Search Results

The Stealth Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

• Arthrodesis in hand or foot surgery ●
• Mono or bi-cortical osteotomies in the foot or hand ●
• Fracture management in the foot or hand ●
• . Distal or proximal metatarsal or metacarpal osteotomies
• Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc. .

The Stealth Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.

This document is a 510(k) premarket notification for the "Stealth Staple System," a metallic bone fixation appliance. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and nonclinical testing.

This document DOES NOT describe an AI/ML device or a study involving human readers and AI assistance. Therefore, I am unable to answer questions 2, 3, 4, 5, 6, 7, 8, and 9. These questions are specifically designed for AI/ML device submissions, which incorporate data provenance, expert ground truth, multi-reader studies, and training/test set details.

However, I can provide information based on the nonclinical testing described in the document for the "Stealth Staple System."

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

The document states: "The results of this testing demonstrate that the Stealth Staple System met the predetermined acceptance criteria." However, specific numerical acceptance criteria and the corresponding reported performance values are not provided in this document. The document only lists the types of tests performed.

Explanation: The document mentions that the nonclinical testing (Static Testing, Fatigue Testing, Pullout Testing) was performed using the "same methods performed on the predicate device in submission K153622." It concludes that the device "met the predetermined acceptance criteria." However, it does not disclose what those predetermined acceptance criteria were (e.g., minimum load for static testing, cycles for fatigue testing, or force for pullout testing), nor does it disclose the actual numerical results achieved by the Stealth Staple System in these tests.

Summary for AI/ML Specific Questions (not applicable to this document):

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is a medical device, not an AI/ML diagnostic.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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 (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

The modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving a device meets these criteria. The document is a 510(k) premarket notification for a medical device (KATOR Suture Anchor) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's what I can extract and why some parts of your request cannot be answered from this text:

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

The document states: "The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities." However, it does not explicitly list the specific acceptance criteria or the numerical results of the performance tests. It only lists the types of tests performed.

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

This information is not provided in the document. The text mentions "verification tests" and "testing as summarized in the Design Control Activities Summary" but does not detail the sample sizes or the provenance of the test data.

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 not applicable as the document describes mechanical testing of a medical implant (suture anchor), not an AI or diagnostic imaging device that would typically rely on expert-established ground truth.

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

This is not applicable for the same reason as point 3.

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 is not applicable as the document is about a mechanical medical device, not an AI or diagnostic imaging system involving human readers.

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

This is not applicable as the device is a physical suture anchor, not an algorithm.

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

This is not applicable in the context of mechanical device testing. The "ground truth" for mechanical performance is typically defined by engineering specifications and standards.

8. The sample size for the training set

This is not applicable as the document describes a mechanical medical device, not a machine learning model that would have a training set.

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

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

Summary of what can be extracted from the document:

• Device Name: KATOR Suture Anchor
• Purpose of Study: Verification testing to demonstrate that the modified KATOR Suture Anchor met pre-determined acceptance criteria and introduced no new issues of safety or effectiveness compared to its predicate device (K152236).
• Types of Tests Performed:
  • Static Performance Testing
  • Dynamic Performance Testing
  • Limulus Amebocyte Lysate (LAL) testing for endotoxin levels.
• Outcome of Testing: "The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities."
• Ground Truth (Implicit): For mechanical tests, the ground truth would be defined by the engineering specifications and relevant ASTM or ISO standards for suture anchors. For endotoxin levels, it's defined by acceptable limits established using LAL testing.
• Data Provenance: Not specified, but generally, such testing for 510(k) submissions is performed in a controlled laboratory environment.

To provide the detailed information you requested (specific acceptance criteria, numerical performance data, sample sizes, etc.), you would need access to the "Design Control Activities Summary" mentioned in the document, which is not included in the provided text.

Ask a specific question about this device