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The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft, when affixed to the lumbosacral spine, and intended to be removed after solid fusion is attained.

The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacraViliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.

As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

The purpose of the premarket notification is to add a pediatric PRC (Plate-Rod Combination) and downsized hooks to the components intended for use with AcroMed's ISOLA Spine System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.

The provided text describes a 510(k) premarket notification for the "PEDIATRIC PRC for use with the ISOLA Spine System." This document is not a clinical study report but rather a regulatory submission for device clearance. Therefore, it does not contain the typical structure of a study that establishes acceptance criteria and then proves the device meets them through clinical data.

Instead, the performance data section states: "Static and fatigue testing were conducted to characterize the performance of the devices." This implies mechanical or laboratory testing, which is common for implantable devices to ensure their structural integrity and durability. The acceptance criteria for such tests would be internal to the manufacturer's design specifications for strength, fatigue life, and other mechanical properties, and would be compared against validated methods or industry standards for similar devices.

The document then focuses on establishing "Substantial Equivalence" to previously cleared devices (K920392, K952236, and K962984) based on material, design, and intended use. This is a regulatory pathway for devices that are similar in technology and indications to existing legally marketed devices, rather than a demonstration of clinical efficacy and safety through new clinical studies.

Therefore, many of the requested points cannot be answered from the provided text, as it doesn't describe a clinical study with human subjects, ground truth establishment, or expert adjudication.

Here's a breakdown of what can be inferred or directly stated from the text regarding acceptance criteria and performance, with explanations for what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not provide specific numerical acceptance limits for static and fatigue testing. It simply states that testing was conducted to "characterize" performance and that the device is "substantially equivalent" to predicate devices, implying that its performance is acceptable within the context of those predicates.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not applicable for a clinical test set from this document. The "tests" mentioned are mechanical static and fatigue tests. The sample size for these mechanical tests is not specified.
• Data Provenance: Not applicable for a clinical test set. The mechanical testing was likely conducted by the manufacturer (AcroMed Corporation).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not a clinical study requiring ground truth established by medical experts. The "ground truth" for mechanical testing would be engineering specifications and industry standards.

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

• Not applicable as this is not a clinical study involving human readers or interpretation of medical data. Adjudication methods are relevant for subjective assessments, which are not described here.

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. This is a 510(k) submission for a spinal implant, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance are not relevant.

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

• No. This is a 510(k) submission for a physical medical device (spinal implant), not an algorithm or software.

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

• For the mechanical performance, the "ground truth" would be established by engineering principles, industry standards (e.g., ASTM standards for biomechanical testing of spinal implants), and the performance characteristics of the predicate devices. It is not clinical "ground truth" like pathology or outcomes data.
• The "truth" for substantial equivalence is based on comparing the new device's design, materials, manufacturing, indications for use, and performance to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. This device 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:

• Not applicable. (See #8)

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