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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.

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The Integra Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autograft bone. Integra Cervical implant is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Petra PLF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Petra PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Integra Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. To prevent migration, the Integra Cervical Cage has teeth on its superior and inferior surfaces. A large window allows bony growth to form. It has two tantalum x-ray markers.

The Petra PLF Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique. The Petra PLIF implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a PLIF approach. The design is a wedged configuration for ease of insertion.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

The provided document is a 510(k) summary for the Calvary Spine Intervertebral Body Fusion Cages (Integra Cervical Cage and Petra PLIF Lumbar Cage). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria on device performance in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

Here's why and what the document does provide:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria for device performance (e.g., success rates, complication rates, fusion rates). Instead, it states that "Tests performed according to ASTM F2077/F2267 indicate that the Interbody Calvary Spine Intervertebral Body Fusion Cages meet required mechanical strengths."
• Study Details (Sample Sizes, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance): The document describes non-clinical tests for mechanical strength, not clinical trials assessing patient outcomes or diagnostic performance. Therefore, there's no information about:
  • Sample sizes for test or training sets.
  • Data provenance (country, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC comparative effectiveness studies (as there's no "AI" or human-in-the-loop performance being assessed).
  • Standalone performance.
  • Type of ground truth (as it's not a diagnostic or outcome-based study).
  • Sample size for the training set.
  • How ground truth for the training set was established.

Summary from the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: The device must meet the "required mechanical strengths" as determined by ASTM F2077/F2267.
   • Reported Device Performance: "Tests performed according to ASTM F2077/F2267 indicate that the Interbody Calvary Spine Intervertebral Body Fusion Cages meet required mechanical strengths." Specific numerical values or detailed results are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided. The document refers to non-clinical mechanical strength tests, not clinical data sets.

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/Not provided. The "ground truth" here is compliance with mechanical strength standards, not a clinical diagnosis or outcome requiring expert consensus.

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

   • Not applicable/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:

   • No MRMC study was done. This is a medical device for spinal fusion, not a diagnostic AI tool.

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

   • No standalone performance study was done in the context of an algorithm or AI. The tests were purely mechanical.

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

   • The "ground truth" for the mechanical tests would be the specifications and requirements defined by ASTM F2077/F2267.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not a machine learning model.

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

   • Not applicable/Not provided.

This 510(k) summary primarily demonstrates substantial equivalence to existing devices based on similar indications, materials, and designs, supported by non-clinical mechanical testing to ensure the new devices meet established safety and performance standards for intervertebral body fusion cages.

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