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The A.I.M.™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.

The A.I.M. ™ Suture Anchor is intended for use in the following applications:

Ankle: Mid-foot Reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction

The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl

The provided text includes a 510(k) summary for the A.I.M.™ Suture Anchor, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The study mentioned specifically details "anchor pull-out forces are equivalent or superior to a referenced predicate device", but it does not specify acceptance criteria or the full details of this study to meet your requested information.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission for substantial equivalence.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria and Reported Performance: The document states, "Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device." This indicates a performance metric (pull-out force) was evaluated and compared to a predicate, but neither specific numerical acceptance criteria nor the precise "reported device performance" values are provided.
• Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The document mentions "anchor pull-out forces" were tested, but it does not offer any details about the study design, such as:
  • Sample size for test set
  • Data provenance (country, retrospective/prospective)
  • Number or qualifications of experts
  • Adjudication method
  • MRMC comparative effectiveness study or effect size
  • Standalone algorithm performance
  • Type of ground truth used
  • Sample size for the training set
  • How ground truth for the training set was established

The submission's focus is on declaring substantial equivalence based on material history and general performance comparison to predicates, rather than presenting a detailed performance study with explicit acceptance criteria for a new type of device or an AI/software component, which is what your questions suggest.

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The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankart Repair
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.

The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.

The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus and Mini QuickAnchor Plus with Orthocord sutures), which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices.

The information provided includes:

• Device Description: Explains the nature of the anchors and sutures.
• Proposed Indications for Use: Specifies the medical conditions and anatomical locations for which the devices are intended.
• Safety Information: Mentions biocompatibility studies demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
• Substantial Equivalence: Lists predicate devices to which the current device is deemed substantially equivalent.

There is no mention of:

• A table of acceptance criteria and reported device performance in terms of clinical or technical metrics.
• Sample sizes for test sets, data provenance, or details about training sets.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).

Therefore, based on the input document, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this type of information is not present in the provided 510(k) summary. These summaries historically focus on demonstrating equivalence through design, materials, and intended use to predicate devices, rather than presenting detailed prospective clinical trial data with specific performance metrics and acceptance thresholds.

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