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The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.

This document is related to a 510(k) premarket notification for a medical device called the "Fortis and Hana Anterior Cervical Plate System." This is a spinal implant, and the FDA letter indicates that the device has been found substantially equivalent to previously marketed devices.

Based on the provided text, the document describes performance testing for mechanical properties, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria as typically understood for AI/ML radiology devices is not present.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed." However, it does not provide specific acceptance criteria values or the reported performance values from these mechanical tests. It only states that the testing was done and that the device was found substantially equivalent, implying that it met the necessary performance standards to be considered equivalent to the predicate devices.

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

Not applicable. This was mechanical testing, not a study on a test set of data (e.g., medical images). The testing was performed on the physical device components.

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

Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. This document describes mechanical testing of a physical implant.

4. Adjudication Method:

Not applicable for a mechanical test.

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

Not applicable. This is not an AI/ML device for diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an AI/ML algorithm.

7. Type of Ground Truth Used:

For this type of device, the "ground truth" for mechanical testing would be the engineering specifications and performance values derived from validated test methods (e.g., ASTM F1717). The document implies that the device met these engineering standards by stating "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed" and that the device was found "substantially equivalent."

8. Sample Size for the Training Set:

Not applicable. This is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable.

Summary of Device and Study Information:

• Device: FORTIS and HANA Anterior Cervical Plate System (spinal intervertebral body fixation orthosis)
• Purpose: Anterior fixation to the cervical spine C2-C7 for various indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, failed previous fusion).
• Study Type: Mechanical testing.
• Tests Performed: Static compression bending, Dynamic compression bending, and Static torsion test.
• Standard Followed: ASTM F1717.
• Result: The device demonstrated substantial equivalence to predicate systems based on technical characteristics, performance, and intended use, implying it met the necessary mechanical performance criteria.

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The Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with:

• . Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Spondylolisthesis,
• Trauma (i.e. fracture or dislocation), ●
• Spinal Stenosis,
• . Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
• . Tumors.
• Pseudoarthrosis as a result of failed spine surgery,
• Failed previous fusions, .
• Symptomatic cervical spondylosis
• . Instability following surgery for the above indications.
  Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
  Warning: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS 3G Cervical Plating System is manufactured from Titanium/ Titanium Alloy and will be provided non-sterile.

The provided text describes the Quintex Cervical Plating System, its indications for use, and its substantial equivalence to predicate devices based on biomechanical testing. However, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and a study proving a device meets those criteria, particularly in the context of AI/software performance or detailed clinical trials.

The document discusses performance data in a general sense, stating: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications. All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where relevant. Testing results demonstrate the AIS Quintex Cervical Plating System is safe and effective comparable to other predicate systems currently on the market."

This indicates that mechanical and possibly other non-clinical performance benchmarks were met, but it lacks the detail to fulfill the prompt's request for specific acceptance criteria and study designs relevant to clinical performance, expert adjudication, or AI performance.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not specified in the document. The testing mentioned appears to be mechanical/biomechanical, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as the "ground truth" seems to relate to engineering and biomechanical properties rather than clinical diagnoses.

4. Adjudication method for the test set: Not applicable and not specified.

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 mechanical implant, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: For biomechanical testing, the "ground truth" would likely be established mechanical properties, failure limits, and performance under various loads, as defined by engineering standards and predicate device performance. Specifics are not provided.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

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

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The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions 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), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.

Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable (No test set for clinical performance is described).
• Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.

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

• Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).

4. Adjudication method for the test set

• Not applicable (No adjudication method is mentioned).

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 comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

• Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.

8. The sample size for the training set

• Not applicable (No training set is mentioned as this device is not an AI/ML product).

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

• Not applicable (No training set or associated ground truth establishment is mentioned).

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The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and reoperation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The ABC Cervical Plating System consists of two spinal implant components: bone plates and bone screws. Both implants are manufactured from titanium alloy, Ti6Al4V according to ISO 5832/3 and are provided non-sterile. The 200 generation screw will be self-locking with an internal locking pin and spring. The outer body of the 2nd generation screw is still manufactured from Ti6Al4V while the internal locking mechanism is made from Phynox (cobalt alloy) per ISO 5832/7. The specialized ABC instruments are made primarily of surgical grade stainless steel according to ISO 7153/1 and are hand-held, re-usable devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ABC Cervical Plating System (ABC 2nd Generation Screw):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set. This report describes a pre-market notification (510(k)) where equivalence to a predicate device is established, primarily through mechanical testing, not human-subject clinical trials with test sets in the typical sense of AI/diagnostic device validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a spinal implant, and the "ground truth" for its performance is assessed via mechanical testing and comparison to an existing predicate device, not through expert consensus on diagnostic images or clinical outcomes in the same way an AI diagnostic tool would be.

4. Adjudication Method for the Test Set

Not applicable. As described above, there is no "test set" in the context of clinical images or diagnostic outcomes requiring expert adjudication. The primary "adjudication" is the FDA's review of the mechanical testing data and the sponsor's argument for substantial equivalence.

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

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices involving human readers (e.g., radiologists, pathologists) to assess the impact of an AI tool on their performance. The ABC Cervical Plating System is a surgical implant.

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

Not applicable. The ABC Cervical Plating System is a physical medical device (spinal implant), not an algorithm or AI system. Its performance is assessed through mechanical testing.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the performance of the predicate device (K000486). The new device's performance, as measured by ASTM F2193-02 mechanical testing, is compared against the predicate's known performance to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this device.

Summary of Findings:

The provided document, a 510(k) summary for the ABC Cervical Plating System, describes a medical device (spinal implant) and its regulatory clearance process. The "acceptance criteria" revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is primarily achieved through mechanical testing (specifically referencing ASTM F2193-02), rather than clinical studies involving human subjects or AI algorithm validation. Therefore, many of the requested categories related to AI/diagnostic efficacy studies are not applicable to this type of device and its submission.

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The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), posttraumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.

The ABC Cervical Extension Plate is used to extend the existing anterior stabilization plate (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486).

The ABC E-Plates are exclusively used to extend an existing anterior stabilization plate on the cervical spine, which has been carried out using the ABC system. The E-Plate allows a mono-segmental or bi-segmental extension at the cranial or caudal end of the existing ABC plate.

The provided document is a 510(k) premarket notification for a medical device called the "ABC Caudal and Cranial Extension Plate." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/ML device evaluations. Therefore, a direct response to your request for acceptance criteria and study details (like sample sizes, expert qualifications, etc.) for a performance study proving the device meets those criteria is not present in the document.

The document states:

• "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This explicitly indicates that there are no pre-defined performance standards or acceptance criteria that this device is being tested against in a formal performance study in the way an AI/ML device would be.
• The entire submission hinges on demonstrating "SUBSTANTIAL EQUIVALENCE" to existing, legally marketed predicate devices.

Therefore, many of the requested fields cannot be filled as they pertain to a type of performance study that was not conducted or presented in this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical data of this nature is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert consensus is mentioned as part of a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set.

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/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is discussed in the context of a performance study.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary based on the document:

This 510(k) submission successfully demonstrated that the ABC Caudal and Cranial Extension Plate is substantially equivalent to legally marketed predicate devices. The basis for this determination is:

• Indications for Use: The device shares the same intended use as the predicate devices, which is for stabilizing the cervical spine due to conditions like degenerative disc disease, trauma, tumors, and failed fusions (C2-T1).
• Technological Characteristics: The ABC Cervical Extension Plate is designed to extend existing anterior stabilization plates from the ABC system, indicating a similar mechanism of action and materials to the existing ABC plates and screws (K974706 and K000486), which were the primary predicate devices.
• Performance Data: The document explicitly states "No performance standards have been promulgated... The new ABC System conforms with those and the Guidance for Spinal System 510(k)." This means a formal performance study with predefined acceptance criteria was not required or conducted as part of this 510(k) in the way a novel device or AI/ML product would need. Instead, the equivalence pathway relies on the safety and effectiveness profile of the predicate devices.

The FDA's decision letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Predicate Devices for Substantial Equivalence:

• Aesculap's existing Anterior Cervical Spine Plates and Screws (K974706)
• Aesculap's Anterior Cervical Screw Spinal Fixation System (K000486)
• Osteonics Anterior Cervical Compression Plating System, Line Extension - Howmedica Osteonics Corp. (K992344)
• Howmedica Osteonics Compression Plating System, Cortical Screws – Howmedica Osteonics Corp. (K993181)

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