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The Synthes Posterior Universal Spinal System devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Synthes Posterior Universal Spinal System consists of stainless steel or titanium components and consists of rods, hooks, side-opening screws with collar and nut (including he subject 9mm diameter side opening screw), variable axis screws with rod and screw connector, collar, locking ring and nut, a trans-connector system, open and closed transverse bars, parallel connectors. Schanz screws, clamp with posterior nut and associated manual surgical instruments.

The provided text is a summary of safety and effectiveness information for the Synthes Posterior Universal Spinal System and the FDA's response to its 510(k) premarket notification. It describes the device, its intended use, and the FDA's determination of substantial equivalence.

However, a critical review of the provided text reveals that it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document states: "This system is substantially equivalent to previously cleared Synthes spinal systems and is supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation." This implies that testing was performed, but the details of that testing, including acceptance criteria and results, are not present in the provided excerpts.

Without a detailed study report, it's impossible to completely fill out the requested table and answer all questions. Based solely on the information provided, here's what can be inferred or stated about the lack of information:

Acceptance Criteria and Device Performance

The provided text does not explicitly state acceptance criteria or report specific device performance metrics in a quantifiable manner. It broadly states that the system is "supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation" and is "substantially equivalent to previously cleared Synthes spinal systems."

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Based on available information)

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

   • Not specified. The document mentions "testing," but provides no details on the sample size of any test sets. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.

2. 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 / Not specified. The document does not describe any studies involving human experts establishing ground truth for a test set. The evaluation seems to be based on engineering tests and comparison to predicate devices, rather than clinical efficacy studies in the format often seen for AI/diagnostic devices.

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

   • Not applicable / Not specified. No information is provided about adjudications for a test set.

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. This is a medical device (spinal implant system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described for this type of product.

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

   • Not applicable. This is a physical spinal implant system, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

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

   • Not explicitly stated in the provided text. For a spinal implant, "ground truth" would typically relate to biomechanical performance (e.g., stiffness, fatigue life, pull-out strength based on industry standards) or an assessment of successful fusion in a clinical setting (outcomes data). The document refers to "testing which satisfies the requirements," implying a comparison against established standards or predicate device performance.

7. The sample size for the training set:

   • Not applicable/Not specified. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is. If "training set" refers to data used to inform the design, it's not detailed in the provided text.

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

   • Not applicable/Not specified. As above, the concept of a "training set" is not relevant in the context of this physical medical device.

Conclusion:

The provided document (K983530) is a 510(k) summary for a spinal implant system. Its primary purpose is to demonstrate substantial equivalence to legally marketed predicate devices, rather than to detail a comprehensive study with acceptance criteria, performance metrics, and rigorous statistical analysis in the way one might expect for a novel diagnostic or AI device. The text indicates that testing was done to satisfy requirements for posterior thoracolumbar and sacral fixation, but the specifics of that testing (methodology, acceptance criteria, results, sample sizes, etc.) are not included in this summary.

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When used as a posterior pedicle screw fixation system, the Synthes Posterior Universal Spinal System devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, the Synthes Posterior Universal Spinal System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5 - S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system, Synthes Posterior Universal Spinal System devices are intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine. In addition, when used with the 3.5mm / 6.0mm parallel connector, the Synthes Posterior Universal Spinal System can be linked to the Posterior Cervical/Thoracic Hook/Rod System.

Synthes Posterior Universal Spinal System. This system consists of stainless steel or titanium components and associated manual surgical instruments. The components include rods, hooks, side-opening screws with collar and nut, variable axis screws with connector, collar, locking ring and nut, trans-connector system, open and closed transverse bars, parallel connectors, Schanz screws, and clamp with posterior nut.

This document describes the Synthes Posterior Universal Spinal System, a medical device. The information provided is a Premarket Notification (510(k)) Summary to the FDA, which focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical studies for novel technologies.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample sizes for test/training sets, ground truth establishment details, expert qualifications, adjudication methods, or MRMC studies) are not typically included or required in a 510(k) submission for this type of device.

The "acceptance criteria" here refer to the safety and effectiveness requirements for spinal fixation systems, which are satisfied through a combination of design, material testing, and a comparison to predicate devices that have already met these criteria.

Here's an attempt to address your request based on the provided text, recognizing the limitations of a 510(k) summary for a mechanical device:

Acceptance Criteria and Device Performance for the Synthes Posterior Universal Spinal System (K982987)

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the Synthes Posterior Universal Spinal System, the "acceptance criteria" are generally established through

• Regulatory Standards: Adherence to established FDA regulations and guidance for spinal fixation systems.
• Performance Benchmarks: Demonstrated equivalence in mechanical and material properties to legally marketed predicate devices.
• Intended Use Compatibility: The device must perform its intended function (immobilization and stabilization of spinal segments, acting as an adjunct to fusion) safely and effectively within the specified indications.

The provided 510(k) summary indicates that the device meets these criteria through a claim of "substantial equivalence" to previously cleared Synthes spinal systems.

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

• Sample Size: Not applicable in the context of a 510(k) for a mechanical spinal system. This submission relies on in vitro mechanical testing and comparison to predicate devices, not patient-specific test sets or clinical trial data in the way an AI diagnostic device would. There is no mention of a "test set" in the context of patient data.
• Data Provenance: Not applicable. The "data" here refers to the design specifications, material properties, and mechanical test results of the device and its predicate, rather than retrospective or prospective clinical data from human subjects.

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

• Not applicable. The "ground truth" for a mechanical spinal implant demonstrating substantial equivalence is based on engineering principles, material science, and the functional success of predicate devices. Clinical "ground truth" (e.g., pathology, imaging expert consensus) as you might find for an AI diagnostic device is not the basis of this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication by clinical experts in this 510(k) submission.

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

• No, not done. This is a mechanical device, not an AI-assisted diagnostic or treatment planning system. MRMC studies are designed to assess the performance of diagnostic tools (often AI) in a clinical setting compared to human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This device is a mechanical implant, designed to be implanted by a human surgeon. It does not operate as a standalone algorithm.

7. Type of Ground Truth Used

• For regulatory purposes in this 510(k), the "ground truth" for claiming substantial equivalence is based on:
  • Engineering principles and biomechanical testing: The device's ability to withstand anticipated physiological loads and perform its mechanical function.
  • Performance of predicate devices: The established safety and effectiveness of similar, legally marketed spinal systems.
  • Material specifications: The known properties and biocompatibility of stainless steel and titanium.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" for an AI algorithm associated with this mechanical device.

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

• Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of the 510(k) Assessment Approach:

The FDA's review for this device (K982987) focused on substantial equivalence. This means the manufacturer (Synthes) demonstrated that their new "Posterior Universal Spinal System" is as safe and effective as a legally marketed predicate device(s) that already had FDA clearance. The key elements for this determination mentioned in the summary are:

• Identification of Predicate Device(s): The submission states, "This system is identical to previously cleared Synthes spinal systems."
• Performance Testing: "supported by testing which satisfies the requirements of posterior thoracolumbar and sacral fixation." While specific details of this testing (e.g., fatigue, static strength) are not in the public summary, such tests would have been performed and submitted to the FDA to demonstrate equivalence in mechanical performance.
• Material Equivalence: The use of "stainless steel or titanium" which are well-established materials for spinal implants.
• Indications for Use Equivalence: The stated indications for use are carefully compared to those of the predicate device(s) to ensure they fall within acceptable parameters for substantial equivalence.

In essence, for this type of device, the "study" proving acceptance criteria typically involves benchtop mechanical testing, material characterization, and a detailed comparison of design and indications for use against predicate devices, rather than clinical trials with patient populations or complex AI performance metrics.

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