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The Spinal Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The Spinal Fixation System consists of screws, rods, transverse bar assembly, set screws. It is made of titanium Alloy (Ti6AI4VELI), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium 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.

This document is a 510(k) summary for a medical device (Spinal Fixation System) and outlines its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-assisted system's performance, as the request implies.

The document discusses substantial equivalence for a spinal fixation system, which is a medical implant, not an imaging or diagnostic device. The "acceptance criteria" discussed are related to performance testing verifying the physical properties and safety of the implant, not the diagnostic accuracy of an algorithm.

Therefore, I cannot provide the information requested based on the provided text. The prompt asks for details about a study proving a device meets acceptance criteria, specifically on aspects like sample size, ground truth, expert adjudication, MRMC studies, and training set details, which are relevant to diagnostic or AI-based devices. The provided document concerns a physical implant called a "Spinal Fixation System" and its regulatory clearance via a 510(k) submission, demonstrating substantial equivalence to a predicate device based on material, intended use, and mechanical testing.

The document does not contain information about:

1. A table of acceptance criteria for diagnostic performance.
2. Sample sizes for test sets in a diagnostic context.
3. Number of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Types of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, the document focuses on:

• Device Description: Made of titanium alloy, non-sterile, sterilized via autoclave.
• Intended Use: Posterior, non-cervical, pedicle fixation for specific spinal conditions.
• Technological Characteristics Comparison: Comparing the subject device (Spinal Fixation System) to a predicate device (General Spinal System K122994) in terms of product code, regulation, intended use, material, test items (static compression bending, static torsion, dynamic compression bending), test standard (ASTM F1717), how supplied, sterilization method, single use, and prescription/OTC use.
• Performance Data: Mentions "sterility and performance testing" and "Test data and report information are included in this submission," but does not detail the specific acceptance criteria or results of these tests in the provided text. These tests would typically involve mechanical strength, fatigue, and material biocompatibility, not diagnostic accuracy.

To answer your question, information relevant to diagnostic or AI-assisted devices would need to be present in the provided text, which it is not.

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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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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin 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 Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The provided text describes the Lanx Spinal Fixation System, primarily focusing on its intended use, technological characteristics, and its substantial equivalence to predicate devices, which led to its FDA clearance. However, it does not include a detailed study with acceptance criteria and reported device performance in the way a clinical study or performance verification test report would.

The document is a 510(k) summary, which is a premarket notification to the FDA. For devices like spinal fixation systems, the primary "acceptance criteria" for 510(k) clearance often revolve around demonstrating substantial equivalence to a predicate device, as opposed to proving novel clinical efficacy or meeting specific statistical performance thresholds in a clinical trial.

Based on the provided text, here's a breakdown of the requested information, noting what is present and what is absent:

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

The document does not provide a table with quantitative acceptance criteria and reported device performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy for a diagnostic device, or specific load-bearing limits for an orthopedic implant compared to a defined standard).

Instead, the "acceptance criteria" are implied by the FDA's requirement for substantial equivalence. The performance reported is that "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

• Implied Acceptance Criterion: Demonstrate substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness.
• Reported Device Performance: "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

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

The document mentions "Performance testing and engineering analysis was performed and submitted to characterize the system." However, it does not specify the sample size used for these tests, nor does it detail the nature of the "test set" (e.g., whether it refers to physical prototypes, cadaveric samples, or data from human subjects). It also does not mention data provenance (country of origin, retrospective/prospective). This information is typically found in detailed test reports, not the 510(k) summary.

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)

This information is not applicable to this type of submission. The device is a spinal fixation system, not a diagnostic or AI-driven device requiring expert-established ground truths for performance evaluation during a 510(k) submission. The "ground truth" for a mechanical device is typically established through engineering standards and physical testing against those standards or predicate device performance.

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

This information is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review for establishing ground truth or evaluating diagnostic performance.

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

This information is not applicable. An MRMC study is typically for evaluating diagnostic imaging devices or AI algorithms that assist human readers. The Lanx Spinal Fixation System is an orthopedic implant and does not involve "human readers" or AI assistance in this context.

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

This information is not applicable. The device is a mechanical implant, not an algorithm.

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

For a mechanical implant, the "ground truth" during performance testing would typically be established through engineering standards, biomechanical testing protocols, and comparison to the known performance of predicate devices. The document refers to "Performance testing and engineering analysis" which implies these methods were used. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the engineering evaluation described.

8. The sample size for the training set

This information is not applicable. The device is a mechanical implant and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

Summary of Study (Based on Provided Text):

The "study" described is primarily focused on demonstrating substantial equivalence for a 510(k) premarket notification.

• Type of Study: Performance testing and engineering analysis (likely biomechanical testing, material testing, and design comparisons).
• Purpose: To characterize the system and demonstrate that it is as safe and effective as identified predicate devices.
• Key Finding: "The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."
• Absence of Detail: The 510(k) summary does not provide specific quantitative results, detailed test methodologies, sample sizes for testing, or information about expert involvement in establishing "ground truth" because these are not typically required at a high level in the summary document for this type of device. The FDA's clearance is based on the comprehensive testing performed and submitted to them, which is abstracted in this summary.

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