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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.

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The First Ray Flip Button Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for All Digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

The Flip Button Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone. The device is deployed through a bicortical drill hole and secured on the far cortex.

The provided document is a 510(k) summary for a medical device (Flip Button Suture Anchor) and does not describe a study involving an AI/software device that generates performance metrics for acceptance criteria. Instead, it describes a non-clinical testing approach to demonstrate substantial equivalence to predicate devices. Therefore, most of the requested information regarding AI/software performance metrics and ground truth establishment is not applicable.

However, I can extract information related to the acceptance criteria and the study performed for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states "All necessary testing has been performed for the worst-case Flip Button Suture Anchor". It does not specify the exact sample size used for the test set (different units of the Flip Button Suture Anchor tested) nor details on data provenance (e.g., country of origin, retrospective/prospective).
• The testing was non-clinical, conducted on "test units representative of finished devices" and "bone analog material".

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

• Not applicable. This was a non-clinical, mechanical performance study, not one requiring expert human interpretation of data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This was a non-clinical, mechanical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a non-clinical, mechanical performance comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a physical medical device (suture anchor), not an algorithm or software. The study evaluated its mechanical performance.

7. Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" was established by measured mechanical properties (static pullout strength) compared against the performance of a predicate device in a controlled laboratory setting using bone analog material.

8. Sample Size for the Training Set:

• Not applicable. This was a non-clinical performance study of a physical device, not an AI/software requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set was used.

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The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

The Bicortical Fixation Screw & Washer Nut System consists of screws in various diameters and lengths that mate with a washer nut to achieve bicortical fixation.

The provided text describes a medical device, the "Bicortical Fixation Screw & Washer Nut System," and its clearance by the FDA. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and nonclinical (mechanical) testing. It explicitly states, "Clinical data are not needed to support the safety and effectiveness of the subject device."

Therefore, I cannot provide the requested information regarding AI/ML-related acceptance criteria, clinical study details, sample sizes, ground truth establishment, or expert involvement. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices, which this medical device (a bone screw system) is not.

Here's what I can extract based on the type of study described, even though it's not a clinical AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a table with reported performance. Instead, it relies on demonstrating substantial equivalence through nonclinical mechanical testing.

• Static pullout testing: Performed in bone analog material on the worst-case Bicortical Fixation Screw & Washer Nut. |
  | Material Biocompatibility: Conforms to established standards for permanent implants | "The subject and predicate devices are manufactured from titanium alloy conforming to ASTM F136. This is a material with a long history of biocompatibility and use in previously cleared permanent implants." |
  | Design/Function Equivalence: No new issues of safety or effectiveness introduced | "The mechanical testing demonstrates that this minor difference in technology [how compression is achieved] introduces no new issues of safety or effectiveness." Functionally, both aim to achieve compression of fracture fragments. "The Bicortical Fixation Screw & Washer Nut System is substantially equivalent...with respect to its indications for use, material, design, and function." |

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

• Test Set Sample Size: Not explicitly stated numerically. The testing was performed on "test units representative of finished devices." This typically implies a limited number of samples for mechanical testing, not a large patient cohort.
• Data Provenance: The testing was "nonclinical," meaning it was conducted in a lab environment on bone analog material, not on human patients. The country of origin for the testing data is not specified but would likely be the USA where First Ray LLC is located. The study was essentially prospective in terms of the specific devices being manufactured and tested.

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

• This question is not applicable. There was no clinical ground truth established by experts for this nonclinical mechanical testing. The "ground truth" for mechanical testing is derived from established engineering principles and material science standards.

4. Adjudication method for the test set

• This question is not applicable. There was no expert "adjudication" in the sense of clinical review or diagnosis. Mechanical testing results are typically analyzed against predefined engineering specifications.

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 MRMC clinical study was performed, as the device is a bone fixation system and not an AI/ML diagnostic or assistive tool for human readers.

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

• This question is not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's evaluation was mechanical performance data gathered through specific engineering tests (torsion and static pullout) in a bone analog environment, compared against the known performance characteristics of the predicate device (Synthes Cortex Screws). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• This question is not applicable. There was no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There was no "training set" or corresponding ground truth for an AI/ML context.

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The First Ray Internal Bone 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 Internal Bone Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.

The provided text is a 510(k) summary for the First Ray Internal Bone Staple System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain acceptance criteria for an AI/ML powered device or a study proving its performance against such criteria.

The document states:
"Clinical data were not needed to support the safety and effectiveness of the subject device."
"The Internal Bone Staple System performance was characterized through static pullout testing in bone analog material and static and fatigue four-point bend testing per ASTM F564-10 (2015) with a side-by-side comparison to the predicate device."

Therefore, I cannot provide the requested information for an AI/ML powered device based on the given text. The device is a physical bone staple system, and its evaluation relies on mechanical testing against predicate devices.

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