Search Results

The Speed™, Speed Shift™, Speed Titan™ and Speed ArcTM are indicated for:

• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy. ●
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Speed™ product family consists of nitinol staple implants offered in a range of sizes for bone fixation. The Speed™ product family consists of Speed™, Speed Shift™, Speed Arc™, and Speed Titan™ with the primary difference being the shape of the bridge. The bridges range from flat (Speed™ and Speed Titan™), arched (Speed Arc™), and stepped (Speed Shift™) to conform to patient and osteotomy anatomy.

All of the Speed™ implants are delivered to the operating room with the legs parallel in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient and body heat after insertion so that the legs converge. The implants do not require any external heating; they are completely transformed at typical operating room temperatures or body heat.

The difference between the Speed™ implant staples and the primary predicate implant staples are their heat activating temperature as well as bridge shape (stepped or curved). The predicate BME OSStaple™ requires an external heating unit to warm the staples and activate the compression function. The bundled implant staples are activated at typical operating room temperatures or body temperature, and provide active compression without an external heating requirement.

The provided document describes the safety and performance of "Speed™," "Speed Shift™," "Speed Titan™," and "Speed Arc™" bone staples through various bench tests, comparing them to predicate devices. It does not contain information about studies involving human readers or AI.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

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

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

The document does not provide specific sample sizes for the test sets in any of the performance bench tests. The data provenance is controlled laboratory testing, not medical data from patients.

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

Not applicable. These are bench tests on physical devices, not assessments requiring expert interpretation of medical data.

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or adjudication.

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 comparative effectiveness study was done. This document focuses on the physical performance of bone staples, not AI-assisted diagnosis or human reader performance.

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

This is not applicable, as the device is a physical bone staple, not an algorithm.

7. The type of ground truth used

The ground truth for these tests is based on the established material science and mechanical engineering standards (ASTM standards) that define the test methods and the expected performance for such medical devices. For example, "superior pull-out resistance" is a direct measurement against a standard and comparison to a predicate, not an expert opinion or pathology.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable.

Ask a specific question about this device

The Speed Shift™ is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed Shift™ is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is then transformed by ambient and body heat after insertion, and contracts to a "closed" austenitic state. The implants do not require any external heating; they are completely transformed by body heat. This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.

The provided documentation describes the Speed Shift™ device, a nitinol implant for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The submission focuses on demonstrating substantial equivalence to predicate devices (BME OSStaple™ and OSStaple™ Chill) through comparison of technological characteristics and performance bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of specific numerical thresholds for performance. Instead, the performance studies aim to demonstrate that the Speed Shift™ is equivalent or superior to the predicate devices in key mechanical properties. The acceptance is implicitly based on achieving this equivalence or superiority.

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

• Sample Size for Test Set: The document states that "Specimens of the largest and smallest sizes of the Speed Shift™ were used and compared to a comparably sized predicate OSStaple™" for pull-out and bending strength tests. For corrosion resistance, "representative samples of the new Speed Shift™" were compared to the predicate. The exact number of samples (n-value) for each test is not specified.
• Data Provenance: The studies are described as "Performance Bench Testing." This indicates the data was generated in a laboratory setting, likely in the US, by the manufacturer (BioMedical Enterprises, Inc.). It is retrospective in the sense that the device had already been designed and manufactured, and then tested for comparison. It is not clinical data from human subjects.

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

This question is not applicable to the provided information. The "ground truth" here refers to the actual mechanical properties, which are measured using well-established ASTM standards, not subjective expert assessment. No experts were used to establish ground truth for this type of bench testing.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation to resolve discrepancies between human readers or between human readers and an AI. In mechanical bench testing, the results are quantitative measurements, not subject to human adjudication in the same way.

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:

This question is not applicable. The Speed Shift™ is a physical medical implant (a bone staple), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this device.

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

This question is not applicable. As explained above, the Speed Shift™ is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these performance studies is physical measurement against established industry standards.

• For pull-out strength and bending strength: ASTM F564-10 (2010)
• For corrosion resistance: ASTM F2129-08

These standards define methods for objectively measuring the mechanical properties of bone fixation devices.

8. The Sample Size for the Training Set:

This question is not applicable. The Speed Shift™ is a manufactured device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The device undergoes design, manufacturing, and then testing.

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

This question is not applicable, as there is no "training set" for a physical medical device.

Ask a specific question about this device