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The subject components of the Osteonics® Spinal System Variable Offset Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6A14V ELI Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6AV ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.

The Osteonics® Spinal System, including the subject additional components, is intended for fixation of the T4-S2 spine. All bone screws are indicated for sacral fixation, or for limited pedicular fixation. When used as a pedicle screw system is intended only for use with autogenous bone graft in order to facilitate fusions of the LS-S1 joint in patients with grade 3 or 4 spondylolisthesis. The screws are not intended for placement in the pedicles above L3, and are intended for removal after development of a solid fusion mass.

For non-pedicular use:

• Long and short curve scoliosis, ●
• Vertebral fracture or dislocation, ●
• Spondylolisthesis,
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

For pedicular use:

• When used as a pedicle screw system, the system is intended 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; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

The Osteonics® Spinal System Variable Offset Connector Assembly may be used in any application where greater flexibility in bone screw placement is needed. This assembly allows a spinal rod to be joined to a bone screw when variations in the distance between these two components exists. The Variable Offset Connector is provided with a Ball Ring, which secures into the top of the bone screw. The bone screw is rotated to provide an access to the Variable Offset Connector in conjunction with the longitudinal construct. The Osteonics® Spinal System Clamping Screw is used with the Variable Offset Connector to provide a stable lock on the longitudinal rod.

The connector features a cylindrical arm at one end, a center round hole, and an open-ended split screw hole at the other end. The Ball Ring component is preassembled around the cylindrical arm. The round hole accommodates the spinal rod, and the split screw hole accepts the Clamping Screw, which secures the spinal rod into place.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of device performance, as these are typically defined within the scope of clinical or simulated-use testing for assessing efficacy or safety.

Instead, the document is a 510(k) Premarket Notification Summary of Safety and Effectiveness for a new component (Variable Offset Connector Assembly) within an existing spinal system (Osteonics® Spinal System). The focus here is on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical trial design and performance evaluation against predefined criteria, which is a different regulatory pathway or stage of development.

However, I can extract information related to the device's technical comparison and its intended use, which indirectly relate to why it might be considered safe and effective by comparison.

Based on the provided text, here is what can be inferred or explicitly stated:

Analysis of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" for device performance (e.g., success rates, complication rates, specific functional outcomes in patients) or "reported device performance" against such criteria are present in this 510(k) summary.

The document states:

"Fatigue and static testing demonstrates the mechanical and endurance properties of these components."

This indicates that mechanical testing was performed, but the specific acceptance criteria for this testing (e.g., minimum load-bearing capacity, fatigue cycles) and the quantitative results are not provided in this summary. The purpose of this testing is to demonstrate that the new component is comparable in mechanical integrity to its predicate devices, rather than meeting novel performance criteria.

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

• Test Set Sample Size: Not applicable. This document describes a mechanical testing approach, not human clinical data or performance data from a specific "test set" of patients.
• Data Provenance: The mechanical testing would have been conducted in a laboratory setting. No country of origin for data is specified, as it's not patient data.
• Retrospective or Prospective: Not applicable, as it's mechanical testing, not clinical data.

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

• Number of Experts: Not applicable. Ground truth, in this context, would relate to clinical diagnosis or outcome assessment, which is not part of this 510(k) summary. Mechanical testing relies on engineering standards and measurements, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This summary does not involve clinical data requiring adjudication.

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

• MRMC Study: No, an MRMC study was not done. This type of study is for evaluating diagnostic performance (e.g., imaging devices) where multiple human readers interpret cases, often with and without AI assistance. This 510(k) is for a spinal implant component.
• Effect Size of Human Readers Improvement with/without AI: Not applicable.

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

• Standalone Performance: Not applicable. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical testing mentioned, the "ground truth" would be established by engineering standards and measurements (e.g., force applied, displacement, cycles to failure) according to recognized test methodologies for spinal implants. This is distinct from clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that requires a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Spinal implant component (Variable Offset Connector Assembly).
• Purpose of 510(k): To demonstrate substantial equivalence to legally marketed predicate devices (TSRH™ Spinal System; ISOLA Spinal System).
• Method of Equivalence Demonstration: Shared materials, intended uses, basic design concepts, and "Fatigue and static testing demonstrates the mechanical and endurance properties of these components." This implies that the mechanical properties of the new device are comparable to or better than predicate devices, fulfilling the requirements for substantial equivalence.
• Intended Use: Fixation of T4-S2 spine. Specific indications for non-pedicular and pedicular use (L5-S1 for severe spondylolisthesis grades 3 & 4 with autogenous bone graft, removed after fusion).
• Materials: ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6A14V ELI Alloy.

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