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The StealthFix Intraosseous Fixation 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 StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.

This document describes the 510(k) summary for the StealthFix Intraosseous Fixation System. It outlines the device, its intended use, and its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K220181). This typically means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical or performance data for a diagnostic device. The evaluation primarily relied on engineering analysis, materials comparison, and cadaveric testing.
• Data Provenance:
  • Engineering Analysis: Based on design comparisons and calculations.
  • Cadaveric Testing: Implied to be prospective testing carried out for usability evaluation.
  • Endotoxin Testing: Laboratory testing on device samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in the context of this 510(k) summary, as it does not involve a diagnostic algorithm requiring expert-established ground truth on a test set. The assessment is based on physical and engineering properties, and direct comparison to a predicate device.
• Qualifications of Experts: Not specified or relevant for this type of submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The evaluation is not based on interpreting results from a test set that requires expert adjudication.

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

• MRMC Study: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: The "ground truth" in this context is established through:
  • Material Specifications: Conformance to ASTM standards for Ti-6Al-4V alloy and Stainless Steel.
  • Design Documentation: Verification of identical staple designs and comparison of screw designs to the predicate device.
  • Engineering Principles: Analysis demonstrating mechanical equivalence or non-inferiority of new screw designs.
  • Performance Standards: Meeting endotoxin limits.
  • Functional Assessment: Cadaveric testing for usability.
  • Predicate Device Performance: The safety and effectiveness of the predicate device (K220181) serves as the benchmark.

8. The Sample Size for the Training Set

• Training Set Sample Size: 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

• Ground Truth Establishment for Training Set: Not applicable. This device does not involve a "training set."

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The StealthFix Intraosseous Fixation 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 StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), 3.5mm(small) and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and 20mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The system provides accessory instruments designed for preparation of the implant site and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile and non-sterile for single use. The instruments are provided non-sterile, reusable or non-sterile, single use and must be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "StealthFix Intraosseous Fixation System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/software device.

Therefore, many of the requested categories related to AI/software performance studies are not applicable to this type of regulatory submission. This document describes a traditional hardware medical device.

Here's the breakdown based on the provided information, with explanations for why certain sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide specific quantitative acceptance criteria or device performance metrics in the way an AI/software device would (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through material, design, and mechanical properties.

   Acceptance Criteria Category	Specific Criteria (Not explicitly stated as quantitative values for a software device)	Reported Device Performance
   Biocompatibility	Endotoxin limit ≤ 20 EU per device	Met the Endotoxin limit
   Mechanical Properties	Not creating a new worst-case for:	Engineering analysis performed; modified staples/screws do not create a new worst case for these tests.
   	- Static and dynamic 4-point bend testing (staples)
   	- Pullout force (staples) (ASTM F564)
   	- Torsional strength (screws) (ASTM F543)
   	- Pullout strength (screws) (ASTM F543)
   	- Insertion performance (screws) (ASTM F543)
   Substantial Equivalence	Equivalence in intended use, indications, material, design, sizes, mechanical properties to predicate device.	Achieved; differences do not raise new safety/effectiveness questions.

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a hardware device. The "tests" mentioned were engineering analyses and biocompatibility testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described for this hardware device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reason as above.

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. This device is an orthopedic fixation system, not an AI/software diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance relies on engineering principles and biocompatibility standards, not clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set: Not applicable. No training set is involved for this hardware device.

9. How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.

Study Proving the Device Meets Acceptance Criteria (as described in this 510(k) submission):

The primary "study" that proves this device meets the regulatory acceptance criteria for 510(k) clearance is a demonstration of Substantial Equivalence to a legally marketed predicate device (K163440 - Stealth Staple System, First Ray LLC).

• Non-Clinical Testing:

  • Biocompatibility: Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161, and USP 85. The results met the endotoxin limit of ≤20 EU per device.
  • Mechanical Performance: An engineering analysis was conducted. This analysis ensured that modifications made to the subject device (increased internal thread length in staple posts, non-cannulated screws) did not create a new worst-case scenario for several mechanical tests that would typically be performed on such devices. These tests include:
    • Static and dynamic 4-point bend testing (for staples)
    • Pullout force (for staples, according to ASTM F564)
    • Torsional strength (for screws, according to ASTM F543)
    • Pullout strength (for screws, according to ASTM F543)
    • Insertion performance (for screws, according to ASTM F543)

• Clinical Testing: The submission explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device." This is a common aspect of 510(k) submissions where non-clinical data is deemed sufficient to establish equivalence.

• Conclusion: The submission concludes that "The StealthFix Intraosseous Fixation System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise different types of safety and effectiveness questions." This statement is the ultimate proof that the device, for the purposes of this FDA submission, "meets the acceptance criteria" of being substantially equivalent to a predicate.

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