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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:

• · Hammer toe deformity
• · Claw toe deformity
• Mallet toe deformity
• Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.

This document is a 510(k) premarket notification for the Integra® DigiFuse® Cannulated Intramedullary Fusion System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a separate, extensive study to define new acceptance criteria and prove performance against them.

Therefore, the requested information regarding acceptance criteria, device performance from a specific study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not typically present or required in this type of submission.

Instead, the submission relies on demonstrating substantial equivalence to existing devices, meaning it performs as safely and effectively as a legally marketed device that does not require premarket approval (PMA).

Here's an analysis based on the provided document:

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

This document does not present a table of specific acceptance criteria (e.g., specific clinical outcomes, sensitivity/specificity thresholds) and reported device performance against those criteria. The acceptance is based on demonstrating substantial equivalence to predicate devices, not on meeting new quantitative performance metrics from a distinct study.

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

• No specific "test set" and corresponding sample size for clinical or AI performance evaluation are mentioned.
• The document states "Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence." This refers to engineering and material testing, not a clinical trial or performance study on a "test set" of patient data in the context of AI or diagnostic performance.

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

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance.

4. Adjudication method for the test set:

• Not applicable. No such test set or adjudication is described.

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 study or AI assistance is mentioned. This device is a physical implant (Cannulated Intramedullary Fusion System), not a software or AI-powered diagnostic tool.

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

• Not applicable. This is a medical device, not an algorithm, so standalone AI performance is irrelevant.

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

• For a traditional 510(k) submission like this, the "ground truth" for the device's equivalence isn't clinical outcomes from a new study, but rather the established safety and effectiveness of the identified predicate devices. The "proof" is in demonstrating that the new device shares fundamental technological characteristics and has similar intended use, materials, and design principles to the predicates without raising new questions of safety or effectiveness. "Non-clinical evaluation and dimensional analysis" would be used to ensure the physical properties meet engineering standards applicable to the predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI or machine learning for this physical implant device.

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

• Not applicable. As there is no training set mentioned, this question is not relevant.

Summary of what the document does provide regarding equivalence:

• Predicate Devices:
  • Metasurg DigiFuse Implant – K111536
  • OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863
  • NewDeal K-Wire – K022599
• Basis for Equivalence:
  • The Integra® DigiFuse® Implant is made of the same material (Titanium Alloy (Ti 6A1-4V ELI)) as the Metasurg predicate device (K111536).
  • The only difference with the Metasurg predicate is the addition of two new lengths for the Integra® DigiFuse® implant.
  • These two new lengths are already within the length range of the Osteomed predicate device (K062863).
  • The submission explicitly states: "There are no design, material, or indication differences between the proposed device and predicate devices." (This is crucial for 510(k) acceptance).
  • Substantial equivalence was confirmed through "Non-clinical evaluation and dimensional analysis." This refers to engineering tests to ensure physical and mechanical properties are comparable to the predicates, not a clinical trial on patient-specific data.

In essence, the "acceptance criteria" for this specific 510(k) clearance are derived from the characteristics and performance of the legally marketed predicate devices. The study proving this "acceptance" is the non-clinical evaluation and dimensional analysis demonstrating that the Integra® DigiFuse® device is fundamentally the same as or comparable to its predicate devices, especially regarding materials, design, and intended use, and that any minor differences (like additional lengths) do not introduce new safety or effectiveness concerns.

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