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The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (L5-S1) vertebral 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 (levels of pedicle screw fixation may be from L3 to sacrum); and/or (d) who are having the device removed after the development of a solid fusion mass.

TENOR™ Plates are intended for the L5-S1 pedicle screw indication described above only.

The TENORTM Spinal System, when used as a non-pedicle screw fixation system, is intended for the following indications: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) pseudarthrosis, 3) stenosis, 4) spondy|olisthesis, 5) spinal deformities: scoliosis, kyphosis, 6) fracture, 7) unsuccessful previous attempts at spinal fusion, and/or 8) tumor resection. When used for posterior non-pedicle screw fixation, the TENORTM System is intended for thoracic, lumbar, and sacral (T1-Sacrum) fixation only.

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross connectors, nuts, and screws made of medical grade titanium alloy or stainless steel. The TENOR™ Spinal System is used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON( Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

The purpose of this submission is to include additional screws to the system.

This document is a 510(k) summary for the TENOR™ Spinal System, which is a medical device. The information provided in this document is related to device clearance and indications for use, not a study proving the device meets acceptance criteria. Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this text because it is not present. This document describes the device, its intended use, and its substantial equivalence to previously marketed devices, which is a regulatory pathway for approval, not a performance study.

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The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (LS-S1) vertebral 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 (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

TENOR™ Plates are intended for the LS-S1 pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior non-pedicle screw fixation system, is intended for the following indications: 1.) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2.)Pseudarthrosis, 3.) Stenosis, 4.) Spondylolisthesis, 5.) Spinal deformities: scoliosis, lordosis, 6.) Fracture, 7.) Unsuccessful previous attempts at spinal fusion, 8.) Tumor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, connectors, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORM Spinal System may be used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and/or MULTI AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

The provided text is a 510(k) premarket notification for the TENOR™ Spinal System. It details the product description, indications for use, and a statement of substantial equivalence to itself. The FDA letter confirms the device is substantially equivalent to legally marketed devices.

This document does not report on any studies that prove the device meets specific acceptance criteria.

The concept of "acceptance criteria" and performance metrics (like accuracy, sensitivity, specificity) typically applies to medical devices that perform a diagnostic, analytical, or algorithmic function, such as AI-driven software, imaging systems, or lab tests. For these types of devices, performance is quantifiable and a "study" is conducted to demonstrate that the device meets predetermined thresholds.

The TENOR™ Spinal System is a physical spinal implant (components like clamps, screws, plates, rods). For such devices, "acceptance criteria" are usually based on:

• Biocompatibility: Demonstrated through testing to ensure the materials are safe for implantation in the human body.
• Mechanical Strength and Durability: Tested according to recognized standards (e.g., ASTM, ISO) to ensure the components can withstand the stresses and movements of the spine over time.
• Sterilization: Validated methods to ensure the device is sterile when implanted.
• Design and Manufacturing Controls: Adherence to Quality System Regulation (21 CFR Part 820) to ensure consistent quality.
• Substantial Equivalence: As explicitly stated in the document ("Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself."), the primary "study" or justification for market clearance of this type of device is often through demonstrating that it is substantially equivalent to a device already legally on the market. This means it has the same intended use and technological characteristics, or if there are different technological characteristics, they do not raise new questions of safety and effectiveness.

Since the provided text does not contain information about a study with performance metrics or acceptance criteria for algorithm output or diagnostic accuracy, I cannot fill out the requested table or answer most of the questions.

Here's what can be inferred or stated based on the given document, acknowledging its limitations for the specific request:

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

2. Sample size used for the test set and the data provenance
Not applicable. No "test set" of patient data in the context of device performance metrics is described. The "study" mentioned for substantial equivalence is a comparison to a predicate device, not a clinical trial with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "test set" with ground truth established by experts is described for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
Not applicable. This is not an AI or imaging device where human readers would be involved in interpreting outputs.

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

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to the physical and biocompatible properties of the materials, and the established safety and effectiveness of the predicate device it is equivalent to.

8. The sample size for the training set
Not applicable. No "training set" in the context of AI or algorithmic development is mentioned.

9. How the ground truth for the training set was established
Not applicable.

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The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (LS-S1) vertebral 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 (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

TENOR™ Plates are intended for the LS-S I pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc discase (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (TI - Sacrum) fixation only.

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORTM Spinal System may be used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and/or MULTI AXIAL Low Profile MULTI-SPANTM CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

The provided text is a 510(k) summary for the TENOR™ Spinal System. It details the device's description, indications for use, and a claim of substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The statement "Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself" is a very unusual and likely erroneous statement within the context of a 510(k). Typically, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. This implies that the device is either (a) a re-submission of a previously cleared device with minor changes, or (b) the sentence is a typo and refers to a known predicate device that is not explicitly named here. Without further documentation, it's impossible to determine the true basis for substantial equivalence.

Therefore, I cannot fulfill your request for the detailed breakdowns of acceptance criteria, study methodologies, and performance metrics as this information is not present in the provided text.

Here's a breakdown of what is and is not available in the provided document, in relation to your request:

1. Table of acceptance criteria and the reported device performance:

• Not provided. The document states that the system is "substantially equivalent" but does not offer specific performance metrics or acceptance criteria for those metrics.

2. Sample size used for the test set and the data provenance:

• Not provided. No information about a test set, its sample size, or data provenance is present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. There is no mention of a test set, ground truth, or experts establishing it.

4. Adjudication method for the test set:

• Not provided. No information about a test set or adjudication method is present.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not provided. This device is a mechanical spinal system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human-AI collaboration is irrelevant. No information about any comparative effectiveness study is provided.

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

• Not applicable/Not provided. As stated above, this is a mechanical device, not an algorithm. No standalone performance data is provided for the device in general.

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

• Not provided. No information about ground truth is present.

8. The sample size for the training set:

• Not applicable/Not provided. As a mechanical device, there wouldn't typically be a "training set" in the sense of machine learning. There is no information about any study sample sizes.

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

• Not applicable/Not provided. There is no mention of a training set or its ground truth.

In summary, the provided 510(k) pertains to regulatory clearance based on substantial equivalence, and it does not include the detailed study results or performance data that would typically be found in a clinical study report or a more comprehensive technical document.

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