Search Results

The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.

The provided text describes a 510(k) premarket notification for a medical device called the "Superelastic Staple." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that no clinical studies were performed.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no clinical performance data for the device's efficacy or accuracy is presented in the provided document.

The document details the following regarding the device and its assessment:

• Device Name: Superelastic Staple
• Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
• Regulatory Class: Class II
• Product Code: JDR
• Indications for Use: The Superelastic Staple is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
• Predicate Devices:
  • Biopro Memory Staples® (K061798) from Biopro (Primary)
  • Memometal Memory Staples (Memoclip – Easy Clip – For Fusion) (K070031) from Memometal
  • ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis Staple (K142111) from Novastep
• Device Description: Made of NiTi alloy per ASTM F2063.
• Non-Clinical Tests Performed:
  • Static bending test (ASTM F564 – Annex 4)
  • Dynamic bending test (ASTM F564 Annex 1)
  • Axial pull-out strength (ASTM F564 Annex 2)
  • Transition temperature (ASTM F2004)
  • Corrosion susceptibility testing (ASTM F2129)
  • Cytotoxicity testing (ISO 10993-5:2009)
  • Acute Systemic Toxicity testing (ISO 10993-11:2006)
  • Chemical Characterization (ISO 10993-18:2005)
• Clinical Test Summary: "No clinical studies were performed."

Given this, I cannot fill out the requested table or answer the specific questions about clinical study design, acceptance criteria, sample sizes, expert involvement, or ground truth, as that information is not part of this 510(k) submission. This document relies solely on non-clinical (mechanical and biocompatibility) testing to demonstrate substantial equivalence.

Ask a specific question about this device

The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.

The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.

The design features of the CrossCLIP™ Implant System are summarized below:

• Implant Grade Nitinol (ASTM F2063-12) o
• O Various sizes to accommodate patient anatomy
• o One piece construction
• Barbs to resist pull-out O
• O Single use, sterile packaged instruments

The provided text is a 510(k) summary for the CrossCLIP™ Implant System, which is a medical device used for bone fixation. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document is a premarket notification from the FDA, confirming substantial equivalence to predicate devices, rather than a detailed scientific study report. It mentions "design verification analysis" and "performance testing" but does not provide the specifics of these tests as requested.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be fully provided. The document states: "Results of the design verification activities met the required acceptance criteria." and "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices." However, it does not list the specific acceptance criteria or the reported device performance metrics.

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

• Cannot be provided. The document refers to "design verification analysis" and "performance testing" but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.

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)

• Not applicable / Cannot be provided. This type of information is typically related to diagnostic or imaging device performance where expert review establishes ground truth. The CrossCLIP™ Implant System is a physical bone fixation device, and its performance testing would likely involve biomechanical or material properties testing, not expert interpretation of diagnostic data. The document does not mention any expert review process for establishing ground truth related to its performance studies.

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

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in diagnostic studies involving inter-reader variability. This document does not suggest such a method was used for the device's performance testing.

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 document describes a physical medical device (bone fixation implant), not an AI algorithm or a diagnostic aid. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Cannot be provided definitively. Based on the nature of the device (bone fixation implant), "ground truth" for performance testing would typically involve objective biomechanical measurements (e.g., pullout strength, compression force, fatigue life) compared against established standards (like ASTM F2063-12) or predicate device performance. However, the document does not explicitly state the type of ground truth used, only that performance was "verified against the predicate device" and "ASTM F2063-12 Standard Specification."

8. The sample size for the training set

• Not applicable. The device is a physical implant, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set for a machine learning model is involved.

Summary of available information from the document:

• Device Name: CrossCLIP™ Implant System
• Intended Use: Hand and foot bone fragment osteotomy fixation and joint arthrodesis.
• Regulatory Status: Substantially equivalent to predicate devices (K070031 and K124045).
• Performance Testing Mentioned: "Design verification analysis" and "Performance Testing" against predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
• Conclusion of Performance Testing: "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices."

To answer your request comprehensively, a detailed study report or technical documentation outlining the specific tests performed (e.g., mechanical testing protocols), their results, and the acceptance criteria used would be required, which is not present in this FDA 510(k) clearance letter.

Ask a specific question about this device

The Solana Surgical, LLC FuseForce Implant System is intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as: LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies

The Solana Surgical FuseForce Implant is a one-piece device made of Nickel Titanium Alloy intended to be implanted in the bones of the hand or foot. The implant is available in a range of sizes (12) ranging from 8 mm X 8 mm to 25 mm X 22 mm including both straight top and step top configurations. The design of the Solana Surgical implant is similar to the predicate device. No new materials or processes are used in the production of this implant. The device is provided in a sterile package which includes associated single use (disposable) instruments.

Acceptance Criteria and Study Details for Solana Surgical FuseForce Implant System

This document outlines the acceptance criteria for the Solana Surgical FuseForce Implant System and details the studies performed to demonstrate its compliance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FuseForce Implant System were based on its comparison to a legally marketed predicate device, the Memometal Memory Staples (K070031), and the Memometal EasyClip stable. The device was required to perform at least equivalently to the predicate in mechanical performance and corrosion resistance.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For both mechanical and corrosion testing, six subject devices and six predicate devices were evaluated for each test.
  • Mechanical Testing: 8mm x 8mm nitinol staples (worst-case for pullout, static, and fatigue bending).
  • Corrosion Testing: 25mm x 22mm nitinol staples (largest surface area, worst-case for corrosion susceptibility).
• Data Provenance: The data was generated through bench testing performed by Solana Surgical, LLC. The specific country of origin for the testing itself is not explicitly stated, but the company is based in Memphis, TN, USA. The data is prospective as it involves direct testing of the manufactured devices.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

• This device is a mechanical implant, and the ground truth for its performance is established through objective, standardized mechanical and material testing protocols (ASTM F564 and ASTM F2129).
• Therefore, the concept of "experts establishing ground truth" in the cognitive or interpretive sense, as seen in imaging studies, is not applicable here. The "ground truth" is defined by the objective measurements obtained from the testing.
• No human experts were used to establish ground truth in the context of interpretation or consensus for these purely mechanical and material property tests.

4. Adjudication Method

• Not applicable as the ground truth is established through objective, quantitative measurements from mechanical and material testing, not through expert interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging devices where human interpretation plays a role and the AI's impact on reader performance is being evaluated. The FuseForce Implant System is a mechanical implant, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The FuseForce Implant System is a physical medical device, specifically a bone fixation staple. It does not employ an AI algorithm, and therefore, a "standalone algorithm performance" study is irrelevant.

7. Type of Ground Truth Used

• The ground truth used was objective performance data derived from standardized mechanical and material property testing against established ASTM (American Society for Testing and Materials) standards:
  • ASTM F564 (for mechanical properties: pullout, static bending, fatigue bending)
  • ASTM F2129 (for corrosion resistance)

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI algorithm that requires a training set. The performance is based on the material properties and design of the manufactured product.

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

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared Easy Clip' devices (K070031).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Easy Clip" device:

It is important to note that the provided documents are a 510(k) Summary and an FDA clearance letter for a Class II medical device (Staple, Fixation, Bone). For this type of device, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device) through non-clinical testing, rather than performing a clinical trial with specific performance metrics like those for AI/Software as a Medical Device (SaMD).

Therefore, many of the requested categories related to clinical studies, expert-established ground truth, and AI-specific metrics (like MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

Note: For this type of device, "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) in the same way as for AI/SaMD. Instead, the acceptance criteria are implicitly that the modified device remains safe and effective, and performs comparably to the predicate device in relevant non-clinical tests. The "reported device performance" is the conclusion that these tests support substantial equivalence.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. For non-clinical testing of a medical device like a surgical staple, "sample size" refers to the number of physical units tested for mechanical properties. This specific number is not provided in the 510(k) summary.
   • Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical laboratory testing of the physical device.

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

   • Not Applicable. This submission relied on non-clinical engineering and material tests, not expert-established clinical ground truth. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM F2129) and the characteristics of the predicate device.

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

   • Not Applicable. No human adjudication of clinical cases was performed.

4. 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 is a physical medical device (staple), not an AI/SaMD product. No MRMC study was conducted.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission was based on established engineering and material standards (e.g., ASTM F2129 for corrosion) and the known performance and characteristics of the legally marketed predicate device (K070031). The goal was to demonstrate that modifications did not negatively impact these established benchmarks.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set was used.

Ask a specific question about this device