Search Results

The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. This premarket notification is being submitted to reflect the addition of a spinal system fabricated from stainless steel.

The provided text describes a medical device submission (K061563) for the EBI® Array® Spinal System. However, it does not contain the specific information requested regarding acceptance criteria, a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training set.

The document primarily focuses on the substantial equivalence of the EBI® Array® Spinal System to existing predicate devices based on:

• Intended Use and Indications: The indications for use are clearly stated for various spinal conditions.
• Technological Characteristics: The submission highlights that the proposed system includes a new stainless steel version.
• Basic Principles of Operation: It asserts that the fundamental principles remain the same as predicate devices.
• Performance Testing (Mechanical): It states that mechanical testing was conducted and demonstrates conformity to design specifications, with requirements based on predicate devices. It explicitly mentions that the "worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance."

Here's a breakdown of what can be extracted and what is missing based on your specific questions:

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

• Acceptance Criteria: The document implies that acceptance criteria were established through "design specifications" which were "based on those of the previously cleared predicate devices." However, the specific criteria themselves (e.g., specific load values, fatigue cycles, displacement limits) are NOT provided.
• Reported Device Performance: The document states that "The results of testing conducted demonstrate that the worst case of the proposed system adequately meets the requirements established in design specifications for its mechanical performance." However, the specific performance data (e.g., actual load to failure, number of cycles survived) are NOT provided.

Therefore, a table cannot be constructed with specific values from this document. The information is high-level and qualitative rather than quantitative.

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

• Sample Size: The document mentions "mechanical testing" but does not specify the sample size (e.g., number of implants tested).
• Data Provenance: This is a mechanical engineering test, not a clinical data study. Therefore, concepts like country of origin or retrospective/prospective data are not applicable. The testing would have been conducted in a lab environment.

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 is a mechanical engineering product. There are no "experts" in the clinical sense (like radiologists) establishing ground truth for the test set. Instead, there would be engineers designing the test protocols, conducting the tests, and analyzing the results against established engineering standards or internal specifications. No specific number or qualifications of such engineers are provided.

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

• This concept is not applicable to mechanical testing of a medical device. Adjudication methods are typically used in clinical studies or image interpretation where human judgment, and potential discrepancies, need to be resolved.

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 MRMC study was done. This device is a physical spinal implant, not an AI or imaging diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are irrelevant to this submission.

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

• No standalone (algorithm-only) performance was done. Again, this is a physical implant, not a software algorithm.

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

• For mechanical testing, the "ground truth" would be established by engineering design specifications and recognized mechanical testing standards (e.g., ASTM, ISO standards applicable to spinal implants). The device's performance is tested against these predefined thresholds or comparison to predicate device performance. The document only states "design specifications were established based on those of the previously cleared predicate devices."

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission refers to mechanical testing.

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 submission.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (spinal implant). The information you're asking for (especially regarding AI/ML studies, ground truth, expert adjudication, etc.) is not relevant to this type of device and therefore is not present in the submission. The assessment of this device for substantial equivalence relies on comparing its mechanical properties and intended use to existing, legally marketed predicate devices through engineering testing.

Ask a specific question about this device