Search Results

The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

The provided text describes the regulatory clearance of the Spinal Edge TITAN Pedicle Screw System. Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, it relies on demonstrating comparable function and performance characteristics to the predicate device as the primary acceptance criterion. The performance is reported in relation to relevant industry standards.

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

• Sample Size: The document mentions "Representative samples of the device" were tested. However, the exact sample size (e.g., number of screws, number of constructs) used for the mechanical testing is not specified.
• Data Provenance: The testing methodology ("ASTM F1717 'Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model'") describes a laboratory-based, ex-vivo (or simulated in-vitro) test. Therefore, it's not applicable to "country of origin of the data" or "retrospective/prospective" in the clinical sense, as it's a mechanical performance study.

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

This information is not applicable to this type of device and study. The "ground truth" here is objective mechanical performance measured against a standard, not expert interpretation of clinical data. The ASTM F1717 standard itself defines the "ground truth" in terms of physical properties and behaviors under specified loads.

4. Adjudication Method for the Test Set:

This information is not applicable. Mechanical testing against a standard does not involve an adjudication method in the way clinical studies or image interpretations do. The results are typically quantitative measurements compared directly to specified limits or benchmarks.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. The TITAN Pedicle Screw System is a physical implant, and its performance is assessed through mechanical testing, not through human reading of cases.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a surgical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established material science properties. Specifically, the ASTM F1717 standard defines the appropriate testing methodology and expected performance characteristics for spinal implant constructs in a vertebrectomy model. The "ground truth" is therefore objective mechanical strength, stiffness, and fatigue resistance as measured against the parameters defined by this engineering standard.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

Ask a specific question about this device

The MONARCH Spine System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Addition of 5.5mm diameter rod, screws, hooks and various connectors to the MONARCH Spine System. The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the MONARCH Spine System, an addition of 5.5mm diameter rod, screws, hooks, and various connectors. It is a medical device submission, and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics against an AI algorithm.

Regarding your numbered requests, based only on the provided text, the following information can be extracted:

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

   Acceptance Criteria (Implied)	Reported Device Performance
   Safety and Effectiveness substantially equivalent to predicate devices	Performance data were submitted to characterize the MONARCH Spine System. (Specific results not detailed in the provided text.)
   Manufactured from ASTM F-136 implant grade titanium alloy	Manufactured from ASTM F-136 implant grade titanium alloy.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document states "Performance data were submitted to characterize the MONARCH Spine System." However, it does not provide details on the sample size used for the test set, the provenance of the data (e.g., country of origin), or whether the data was retrospective or prospective. This information would typically be found in the detailed performance data report, which is not included in this summary.

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):
   As this is a mechanical medical device (spinal implant), the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The "performance data" would likely refer to mechanical testing, biocompatibility testing, and potentially animal or clinical performance data if submitted, but not expert consensus on images. The document does not mention experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable for this type of device and performance data. The document does not mention any adjudication method.

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 device is a spinal implant, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a spinal implant, not an algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For a spinal implant, "ground truth" would generally refer to established engineering standards for mechanical strength, fatigue, biocompatibility, and potentially clinical outcomes if a clinical study was performed. The document vaguely states "Performance data were submitted to characterize the MONARCH Spine System." It does not specify the type of ground truth used beyond the implicit requirement of meeting established regulatory and engineering standards for similar devices.

8. The sample size for the training set:
   This device is a physical implant, not a machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established:
   As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device

The MONARCH Spine System is a pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System Open and Closed Monoaxial Screws are designed to accept a 6.35mm diameter rod and are available in various lengths and diameters.
The MONARCH Spine System Open and Closed Hooks are designed to accept a 6.35mm rod and are available in a variety of geometries.
The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a medical device submission (K023438) for the MONARCH Spine System, but it does not contain acceptance criteria for device performance or a study demonstrating that these criteria have been met.

Instead, the document primarily focuses on:

• Device Description: What the MONARCH Spine System is, including its components (monoaxial screws, hooks) and the materials it's made from (ASTM F-136 implant grade titanium alloy).
• Intended Use/Indications for Use: The specific medical conditions and patient populations for which the device is intended (e.g., immobilization and stabilization of spinal segments for various instabilities and deformities, treatment of severe spondylolisthesis, degenerative disc disease).
• Predicate Devices: Reference to previously cleared MONARCH Spine System devices (K021335, K010576).
• Regulatory Classification: The classification names, regulation numbers, and regulatory class (Class III) for the device.
• FDA Clearance: An FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Statement on Performance Data: A brief, general statement under "PERFORMANCE DATA:" that "Performance data were submitted to characterize the MONARCH Spine System." However, the actual performance data, acceptance criteria, or a description of the study itself are not included in this summary.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document only states that performance data "were submitted" but does not detail what those data were or against what criteria they were judged.

Ask a specific question about this device