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The components of the Spiral Radius 90-DTM SST System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The Indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, The Spiral Radius 90-D™ SST System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-DTM SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Spiral Radius 90-DJM SST System consists of stainless steel rods attached to the spinal column through the use of hooks. Screws may be used to attach rods to the spinal column in certain select patients and certain select levels (See Indications). Cross-bars may be used to connect rods to provide a more rigid construct, as well as screws to rods, and hooks to rods. Screws and hooks are provided in several sizes to accommodate varying patient morphology.

The provided document is a 510(k) summary for a medical device called the "Surgical Dynamics Spiral Radius 90-DTM SST System," an orthopedic spinal fixation system.

It does not describe any acceptance criteria or studies proving the device meets those criteria in the way typically associated with performance evaluations of AI/ML or diagnostic devices. Instead, this document is a regulatory submission demonstrating substantial equivalence to a previously marketed device. This means the device is deemed safe and effective because it is similar to another legally marketed device, not through direct performance studies against specific criteria.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of regulatory submission and evaluation.

Here's what can be inferred or explicitly stated based on the provided text, and what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided. This document does not contain acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or engineering performance metrics with thresholds). It is a substantial equivalence claim, not a performance study report.

2. Sample Size Used for the Test Set and Data Provenance:

• Cannot be provided. There is no "test set" in the context of this 510(k) submission. The substantial equivalence claim relies on comparing the new device to a predicate device, not on testing the device against a defined dataset of patients/cases.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Cannot be provided. Since there's no test set or performance evaluation against a ground truth, there were no experts used in this capacity.

4. Adjudication Method:

• Cannot be provided. Not applicable due to the reasons above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Cannot be provided. There is no mention of an MRMC study. This type of study is common for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance, which is not the subject of this 510(k) submission.

6. Standalone Performance Study (Algorithm Only):

• Cannot be provided. This document is for a mechanical spinal fixation system, not an algorithm or AI-driven device. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used:

• Cannot be provided. Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device to which the Spiral Radius 90-D™ SST System is compared.

8. Sample Size for the Training Set:

• Cannot be provided. This device is hardware; it does not involve training data or algorithms in the context of this 510(k) submission.

9. How Ground Truth for the Training Set Was Established:

• Cannot be provided. Not applicable.

Summary based on the document:

This 510(k) submission (K021825) outlines the Surgical Dynamics Spiral Radius 90-DTM SST System, a spinal fixation system consisting of rods, screws, hooks, and cross-bars. The device's components, indicated uses (anterolateral/anterior, nonpedicle posterior, and pedicle screw systems for various spinal segments and conditions), and the claim of substantial equivalence to an existing marketed device are described. This regulatory pathway means that the device's safety and effectiveness are established by its similarity to a legally marketed predicate device, rather than through independent studies evaluating specific performance criteria against a ground truth.

Key takeaway for your request: This document is not the type that would contain the specific performance metrics, study designs, and ground truth information you're asking for, as it's a "substantial equivalence" claim for a hardware device, not a performance study report for a diagnostic or AI-enabled device.

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The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spines. The points of attachment and methods are screw fixation to the anterolateral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachments are the lumbar, thoracic and cervical spine and sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacraliliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudoarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system, in the noncervical spine of skeletally mature patients, the Spiral Radius 90-D™ SST System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The components of the Spiral Radius 90-D™ SST System are indicated for spinal fixation. The material used is medical grade stainless steel material that conforms to ASTM F138.

This document describes a spinal fixation device, the Spiral Radius 90-D™ SST System, that received 510(k) clearance. A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on demonstrating that the device meets specific acceptance criteria through a clinical study. Therefore, the provided text does not contain information about acceptance criteria, device performance, or a study to prove it meets them in the way a traditional clinical efficacy study would.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. 510(k) clearance relies on substantial equivalence to a legally marketed predicate device, rather than meeting specific performance criteria demonstrated by new clinical data for the device itself.

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. The document describes a 510(k) clearance for a spinal fixation system, which is based on demonstrating substantial equivalence to predicate devices (K992784, K000009, and K954696). This process typically involves comparison of design, materials, and intended use, along with non-clinical performance testing (e.g., mechanical testing to ASTM standards for materials as mentioned in the document), rather than a clinical trial with a "test set" in the context of device performance data from human subjects.

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 provided. As noted above, a clinical "test set" and associated ground truth established by experts is not described for this 510(k) submission.

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

This information is not provided.

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 provided. The device described is a spinal fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not applicable and not mentioned.

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

This information is not provided. The device is a physical implant, not an algorithm, so a standalone performance evaluation in this context is not applicable.

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

This information is not provided. The 510(k) clearance process for this type of device does not typically involve establishing a "ground truth" for clinical performance in the same way a diagnostic device or AI algorithm would. Instead, it relies on demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device. The materials used conform to ASTM F138, indicating reliance on established material standards.

8. The sample size for the training set

This information is not provided. A "training set" for an AI algorithm is not relevant to this type of device submission.

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

This information is not provided. Not applicable for this device.

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