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The tangoRS™ is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.

The tangoRS™ consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Crosslinks are offered in four lengths. The purpose of this submission is to add components (a screw size and crosslink options) and two indications for use.

The provided 510(k) summary for the tangoRS™ multifunctional posterior system describes its performance through mechanical testing. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of individual patients or clinical cases for a test set. The performance evaluation is based on mechanical testing of "worst case tangoRS™ constructs." The exact number of constructs tested is not provided, but it would typically involve multiple samples for each test condition to ensure reproducibility.
• Data Provenance: The data is generated from in-vitro (benchtop) mechanical testing, not from patient-derived data. Therefore, there's no country of origin for clinical data, and it is not retrospective or prospective in the clinical sense.

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

This information is not applicable to this type of submission. Mechanical testing does not involve human experts establishing "ground truth" on patient data. The "ground truth" for mechanical testing is established by the specified ASTM F1717 standard and the performance of predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as the study is mechanical testing, not a clinical study involving human judgment that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission relies on mechanical bench testing, not clinical studies involving human readers.

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

This is not applicable. The device is a physical medical implant (pedicle screw system), not an algorithm or software. Therefore, there's no concept of "standalone performance" in the context of an algorithm. The performance described is inherent to the device's physical and mechanical properties.

7. Type of Ground Truth Used

The "ground truth" used for this type of device and submission is based on:

• ASTM F1717 standards: These provide the accepted methodology and criteria for testing spinal implant constructs.
• Performance of predicate devices: The tangoRS™ system is compared against the mechanical performance of previously cleared predicate devices (flamenco™ {K102853}, CD HORIZON® {K031655/K041460}, Expedium {K041119/K062196}, tangoRS™ {K052385}). The implicit "ground truth" is that if the new device performs "as well as or better than" these established devices under standardized testing, it is considered safe and effective.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design of the tangoRS™ system is based on established engineering principles and knowledge gained from predicate devices, but there isn't a "training set" of data in the machine learning sense.

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

This is not applicable as there is no "training set" for this type of device and study. The physical design and materials are chosen based on known biomechanical requirements and historical performance of similar devices.

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The Coral ™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain 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 purpose of this submission is for additional sizes and designs of polyaxial screws for the Coral ™ Spinal System. The Coral ™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies. The Coral ™ Spinal System implant components are fabricated from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136.

This is a 510(k) premarket notification for a medical device, specifically the Coral™ Spinal System. It is an application for additional sizes and designs of polyaxial screws, indicating it's an update to an existing device (K041592). The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a novel study proving specific acceptance criteria for a new AI/software device.

Therefore, most of the requested information cannot be extracted from this document because it describes a hardware spinal implant system, not an AI/software device. The document centers on demonstrating that the new components are substantially equivalent to previously cleared devices based on materials, intended use, and mechanical testing, not on clinical performance metrics with an AI component.

Here's what can be gathered, with answers to points that are applicable:

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

• Not applicable for an AI/software device as this is a hardware spinal implant.
• The core of the "acceptance criteria" for this submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing similarities in:
  • Indications for use
  • Operating principle
  • Materials
  • Surgical techniques and equipment type
  • Manufacturing environment
  • Sterilization process
  • Packaging configurations
  • Mechanical testing (mentioned generically as a reason for substantial equivalence, but no specific criteria or results are provided in this summary).

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

• Not applicable. This document describes a physical medical device (spinal implant). The "test set" for this type of device typically refers to a set of mechanical tests performed in a lab, not a clinical dataset in the context of AI/software. There is no usage of terms like "test set," "data provenance," or "country of origin of data" in this context.

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)

• Not applicable. See point 2. Ground truth establishment with experts is not relevant for this type of hardware device submission.

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

• Not applicable. See point 2.

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/software device.

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

• Not applicable. This is not an AI/software device.

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

• Not applicable directly in the AI/software sense. For a physical device, "ground truth" might refer to established engineering standards or biomechanical principles used to design and test the device. The document mentions "mechanical testing" generally, which would be compared against such standards, but no specific ground truth type is detailed.

8. The sample size for the training set

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

Summary of Device Performance (from the perspective of a hardware device):

The document states that the additional components for the Coral™ Spinal System are substantially equivalent to the predicate device (K041592). This claim is supported by:

• Mechanical Testing: Although no specific results or criteria are provided in this summary, the document explicitly mentions "mechanical testing" as evidence for substantial equivalence, alongside the use of "established, known materials." This implies that the new components underwent mechanical tests to demonstrate performance comparable to the predicate device and relevant industry standards.
• Material Composition: The components are fabricated from "medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 and ISO 5832-3," which indicates adherence to recognized material standards for biocompatibility and strength.
• Design and Function: The components maintain the same indications for use, operating principle, surgical techniques, manufacturing environment, sterilization process, and packaging configurations as the predicate device.

The FDA's decision to clear the device (K070962) with a finding of substantial equivalence indicates that the submitted evidence and performance data (including implied mechanical testing data not detailed in this summary) were deemed sufficient to meet the regulatory requirements for this type of hardware medical device.

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