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The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
• Spondvlolisthesis .
• Trauma (i.e., fractures or dislocations) .
• Tumors .
• Deformity (defined as kyphosis, lordosis, or scollosis) .
• Pseudoarthrosis .
• Failed previous fusions .

The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes a medical device, the IST Anterior Cervical Plate System, and its 510(k) submission (K072650) to the FDA. The submission focuses on substantial equivalence to predicate devices rather than a standalone clinical study proving specific performance metrics against an acceptance criterion.

Therefore, the information traditionally found in a comprehensive acceptance criteria study (like those for AI/Software as a Medical Device - SaMD) is not present in this document. This submission relies on performance data based on mechanical testing.

Based on the provided text, the direct answers to your questions are as follows:

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

Explanation: In this 510(k) submission, the "acceptance criteria" for the device's performance are implicitly tied to demonstrating substantial equivalence through mechanical testing according to a recognized standard (ASTM F1717). There are no specific numerical clinical performance metrics (e.g., sensitivity, specificity, accuracy) defined in this document that the device had to meet. The performance reported is that it met the ASTM F1717 standard, indicating mechanical equivalence.

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

Not applicable. This submission primarily relies on mechanical testing, not a clinical test set with patient data. Therefore, there is no "test set" in the context of patient data, sample size for such a set, or data provenance. The "testing" refers to mechanical properties in a lab setting.

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. As there is no clinical test set with patient data, there was no need for experts to establish ground truth for such a set.

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

Not applicable. Without a clinical test set requiring expert interpretation or labeling, there is no 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

Not applicable. This device is a physical implant (Anterior Cervical Plate System), not an AI/software device designed to assist human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the physical standards and measurement methodologies outlined in ASTM F1717, which determine material properties and performance under stress. It does not involve clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of this particular 510(k) submission: This 510(k) for the IST Anterior Cervical Plate System is a traditional submission for a physical medical implant. It primarily relies on mechanical testing (ASTM F1717) to demonstrate substantial equivalence to existing predicate devices. It does not involve clinical trials with patient data, AI algorithms, or human-in-the-loop performance studies. Therefore, many of the questions related to clinical performance, ground truth, and AI-specific evaluations are not applicable to the information provided in this document.

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The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

The Paramount™ Intervertebral Body Fusion Device is made of PEEK-OPTIMA®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The devices are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided 510(k) summary for the Paramount™ Intervertebral Body Fusion Device describes performance data primarily related to mechanical testing and biocompatibility, not an AI/algorithm-based device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they relate to AI/algorithm performance rather than a traditional medical device's physical and biological properties.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This device is a physical implant, not an AI/algorithm. The "test set" in this context would refer to material samples or device prototypes subjected to mechanical and biological tests, not a dataset of patient information. The document does not specify the number of samples used for these tests.

• Country of origin of the data: Not specified.
• Retrospective or prospective: Not applicable.

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

Not applicable. The "ground truth" for mechanical testing is defined by the standards themselves (e.g., passing a certain load or fatigue cycle). For biocompatibility, it's defined by biological assays. No human experts in the sense of adjudicating medical images or clinical outcomes were involved in establishing "ground truth" for these performance tests.

4. Adjudication Method for the Test Set

Not applicable. This concept pertains to resolving discrepancies in expert labeling of data, which is not relevant for the described performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretative devices to assess the impact of AI on human reader performance. The Paramount™ Intervertebral Body Fusion Device is a therapeutic implant.

• Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.

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. The device is not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is established by the pass/fail criteria defined in industry standards (ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02) which relate to structural integrity, strength, and fatigue resistance.
• Biocompatibility Testing: Ground truth is established by the pass/fail criteria defined in international standard ISO10993, which assesses the biological response to the device material (PEEK-OPTIMA®).

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

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

Not applicable, as there is no training set for this type of device.

Summary regarding AI/Algorithm Context:

The provided 510(k) document is for a physical medical device (an intervertebral body fusion device) and does not describe an AI or algorithm. Therefore, requests relating to AI/algorithm validation methodologies (like training/test sets, ground truth establishment by experts, MRMC studies, standalone performance) are not applicable to the information contained within this specific regulatory submission. The performance data focuses on mechanical and biocompatibility testing to demonstrate substantial equivalence to predicate devices, which is standard for orthopedic implants.

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The Paramount™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

The Paramount™ VBR device is a single piece device that may be implanted singly or in pairs. All devices are made of PEEK-Optima®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The system implants are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes the Paramount™ VBR System, a device for vertebral body replacement, and its 510(k) clearance. However, it does not contain information about a study based on acceptance criteria for device performance with a specific output metric, such as those typically found in AI/ML device submissions. The performance data mentioned refers to mechanical testing according to general ASTM standards and biocompatibility.

Therefore, many of the requested items related to a study proving the device meets acceptance criteria cannot be answered from the provided text.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Device Performance:

Information Not Available in the Provided Text:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

Explanation:

This document is a 510(k) summary for a traditional medical device (spinal implant), not an AI/ML-powered device. The "performance data" refers to standard engineering and biocompatibility tests to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics (like sensitivity, specificity, AUC) for an algorithm's output. Therefore, the details requested for AI/ML device studies (such as test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission and are not present in the provided text.

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When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 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) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

The IST Pedicle Screw System includes pedicle screws. polyaxial screw heads, locking caps and rods. The components are fabricated from titanium alloy (ASTM F-136). The system can be used in either percutaneous or open surgery procedures. The system components are provided clean and nonsterile for steam sterilization at the user's facility.

This document is a 510(k) summary for the Innovative Spinal Technologies Pedicle Screw System. It provides information for marketing the device. However, it does not contain any performance data from a study used to prove the device meets specific acceptance criteria.

Here's why and what's missing:

• "PERFORMANCE DATA: Performance data were submitted." This line indicates that performance data was submitted to the FDA, but the document itself does not present or describe that data, nor does it list specific acceptance criteria.
• 510(k) Pre-market Notification: A 510(k) is a pre-market submission demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. While this process may involve some performance testing, the 510(k) summary provided here focuses on the device description, intended use, and substantial equivalence, rather than detailed study results against acceptance criteria as requested in the prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance (for a study of performance).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory clearance document, not a detailed scientific study report.

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