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Spinal fixation 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 or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Spinal fixation system is mainly constituted by pedicle screw, reduction pedicle screw, Set screw, Spine Hook, Rod and Transverse linking pole assembly. Through using the assembly of the screws, rods and/or poles, there will be established a firm frame structure on the Spinal (conforming to the bio-mechanics principle). The components of the system include: pedicle screw, reduction pedicle screw, set screw, spine hook, rod and transverse linking pole assembly and so on. According to the different specification of the rod's diameter and the different usage on the spinal segments, the system is classified: J2X03, J2X04, J2X07..

Here's an analysis of the provided text regarding the acceptance criteria and study for the described medical device:

The provided document (K161151) is a 510(k) summary for a "Spinal fixation system." It describes a traditional clearance pathway where the device is shown to be substantially equivalent to a legally marketed predicate device (Devine Spinal System K111690). This type of submission relies heavily on similarity in design, materials, and performance data to the predicate, rather than establishing de novo safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study provided to demonstrate the device meets acceptance criteria is primarily a non-clinical bench testing study focused on mechanical and material properties, along with a rationale for biocompatibility based on material standards and prior use.

• Mechanical Testing:

  • Tests conducted: Static compression bending test, Dynamic compression bending test, Static torsion test.
  • Standard followed: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
  • Results: For all mechanical tests, the reported performance is that the testing results show "no statistically significant difference" between the proposed device and the predicate device's performance. This implies the acceptance criterion was equivalence or non-inferiority to the predicate device's established mechanical properties.

• Biocompatibility Testing:

  • Rationale provided: The device is made of Ti-6Al-4V, a material conforming to ASTM F136. The document states this material has been "employed successfully in human implant applications in contact with soft tissue and bone for over a decade" and has been used as a "control material in Practice F 981." This serves as the "proof" that the material is biocompatible, rather than new primary biocompatibility testing specifically for this device.

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

• Sample Size for Test Set: The document does not explicitly state the exact sample size for the mechanical tests (e.g., how many screws, rods, or construct assemblies were tested for each mechanical property). It refers to "two sample groups" (presumably proposed device vs. predicate) for comparison.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the testing itself, but the manufacturer (CANWELL MEDICAL CO., LTD.) is based in China. The predicate device manufacturer (Changzhou Orthmed Medical Instrument Co., Ltd) is also likely Chinese.
  • Retrospective or Prospective: The bench testing would be considered prospective for the specific tests performed on the proposed device, but the comparison relies on established data/performance of the predicate device.

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

Given this is a 510(k) submission for a physical implant (spinal fixation system) based on substantial equivalence and primarily on bench testing, the concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus on image interpretation) is not applicable in the same way.

• Ground Truth for Mechanical Tests: The "ground truth" is effectively adherence to established ASTM standards and the performance characteristics of the predicate device. The experts involved would be engineers or testing personnel qualified to conduct and interpret the mechanical tests and compare them to the predicate's specifications/performance data. Their specific number or qualifications are not detailed in this document.
• Ground Truth for Biocompatibility: The "ground truth" is the established biocompatibility of the ASTM F136 Titanium alloy, as recognized by regulatory bodies and scientific literature.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of mechanical and material testing. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretations (e.g., in diagnostic studies). Here, the comparison is objective (numerical results from mechanical tests) and against a known standard or predicate performance.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study assesses human performance, often with and without AI assistance, and is common in diagnostic imaging devices. This device is a physical implant, not a diagnostic tool with human interpretation.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was done. This concept is relevant for AI algorithms. The device described is a physical medical implant (spinal fixation system).

7. Type of Ground Truth Used

• For Mechanical Performance: The ground truth is established through industry-recognized ASTM standards (ASTM F1717) and the established performance characteristics of the legally marketed predicate device (K111690).
• For Biocompatibility: The ground truth is based on material standards (ASTM F136) and the documented history of safe use of the material in medical implants.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, material science, and the existing predicate device, but not through a "training set" of data for an algorithm.

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

• Not Applicable (as there is no training set for an algorithm). The "ground truth" for the device's design and manufacturing is derived from established engineering principles, material science knowledge, and the performance history and specifications of the predicate device.

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