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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 All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable.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 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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