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OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instrumentations.

This document does not describe acceptance criteria or a study proving that the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for a medical device called the OSSIOfiber® Cannulated Trimmable Fixation Nail.

The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K203465), rather than proving performance against specific acceptance criteria through new clinical or non-clinical studies.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document explicitly states: "Non-clinical performance testing was not performed as the subject device does not represent a new mechanical performance worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail cleared family." This means the submission did not include new studies to generate performance data for this particular longer nail length against new acceptance criteria.
• Focus on Substantial Equivalence: The entire submission hinges on the claim that the new device (a longer version of an existing nail) has "the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K203465)." Because of this, new performance studies were deemed unnecessary by the manufacturer and accepted by the FDA for this specific 510(k) submission.
• No AI Component: The device described is a physical medical implant (a bone fixation nail), not an AI/ML-driven diagnostic or therapeutic device. Therefore, concepts like acceptance criteria for AI performance, training/test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not relevant to this submission.

In summary, the provided text does not contain the information required to answer your prompt because the 510(k) submission for this device did not involve new performance studies with acceptance criteria, as it was based on demonstrating substantial equivalence to a predicate device.

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restor3d Pin Implants are indicated for maintenance of alignment and fixation of bone fractures, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

restor3d pin implants are made from implant grade titanium alloy using an additive manufacturing process and possess a porous surface structure of unique topology. Pin implants are designed for use in a variety of surgical procedures including fixation of fractures, osteotomies, arthrodesis and as bone graft in the presence of additional immobilization. The pin implants are offered in a range of diameters, permitting surgeons to choose a relevant size for the affected anatomy.

The provided document is a 510(k) premarket notification for the "restor3d Pin Implants." This document pertains to a physical medical device (bone fixation pins) and describes its mechanical testing and comparison to predicate devices to demonstrate substantial equivalence for FDA clearance.

Therefore, the requested information regarding acceptance criteria and a study proving a software device meets those criteria is not applicable to this document. The document describes benchtop performance tests for a physical implant, not a software device or algorithm.

Specifically, the document states:

• "The proposed restor3d device was subject to the following benchtop performance tests to support the assertion of substantial equivalence: Bending Testing, Shear Testing, Pullout Testing."
• "No new questions of safety or effectiveness were identified during device testing; therefore, the restor3d Pin Implants are considered substantially equivalent to the predicate devices."

This indicates that mechanical performance criteria (bending, shear, pullout) were established and tested on the physical device to show it is comparable to existing devices, but these are not acceptance criteria for a software algorithm's performance.

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The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults. The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3). Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

This document is a 510(k) Summary for a medical device called the "Footmotion HammerToe." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML device, as this is a traditional medical device (an implant).

Here's an analysis based on the provided text, aligning with your request, but highlighting the differences for a non-AI/ML device:

1. Table of acceptance criteria and reported device performance:

Since this is an orthopedic implant, the "acceptance criteria" and "device performance" are not about AI model metrics like sensitivity or specificity. Instead, they refer to the physical and mechanical properties of the implant. The document states that the device is substantially equivalent to predicate devices based on:

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

• Sample size for test set: Not applicable in the context of an AI/ML model. The "tests" mentioned are biomechanical tests on the device itself, not clinical data.
• Data provenance: Not applicable for this type of device. The tests were performed on the physical implant. The manufacturer, NEWCLIP TECHNICS, is based in France.

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

• Not applicable. "Ground truth" in the context of this device refers to established engineering standards (ASTM, ISO) for material properties and performance. Biomechanical testing doesn't typically involve human experts establishing "ground truth" for the test results in the same way an AI model might. The "experts" would be engineers designing and conducting the tests according to established protocols.

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

• Not applicable. This concept applies to human review of data to establish ground truth, not to physical device 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:

• No. This is an orthopedic implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

• Not applicable. This is not an algorithm.

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

• For the non-clinical tests (flexion, pull-out), the "ground truth" is defined by established engineering standards and material specifications (ASTM F136-13 and ISO 5832-3 for the material) and the expected mechanical behavior for an implant of this type, as demonstrated by predicate devices. The tests aimed to show that the device meets these physical and mechanical performance expectations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary of the study/evidence for device acceptance:

The device's acceptance is based on a non-clinical study involving mechanical testing:

• Flexion tests
• Pull out tests

The purpose of these tests was to demonstrate the mechanical safety and performance of the Footmotion HammerToe range. The conclusion drawn is that the device is substantially equivalent to legally marketed predicate devices (Memometal Intra-medullary Bone Fastener, Pro-Toe Vo Hammertoe Implant System, Nextra Ti Hammertoe Correction System) based on:

• Similar principles of operation
• Similar technology
• Similar materials
• Similar indications for use

The submission explicitly states: "No clinical studies were performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

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The Bio2 Fusion Implant System is indicated for fracture fixation, osteotomies, and inter-digital fusion of the fingers, toes and small bones in the presence of appropriate immobilization.

When used in the foot (including hammertoe, claw toe, and mallet toe) patients should use protected weight bearing or heel bearing until fusion or healing has occurred.

The Bio2 Technologies Fusion Implant is a cylindrical shaped implant designed for fracture fixation repair, osteotomy and to fit into the proximal and distal sides of the proximal interphalangeal joints of the foot or hand. The implants are made of bioactive glass material that has been demonstrated to be biocompatible and osteoconductive. The implants are available in multiple diameters, lengths and in a straight and angled configuration. The implants are provided sterile and are intended for single use.

The provided text describes the Bio2 Fusion Implant System, a medical device intended for fracture fixation, osteotomies, and inter-digital fusion of fingers, toes, and small bones. The document is a 510(k) premarket notification from the FDA, aiming to demonstrate substantial equivalence to previously marketed predicate devices.

However, the document does not contain the kind of detailed information requested about the acceptance criteria and the study that proves the device meets those criteria, specifically for an AI/CADe device. The Bio2 Fusion Implant System is a physical implant, not a software or AI-based diagnostic tool.

Therefore, for this specific input, the following requested information cannot be provided as it is not present in the document:

1. A table of acceptance criteria and the reported device performance: Not applicable as this is a physical implant, and the performance testing described is mechanical, not related to AI metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for an AI test set. The document mentions "performance testing" of the implant but doesn't detail sample sizes or data provenance in the context of AI evaluation.
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 for a physical implant; ground truth establishment as it pertains to AI/diagnostic accuracy is not mentioned.
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, as this is not an AI-assisted diagnostic device.
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 for an AI device. The ground truth for biocompatibility and mechanical properties would be in vitro/in vivo assays and mechanical testing results.
8. The sample size for the training set: Not applicable, as there is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

Information that is available in the document regarding traditional device testing:

Performance Data Mentioned:
The document states: "Performance testing supports the substantial equivalence of the subject device to the predicate device."

• Biocompatibility: Established according to blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."
• In vitro bioactivity testing: (ISO 23317:2012) showed the material forms a surface apatite layer when submerged in simulated body fluid.
• Mechanical Testing: "Static and fatigue bending tests and in vitro stability tests were conducted on the subject and predicate devices to demonstrate substantial equivalence."

Type of Ground Truth Used (for a physical device):
For biocompatibility, the ground truth would be established through standard biological evaluation methods and outcomes per ISO-10993. For bioactivity, the formation of a surface apatite layer in simulated body fluid per ISO 23317:2012 is the ground truth. For mechanical performance, established engineering standards for static, fatigue, and stability tests serve as the ground truth.

Sample Sizes for these physical tests are not specified in this summary document.
Data Provenance (for physical device testing): Not specified beyond the tests being conducted on "the subject and predicate devices."

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