Search Results

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.

Ask a specific question about this device

The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 4 diameter sizes of 2.0mm, 2.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.

The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.

The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The provided text describes the regulatory clearance for the "OSTEOMED ExtremiFuse System" and does not contain information about an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence, which is a different type of evaluation from an AI/ML model.

Here's the information based on the document:

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

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

The document does not specify a "sample size" for a traditional clinical "test set" in the context of an AI/ML device. Instead, it refers to mechanical testing.

• Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "The ExtremiFuse implants underwent verification..." and references "pullout test, and bending test." It does not provide the number of implants tested.
• Data Provenance: Not applicable in the context of clinical data. This refers to mechanical performance testing of the device itself.

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. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images or diagnoses) was not established for this type of device submission. The "ground truth" here is adherence to mechanical performance standards and achieving substantial equivalence to predicate devices.

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

Not applicable. There was no clinical assessment requiring adjudication by multiple experts. The evaluation was based on mechanical testing and comparison to predicate devices.

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. An MRMC comparative effectiveness study is designed for AI/ML devices involving human readers. This submission is for a physical orthopedic implant and does not involve AI/ML or human readers in that capacity.

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

Not applicable. This device is not an algorithm or AI system. It is a physical implant.

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

The "ground truth" for this device's evaluation was based on:

• Mechanical performance standards: The device's physical properties (e.g., strength, durability in pullout and bending tests) were verified against established criteria for its intended use.
• Comparison to predicate devices: The device's design, materials, function, and performance were compared to already legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. No AI/ML model was trained.

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

Not applicable. No AI/ML model was trained.

Ask a specific question about this device

OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist Plating System implants are intended for single use only.

The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.

Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided text describes a 510(k) summary for the OsteoMed Wrist Plating System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting a de novo clinical study with specific acceptance criteria, sample sizes, and ground truth establishment for novel device performance.

Therefore, the requested information regarding acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set is not applicable or available within this 510(k) submission.

The document states:

• "Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices." This implies mechanical bench testing for equivalence, not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
• "Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues." This is the core argument for a 510(k) submission.

Without a clinical study explicitly designed to measure performance against predefined acceptance criteria, it's impossible to populate the requested table and answer many of the questions.

Ask a specific question about this device