Search Results

The Calvary Spine Pedicle Screw System is 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 thoracic, lumbar, and sacral spine (T1 to S1/ilium); degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Calvary Spine Pedicle Screw System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight and curved rods.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calvary Spine Pedicle Screw System:

Based on the provided FDA 510(k) summary (K201568), there is no information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI/algorithm-based medical device.

The document describes a traditional medical device, specifically a pedicle screw system, which is a hardware implant used in spinal fusion surgery. The "acceptance criteria" discussed in this document refer to the regulatory requirements for establishing substantial equivalence to previously cleared predicate devices, primarily based on design, materials, and mechanical performance through non-clinical testing.

Therefore, I cannot populate most of the requested fields because they are specifically tailored for studies validating AI/algorithm performance.

However, I can extract the relevant information regarding the type of study and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device and not an AI/algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC to list as acceptance criteria for automated diagnosis or analysis. The "acceptance criteria" for this device are broadly the demonstration of substantial equivalence to predicate devices based on:

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

• Not applicable (N/A) for an AI/algorithm test set.
• The "test set" in this context refers to the samples used in non-clinical mechanical testing, which are typically manufactured units of the device. No information on the specific number of units tested for each mechanical test is provided, but it would involve standard engineering sample sizes for material and mechanical property evaluations.
• Data Provenance: The data provenance for mechanical testing would be from internal laboratory testing of the manufactured devices. No country of origin for data in the AI sense is relevant here, nor is retrospective or prospective human data.

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

• N/A for an AI/algorithm test set.
• Ground truth for mechanical properties is established through standard engineering and materials testing protocols (e.g., ASTM standards), not by human experts adjudicating images or clinical data.

4. Adjudication Method for the Test Set

• N/A for an AI/algorithm test set.
• Mechanical test results are objective measurements against defined standards, not subject to human adjudication methods like 2+1 or 3+1.

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. An MRMC study was not done.
• This device is not an AI/algorithm, therefore, there is no human-in-the-loop performance improvement with AI assistance to measure.

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

• No. A standalone algorithm performance study was not done.
• This device is not an AI/algorithm.

7. The Type of Ground Truth Used

• Mechanical and Material Standards: The "ground truth" for this medical device's performance is compliance with established material specifications (e.g., ASTM F136, F67, F1582) and mechanical testing standards for spinal implants, demonstrating equivalent or superior strength to predicate devices.

8. The Sample Size for the Training Set

• N/A for an AI/algorithm training set.
• This device does not involve a training set as it's not an AI/algorithm.

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

• N/A for an AI/algorithm training set.
• Not applicable as there is no training set.

Summary of what was done (based on the provided text):

The Calvary Spine Pedicle Screw System underwent non-clinical testing to demonstrate that it is substantially equivalent to legally marketed predicate devices. This equivalence was established based on:

• Similar materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo).
• Similar intended use.
• Similar design (shape, sizes, manufacturing process).
• Comparable or superior strength values, presumably measured through mechanical testing (though specific tests and methodology are not detailed in this summary).

The document explicitly states: "No clinical studies were performed." This is common for 510(k) clearances where substantial equivalence can be demonstrated through non-clinical data.

Ask a specific question about this device