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The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:

• 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 of 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 Cervical Plating System is manufactured from Titanium Alloy/Phynox and will be provided non-sterile.

Here's a summary of the acceptance criteria and study findings based on the provided document:

This 510(k) submission (K121801) is for minor changes to the Quintex Cervical Plating System and seeks to demonstrate substantial equivalence to a previously cleared device (K100243). Therefore, the "acceptance criteria" are generally that the modified device performs similarly to or better than the predicate device in specified biomechanical tests.

Acceptance Criteria and Reported Device Performance

• Off-axis screw insertion
• Redirection of screw trajectory
• Intentional pry-out | The results of these tests showed that the subject device meets or exceeds the performance of the predicate device, and is therefore found to be substantially equivalent. |

Regarding the study proving the device meets acceptance criteria:

The study referenced is a non-clinical biomechanical testing program.

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

   • The document does not specify the exact sample size (e.g., number of screws, plates, or constructs tested) for each biomechanical test.
   • The data provenance is not explicitly stated beyond being "non-clinical testing" conducted as recommended by FDA Guidance for Spinal System 510(k)s. It's safe to assume this testing was conducted in a laboratory setting, likely in the US or a country with similar regulatory standards, but the specific location is not provided. The data is prospective in the sense that the tests were specifically designed and executed for this submission.

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

   • This question is not applicable in this context. Biomechanical testing of a medical device (like a spinal plating system) does not typically involve human experts establishing a "ground truth" for the test set in the way that image interpretation or diagnostic performance studies do. The "ground truth" here is the physical performance under controlled mechanical conditions, measured against engineering standards and comparison to a predicate device.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where human interpretation or clinical outcomes need to be resolved. For biomechanical testing, the "adjudication" is based on objective, quantifiable measurements and engineering analysis.

4. 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. This type of study is relevant for AI or diagnostic imaging devices, not for a spinal implant system undergoing biomechanical testing for substantial equivalence.

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

   • This question is not applicable. This device is a passive mechanical implant, not an algorithm or a device with AI components.

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

   • The "ground truth" for this study is the objective, quantitative performance data obtained from standardized biomechanical tests (e.g., force, displacement, failure load, rigidity, etc.), as measured and analyzed by engineers and compared against the performance characteristics of the predicate device and relevant engineering standards.

7. The sample size for the training set:

   • This question is not applicable. There is no "training set" in the context of biomechanical testing for a mechanical implant. Training sets are used in machine learning for AI algorithms.

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

   • This question is not applicable as there is no training set for this type of device and study.

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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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