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The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod. The Cobalt Chrome Rods are for use with the Zenius or Iliad System. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medyssey Cannulated Pedicle Screws and Cobalt Chrome Rods:

1. Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical (bench) testing for the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The acceptance criteria are implicitly defined by the chosen ASTM standard and the comparison to predicate devices, which means the new device must perform at least as well as the legally marketed predicates.

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

• Test Set Sample Size: The document does not specify the exact number of devices (screws/rods) tested for each non-clinical test (static compression, torsion, tension, dynamic compression). Standard test methodologies for medical devices like ASTM F1717-04 typically require a minimum number of samples for statistically valid results, but these specific numbers are not detailed in this summary.
• Data Provenance: The data is from non-clinical (bench) testing performed by Medyssey Co. Ltd. The country of origin of the testing data is not explicitly stated, but Medyssey is a Korean company with a US-based contact for regulatory purposes.

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

This information is not applicable as the study described is non-clinical (bench testing) of physical device properties, not a clinical study involving human patients or expert interpretation of medical data. The "ground truth" here is the measured mechanical performance of the device against established engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical (bench testing). Adjudication methods are typically employed in clinical studies or studies involving expert review of medical images/data to resolve discrepancies in interpretation.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (spinal pedicle screws and rods), not an AI/software device. Therefore, there is no mention of human readers or AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical study is:

• Engineering Standards and Specifications: Adherence to ASTM F1717-04.
• Predicate Device Performance: The mechanical performance of the new device was compared to that of legally marketed predicate devices. The implicit ground truth is that the predicate devices are safe and effective, and therefore, a device demonstrating equivalent or superior mechanical properties would also be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set

This information is not applicable as the study described is non-clinical (bench testing) of a physical device. There is no concept of a "training set" for this type of evaluation.

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

This information is not applicable as there is no training set for this non-clinical study.

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The TiLock 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: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Genesys Spine TiLock Pedicle Screw System is comprised of polyaxial screws (standard and cannulated) and monoaxial screws in various lengths and diameters, lock plugs, cross-links, tulips and rods in various lengths. The Til.ock System allows the placement of either 5.5mm titanium or 5.5mm cobalt chromium rods. The TiLock cannulated polyaxial screws may be implanted via a minimally invasive technique. Manual instrumentation for implantation of the svstem is available for both conventional and minimally invasive procedures. The minimally invasive procedure is performed using k-wire and fluoroscopy, which allows the implanting surgeon to employ two smaller incisions rather than a longer midline incision.

The subject device is the result of modifications to the existing Genesys Spine TiLock rod system which resulted in the inclusion of a 5.5mm straight and prebent cobalt chromium rod to the system. The subject device shares the same intended use and fundamental scientific technology as the predicate device.

The Genesys Spine TiLock Pedicle Screw System is a medical device. Here's a breakdown of the information regarding its acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The provided document describes the device's substantial equivalence to predicate devices, rather than establishing specific quantitative performance acceptance criteria for diagnostic output. The primary "acceptance criteria" here is demonstrated substantial equivalence in terms of mechanical and material properties, meaning the modified device performs similarly to or better than previously approved devices.

2. Sample Size and Data Provenance for Test Set

• Test Set Sample Size: Not explicitly stated as a distinct "test set" in the context of typical AI algorithm evaluation. The evaluation is based on design verification results, finite element analysis, and material property analysis. These generally do not involve a "sample size" of patient data or images in the same way. Instead, they refer to the number of simulations, physical tests, or material samples analyzed. The document does not specify these numbers.
• Data Provenance: Not applicable in the context of this type of device submission. The evaluation is non-clinical, focusing on engineering and material properties, not patient data.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not applicable. Ground truth, in this context, refers to established engineering standards, material science principles, and mechanical testing protocols.
• Qualifications of Experts: Not explicitly stated. However, it's inferred that the "design verification results" and "finite element and material property analysis" were conducted by qualified engineers and material scientists.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The evaluation relies on objective engineering and material testing, not subjective human assessment needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This device is a pedicle screw system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Standards and Specifications: Mechanical strength, fatigue limits, material compatibility, and overall design integrity according to established biomechanical and medical device standards.
  • Predicate Device Performance: The primary ground truth is the performance characteristics of the legally marketed predicate devices, to which the new device is compared for substantial equivalence.

8. Sample Size for Training Set

• Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a "training set" of data.

9. How Ground Truth for Training Set was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Genesys Spine TiLock Pedicle Screw System meets its (implied) acceptance criteria is a non-clinical engineering and material science evaluation. This evaluation aimed to demonstrate substantial equivalence to existing predicate devices.

The key components of this study were:

• Finite Element Analysis (FEA): This is a computational method used to predict how a product reacts to real-world forces, heat, vibration, fluid flow, and other physical effects. It simulates the mechanical behavior of the pedicle screw system under various loads and conditions to ensure its structural integrity.
• Material Property Analysis: This involves characterizing the mechanical, chemical, and physical properties of the materials used in the device (e.g., titanium, cobalt chromium). This ensures the materials meet required standards for strength, biocompatibility, and durability.
• Design Verification Results: This encompasses a range of tests and analyses to confirm that the device design meets its intended specifications and functions as expected. This could include bench testing for mechanical performance, dimensional analysis, and other forms of verification.

Conclusion: The regulatory submission states that these non-clinical performance data (finite element, material property analysis, and design verification results) were sufficient to demonstrate that the Genesys Spine TiLock Pedicle Screw System is substantially equivalent to its predicate devices. This means that, based on these engineering and material science studies, the device is considered as safe and effective as other devices already legally marketed for the same intended use. No clinical studies were deemed necessary for this particular submission.

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The APEX Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The APEX 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 APEX Spine System is also a hook and sacraliliac screw fixation system of the non-cervical 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 (pseudo-arthrosis).

The added Ø5.50mm and Ø6.0mm CoCr Spinal Rods are identical to the existing devices of the previously cleared APEX Spine System with recards to indications for use and function. The Ø5.50mm and Ø6.0mm CoCr Rods are available in various lengths and are designed for use with the previously cleared titanium alloy components of the APEX Spine System which can accept a Ø5.50mm and/or Ø6.0mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The Ø5.50mm and Ø6.0mm CoCr Rods will be labelled as components of the APEX Spine System.

The provided text describes a 510(k) submission for the APEX Spine System with CoCr Rods. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating the performance of an AI model or diagnostic device against acceptance criteria.

Therefore, the input does not contain the information necessary to complete the requested table and details regarding acceptance criteria and studies proving device performance in the context of AI or diagnostic accuracy studies. The document explicitly states:

• "No clinical studies were performed."
• The non-clinical tests were ASTM standards for mechanical properties of spinal implants.

Given this, I cannot fill out the requested table or provide information about:

1. Acceptance criteria and reported device performance (in terms of diagnostic accuracy/AI performance): Not applicable, as this is a mechanical spinal implant, not an AI or diagnostic device. Performance is typically assessed through mechanical testing and substantial equivalence, not diagnostic metrics.
2. Sample size for the test set and data provenance: No clinical/diagnostic test set was used. Mechanical testing involved specific constructs.
3. Number of experts used to establish ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of diagnostic performance.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document is purely about the regulatory clearance of a physical medical device (spinal rods) based on material specifications, intended use, and mechanical testing, demonstrating substantial equivalence to predicates.

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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.

This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .

oneumonde (HF) MIC Susceptionity Frates -

Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for

Viridans group streptococci.

Streptococcus pneumoniae,

Streptococcus pyogenes

The following in vitro data are available but their clinical significance is unknown:

Streptococcus agalactiae

" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae

Streptococcus spp.

Not Found

The provided text describes a 510(k) premarket notification for a medical device called "Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates." This device is used for determining the antimicrobial susceptibility of various Haemophilus and Streptococcus species to specific antibiotics (Cefepime, Chloramphenicol, and Ceftriaxone). However, the document does not contain the acceptance criteria or the study details proving the device meets those criteria.

The text is a communication from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device, thus allowing it to proceed to market. It outlines regulatory information, product codes, and class designation. The "Indications for Use" section lists the specific bacterial species and antibiotics for which the device is intended.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and study details. The document is a regulatory approval letter, not a scientific study report.

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