial screws. As such, the document primarily addresses substantial equivalence based on material, design, and intended use, rather than presenting a clinical study with acceptance criteria for device performance in the way a diagnostic AI device would.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document describes a modification to an existing device, and the demonstration of substantial equivalence relies on engineering analysis and testing to ensure the new material grade performs comparably to the predicate device, not on a clinical effectiveness study measuring human improvement with AI or ground truth established by experts.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies acceptance criteria through discussions of:
  • Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
  • No new types of safety or effectiveness problems raised by the material change.
  • Demonstration of substantial equivalence to predicate devices in terms of material, design, and indications for use.
  • Comparison of design features, materials, intended use, and performance characteristics.
    The specific quantitative pass/fail values for material properties (e.g., tensile strength, fatigue life) are not provided in this summary but would be part of the underlying engineering analysis.
• Reported Device Performance: The document states that "Engineering analysis and testing... was completed for the Stryker Spine Xia® Stainless Steel modified long arm screws." However, the results (i.e., specific performance metrics against quantitative criteria) are not reported in this summary. It only states that the testing was completed to demonstrate compliance.

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. This document describes a modification to an existing mechanical device (spinal screws), not a diagnostic device involving a "test set" of patient data in the typical sense. The "testing" mentioned refers to engineering and laboratory analysis of the device's material and mechanical properties, not a clinical study on human subjects or a dataset for an AI algorithm.

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. As mentioned above, there is no "test set" requiring expert ground truth in the context of this device modification. Expert input might be involved in defining material specifications or testing protocols, but not in a manner consistent with an AI/diagnostic device evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 document is for a spinal implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. This document is for a mechanical spinal implant.

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

• Not Applicable (in the context of AI/diagnostic devices). The "ground truth" for this device modification would relate to established material science properties, mechanical testing standards, and predicate device performance characteristics. For example, material composition would be verified against industrial standards, and mechanical strength would be measured against specific thresholds derived from biomechanical requirements.

8. The sample size for the training set

• Not Applicable. As this is not an AI/diagnostic device, there is no "training set."

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

• Not Applicable.

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The Xia 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUSTM Spinal System arc intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

This 510(k) is intended to introduce an extension to the existing Xia Titanium Spinal System and Xia Stainless Steel Spinal System that includes long arm bone screws and hooks.

The provided document is a 510(k) Premarket Notification for a line extension to the Xia Titanium Spinal System and Stainless Steel Spinal System. It does not describe a study involving acceptance criteria for device performance in the context of an AI/human-in-the-loop system. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

The document primarily states:

• Acceptance Criteria/Proof of Device Meeting Criteria: "Engineering analysis to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal Xia® Titanium Spinal System and Xia® Stainless Steel Spinal System Long Arm Bone Screws and Long Arm Hooks." This indicates that compliance with an FDA guidance document, likely involving mechanical and material testing, served as the "proof," rather than clinical performance metrics in the context of the questions asked.

The entire request is framed around the evaluation of an AI-driven device, which is not what this document addresses. This is a traditional medical device (spinal fixation system) 510(k) submission.

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