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The SSCS (Segmental Spinal Correction System) is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracic-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.

When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; previously failed attempts at spinal fusion.

When used as a pedicle screw system in the thoracolumbosacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw system, the SSCS is intended for patients:

• 1. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (level of attachment: L3 and below).
• 4. Who are having the device removed after the development of a solid fusion mass.

The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems. the SSCS is comprised basically of 1) bone screws and hooks for attachment of the device to the spine, 2) longitudinal rods that are attached to the bone screws and hooks either directly or indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

This document describes a 510(k) submission for a medical device, the SSCS (Segmental Spinal Correction System), which is a posterior spinal fixation device. For spinal fixation devices, the "acceptance criteria" and "device performance" are typically defined by mechanical testing standards rather than diagnostic accuracy metrics seen in AI/imaging devices.

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

Acceptance Criteria and Study Details for the SSCS (Segmental Spinal Correction System)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a sample size for the mechanical testing. It mentions "SSCS constructs," implying multiple test specimens were used, but the exact number is not provided.

• Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Mechanical testing of a device itself is not typically classified as retrospective or prospective in the same way clinical trials are.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This question is not applicable in the context of this device. The "ground truth" for a spinal fixation device's mechanical performance is defined by established engineering test standards (ASTM standards), not by human expert consensus or clinical evaluations.

4. Adjudication Method for the Test Set:

This question is not applicable. Mechanical testing results are objective measurements based on standardized protocols, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This submission concerns a physical implantable device, and its performance is evaluated through mechanical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in spirit. The mechanical performance testing of the SSCS constructs is a standalone evaluation of the device itself, without human intervention affecting the measurement of its mechanical properties. The "algorithm" in this context is the physical device's design and material properties.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the SSCS device's performance is established engineering standards and objective mechanical measurements. Specifically, the "ASTM Standard for testing spinal implant devices" serves as the reference for acceptable performance. The comparison also references the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" for the mechanical testing of a physical medical device. This concept applies to machine learning algorithms.

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

This question is not applicable for the same reasons as #8.

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The SSCS (Segmental Spinal Correction System), including the SSCS Offset Hinged Screw, Offset Connector and Drop-on Crosslink Clamps, is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.

When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for:

• scoliosis
• kyphosis
• spinal fractures
• degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• tumors
• stenosis
• spondylolisthesis
• pseudoarthrosis
• previously failed attempts at spinal fusion

When used as a sacral/pedicle screw system, the SSCS is intended for patients:

• 1. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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.
• 4. Who are having the device removed after the development of a solid fusion mass.
     Although the levels of fusion may not go above the L5-S1 joint, the SSCS screws may be inserted into pedicles up to, but not above, L-3.

The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, including the SSCS Offset Hinged Screw, Offset Connector and Drop-on Crosslink Clamps, that are implanted via a posterior surgical approach and assembled to create a spinal construct. The SSCS also includes instrumentation/accessories that aid in assembling and/or implanting the components. Like most other posterior spinal fixation systems, the SSCS is comprised basically of 1) bone screws for attachment of the device to the spine, 2) longitudinal rods that are attached to the bone screws either directly or indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The provided document describes a 510(k) premarket notification for a medical device, the SSCS (Segmental Spinal Correction System) with added components. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance.

Therefore, the document does not provide information on:

• Acceptance criteria for device performance: As a 510(k) submission, the focus is on mechanical equivalence to predicate devices, not on direct clinical performance metrics.
• A study that proves the device meets acceptance criteria: There are no clinical studies or human-in-the-loop studies described in this document to demonstrate clinical performance against acceptance criteria.
• Sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case studies.

However, the document does describe a mechanical performance study. Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a clinical perspective. Instead, the implicit acceptance criterion for the 510(k) is that the mechanical performance of the new components is "at least comparable to, if not better than" predicate devices.
• Reported Device Performance:

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

• Sample Size: Not specified in the document. The testing involved "SSCS constructs incorporating the Offset Hinged Screw, Offset Connector and Drop-on Crosslink Clamps." The number of constructs or individual components tested is not mentioned.
• Data Provenance: The study was a mechanical testing study, not a human or clinical study. The data was generated in a lab setting by the manufacturer (Osteotech, Inc.).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This was a mechanical testing study, not one requiring expert human interpretation of clinical data or images.

4. Adjudication Method for the Test Set

• Not applicable. This was a mechanical testing study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is a type of clinical study involving human readers. This document describes mechanical testing only.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical spinal fixation system, not a software algorithm.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" would be the physical properties and behavior of the device components under defined load conditions, measured by calibrated instruments according to the ASTM standard. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in this context.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

• Not applicable.

Summary of Study:

The "Performance Data" section describes a mechanical testing study performed on the SSCS constructs incorporating the new components (Offset Hinged Screw, Offset Connector, and Drop-on Crosslink Clamps). The testing was conducted "in accordance with the ASTM Provisional Standard for testing spinal implant devices." The results demonstrated that the mechanical characteristics (bending-compression static strength and stiffness, torsional stiffness, and fatigue strength) of these new constructs were at least comparable to, if not better than, those of previously tested SSCS constructs and/or other predicate devices. This mechanical testing served as the basis for demonstrating substantial equivalence for the 510(k) submission regarding the physical characteristics and performance of the device.

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The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows:

1. When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from TI to S2 and is indicated for:

• scoliosis
• kyphosis
• spinal fractures
• degenerative disc disease, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• tumors
• stenosis
• spondylolisthesis
• pseudoarthrosis
• previously failed attempts at spinal fusion

2. When used as a sacral/pedicle screw system, the SSCS is intended for patients:
   a. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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.
   d. Who are having the device removed after the development of a solid fusion mass.
   Although the levels of fusion may not go above the L5-S1 joint, the SSCS screws may be inserted into pedicles up to, but not above, L-3.

The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, including the SSCS Hinged Screw, that are implanted via a posterior surgical approach and assembled to create a spinal construct. The SSCS also includes instrumentation/accessories that aid in assembling and/or implanting the components. Like most other posterior spinal fixation systems, the SSCS is comprised basically of 1) bone screws for attachment of the device to the spine, 2) longitudinal rods which are attached to the bone screws and which transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements which link the two longitudinal rods for added construct stability.

The provided text describes a medical device submission (K971289) for the SSCS (Segmental Spinal Correction System) with the addition of a Hinged Screw component. The acceptance criteria and the study proving it are related to the mechanical performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a numerical "sample size" in terms of how many individual screws or constructs were tested. It refers to "Mechanical testing of SSCS Hinged Screw constructs."

The data provenance is prospective as the testing was conducted specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is not specified, but the applicant (Osteotech, Inc.) is based in Eatontown, NJ, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a mechanical implant, and its "performance" is assessed through biomechanical testing, not by expert interpretation of clinical data or images. Therefore, clinical "ground truth" established by experts in the traditional sense is not relevant for this part of the submission. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves mechanical properties, not clinical assessment by experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret data, typically with AI assistance. The submission concerns a mechanical implant, and its evaluation focuses on its physical properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm or software device. The "performance" is the mechanical integrity of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this mechanical device is established through objective physical measurements derived from standardized mechanical testing. The testing was performed "in accordance with the ASTM Provisional Standard for testing spinal implant devices." This standard defines the methodology and parameters for measuring the mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI model requiring a "training set."

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

Not applicable, as there is no "training set" for a mechanical device.

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