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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, hooks, cross connectors and locking caps.

The provided text describes a 510(k) premarket notification for the CONQUEST® Spinal System. This is a medical device submission seeking clearance to market a new device based on its substantial equivalence to an already legally marketed predicate device.

The "Performance Data" section of the document states: "Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence."

This indicates that the device's performance was evaluated through biomechanical testing to meet the standards set by ASTM F1717. However, the document does not provide specific acceptance criteria or the reported device performance results from this testing. It only states that the testing was conducted to demonstrate substantial equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be inferred or explicitly stated based on the provided document:

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

• Acceptance Criteria: The document implies that the acceptance criteria are defined by ASTM F1717 standards for spinal implant testing. However, the specific quantitative acceptance criteria (e.g., specific load limits, displacement thresholds) from ASTM F1717 are not detailed in this submission.
• Reported Device Performance: The document states that biomechanical testing was conducted "to demonstrate substantial equivalence." It does not provide the specific performance data (e.g., actual measured strength, stiffness, or fatigue life values) obtained from these tests for the CONQUEST® Spinal System.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. It is biomechanical testing, not clinical data, so country of origin for patients/data is not applicable. The testing would have been conducted in a lab.

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)

• This question is not applicable. The "ground truth" for biomechanical testing is typically the measurement of physical properties against established engineering standards (like ASTM F1717), not expert interpretation of clinical data or images.

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

• This question is not applicable to biomechanical testing.

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

• This question is not applicable. The submission is for a spinal fixation system, not an AI-powered diagnostic device. No clinical reader studies are mentioned.

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

• Not applicable as this is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance evaluation is based on established engineering and biomechanical standards (ASTM F1717), not clinical expert consensus or pathology.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device that requires a training set.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, and locking caps.

This 510(k) summary describes a spinal implant system, not an AI/ML powered medical device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test sets and training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable in this context.

However, I can provide the available information regarding the device's acceptance criteria and the study performed as described in the provided text.

Acceptance Criteria and Device Performance for CONQUEST® Spinal System

Explanation for AI-specific questions (Not Applicable for this Device):

This device, the CONQUEST® Spinal System, is a traditional medical implant, specifically a spinal fixation system. The provided 510(k) summary focuses on demonstrating its mechanical properties and equivalence to existing, legally marketed devices. It does not involve any artificial intelligence or machine learning components for diagnosis, prognosis, or treatment decisions. Therefore, the following information is not provided nor applicable:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this type of device would refer to physical prototypes undergoing mechanical testing, not a dataset for an algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is irrelevant here. The "ground truth" for a spinal implant's performance would be derived from mechanical test standards (ASTM F1717) and engineering principles.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device does not involve human readers interpreting data with or without AI assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the biomechanical performance, the "ground truth" is adherence to established engineering standards (ASTM F1717) and functional equivalence to predicate devices, rather than clinical outcomes or diagnostic ground truth.
7. The sample size for the training set: Not applicable. This device does not involve a training set.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device