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The WASTON General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.

The WASTON General Spinal System consists of Fixed-Angle Screws, Fixed-Angle Reduction Screws, Rods, Crosslink and Set Screws. The proposed general spinal system is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The document provided is a 510(k) premarket notification for the WASTON General Spinal System, identifying it as a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Trauson General Spinal System, K082617) through non-clinical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests conducted per ASTM F1717-14. It only states that "Non clinical tests were conducted." Typically, these tests involve multiple samples for each component or construct configuration, but the precise numbers are not disclosed in this summary.
• Data Provenance: The device manufacturer is Changzhou Waston Medical Appliance Company, Limited, located in China. Therefore, the non-clinical test data was likely generated in China, associated with the manufacturer or a contracted testing facility. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

• This information is not applicable to this submission. The "test set" in this context refers to non-clinical, mechanical performance testing of a spinal implant system. The "ground truth" is established by adherence to a recognized standard (ASTM F1717-14) and the physical properties of the materials and device design, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

• This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting human-read data or clinical endpoints. For mechanical testing against a standard, the results are objectively measured and compared to the standard's pass/fail criteria, often requiring a pass for all tested samples.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for AI-powered diagnostic or interpretive devices, which is not the case for a spinal implant system.

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

• No, a standalone algorithm performance study was not done. This device is a physical spinal implant system, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study would not be relevant.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is typically defined by established engineering standards and material specifications. The device's performance is compared against the requirements and methodologies outlined in:
  • ASTM F1717-14 for mechanical performance (static compression bending, dynamic compression bending, static torsion).
  • ASTM F136-02a for material composition and properties.
  • ISO 17665-1: 2006 for sterilization validation.

8. The Sample Size for the Training Set

• This information is not applicable to this submission. "Training set" refers to data used to train machine learning models. As this device is a physical spinal implant system and does not involve AI or algorithms, there is no training set in this context.

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 device.

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