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Iconix Speed Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

The Iconix Speed Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable self-punching inserter. The device is composed of a braided polyester anchor body that contains two or three working sutures. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix Speed Anchors are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

The provided FDA 510(k) clearance letter and summary for the Iconix Speed Anchor does not describe a study that involves software performance, AI algorithms, or human-in-the-loop assessments. Instead, it describes mechanical and biological performance testing for a physical medical device (bone anchor).

Therefore, I cannot provide details for most of your requested points, as they are specific to AI/software device studies.

However, I can extract the information related to the device's performance testing and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and the Reported Device Performance

The 510(k) summary states that "Results of performance testing for the Iconix Speed Anchor device concluded that the device performed comparably to the predicate device in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix Speed Anchor met all requirements for its intended use."

However, the document does not explicitly state specific quantitative acceptance criteria (e.g., "pullout strength > X N") or the exact reported performance values for the Iconix Speed Anchor in these tests. It only states that the device performed "comparably" to the predicate.

The following information cannot be provided as the provided document describes a physical medical device (bone anchor), not an AI/software device study.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to physical units of the device subjected to mechanical and biological testing, not a dataset for an AI model. The document does not specify the number of samples for each mechanical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical performance is typically established through direct physical measurement under controlled conditions, not expert consensus.
4. Adjudication method: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical tests (insertion, cyclic, pullout), the "ground truth" is the measured physical performance of the device. For biological tests, it's compliance with ISO standards. For usability, it's observation in cadaveric models.
8. The sample size for the training set: Not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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