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The Streamline MIS Cannulated System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the 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 (L3-S1) with removal of the implants after the attainment of a solid fusion.

The Streamline MIS Cannulated System consists of rods, pedicle screws, connectors, and set screws used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline MIS Cannulated System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lower thoracic and/or lumbar spine during open or percutaneous spinal procedures. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, Rods and Connecting components are comprised of Titanium Alloy per ASTM F 136.

The provided text describes a 510(k) summary for the Streamline MIS Cannulated System, a medical device for spinal fixation. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical performance testing. It refers to "testing" and "test results" in a general sense. When a 510(k) submission states that engineering tests were run in accordance with a specified ASTM standard, the sample sizes are taken from that standard. However, the exact sample sizes used for each test are not explicitly detailed in this summary.
• Data Provenance: The data is generated from mechanical laboratory testing performed by Pioneer Surgical Technology. The data provenance is internal to the manufacturer. It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the typical sense for patient data.

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

• This information is not applicable to this type of submission. The "ground truth" for mechanical testing is established by objective measurements against engineering standards (ASTM F1717) and internal protocols, not by expert consensus or interpretations of patient data.

4. Adjudication Method for the Test Set

• This information is not applicable to this type of submission. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human interpretation or assessments, not for mechanical laboratory testing.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for a spinal fixation device, and the evaluation is based on mechanical substantial equivalence, not on the interpretative performance of a diagnostic algorithm or the effectiveness of human readers.

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

• No, a standalone study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of algorithm-only performance is not relevant.

7. Type of Ground Truth Used

• The "ground truth" used for this submission is based on established engineering standards (ASTM F1717) for mechanical properties and internal protocols for specific component performance. The performance of the Streamline MIS Cannulated System was compared to the performance of predicate devices against these established benchmarks.

8. Sample Size for the Training Set

• This information is not applicable. There is no "training set" in the context of this 510(k) submission, as it is not an AI/ML algorithm or a diagnostic device that requires training on data. The device's design and manufacturing processes are validated, and its performance is verified through physical testing.

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

• This information is not applicable, as there is no "training set" for this type of medical device submission.

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The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The Quantum Spinal System components are non-cervical spinal fixation devices. Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.

The provided 510(k) summary for the K080518 Quantum Spinal System does not contain information on acceptance criteria for a device, diagnostic or AI algorithm, nor a study proving it meets such criteria. Instead, it describes a medical device (spinal fixation system) and its intended use, material, and regulatory classification.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance data (e.g., mechanical testing) for spinal implants, rather than clinical performance data from studies involving human subjects in the way an AI/diagnostic device would be evaluated.

Therefore, I cannot provide the requested information in the table format or answer the specific questions related to AI/diagnostic device evaluation, as these details are not present in the provided text.

The "Performance Data" section states: "Testing per recognized ASTM standards was presented." This refers to laboratory-based mechanical and materials testing according to established engineering standards for medical implants. These tests usually evaluate properties like fatigue strength, pull-out strength, and corrosion resistance, which is different from a diagnostic performance study.

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