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The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include:

• · Forefoot, Midfoot, and Hindfoot Osteotomies
• · Metatarsals and Metacarpals Corrections and Osteotomies
• · Stabilization and Fixation of Metatarsal and Metacarpal Fractures
• Stabilization and Fixation of Ankle Fractures
• Syndesmosis Joint Stabilization
• · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
• · Flatfoot and Cavus Foot Corrections
• Charcot Fixation

The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• · Posterior Malleolar Fractures
• · Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• · Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• · Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures

The ALPHALOK™ Plating System is a multi-indication solution providing polyaxial locking technology and low-profile plate designs. The ALPHALOK™ Ankle Fx plates and screws are intended to treat various fracture patterns of the ankle specifically tibia and fibula.

The intent of this submission is to expand indications to include ankle fractures, whereas the previous submissions for the ALPHALOK™ Plating Systems (K221558, K212348) were for forefoot and midfoot respectfully.

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

The provided text describes a 510(k) premarket notification for the ALPHALOK™ Plating System, which is a medical device for bone fixation. However, the document does not contain information about acceptance criteria, device performance in terms of clinical accuracy or statistical metrics, a study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies, as typically requested for AI/algorithm-based diagnostic devices.

The document is a regulatory submission for a physical medical device (bone plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and mechanical performance testing.

Therefore, I cannot provide the requested information from the given text alone.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not available. The document mentions "Static four point bend testing per ASTM F382-17" but does not provide specific acceptance criteria values (e.g., minimum load to failure, maximum deflection) or the reported performance data from these tests. These are engineering performance metrics, not clinical performance metrics typically associated with AI devices.
2. Sample sized used for the test set and the data provenance: Not available. The performance data mentioned (static bend testing) would involve physical specimens, not a "test set" of data in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device. Ground truth, in this context, would relate to an objective measurement of mechanical properties rather than expert interpretation of medical images or data.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for a physical bone fixation system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. For the mechanical testing, the "ground truth" would be the physically measured values from the tests.
8. The sample size for the training set: Not applicable. No AI model is described.
9. How the ground truth for the training set was established: Not applicable. No AI model is described.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone fixation system) and does not contain the type of information requested regarding acceptance criteria and studies for an AI/algorithm-based device.

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The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include:

• · Forefoot, Midfoot, and Hindfoot Osteotomies
• · Metatarsals and Metacarpals Corrections and Osteotomies
• · Stabilization and Fixation of Metatarsal and Metacarpal Fractures
• · Stabilization and Fixation of Ankle Fractures
• · Syndesmosis Joint Stabilization
• · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
• · Flatfoot and Cavus Foot Corrections
• · Charcot Fixation

The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx and ALPHALOK™ Recon, is a multi-indication reconstruction solution providing polyaxial locking technology and lowprofile design.

The ALPHALOK™ Met Fx contains various sizes of non-sterile straight plates, T plates, Y plates, Jones plates, mini plates, and locking and non-locking screws.

The ALPHALOK™ Recon contains various sizes of non-sterile fusion plates, Lapidus plates, peanut plates, straight plates, tab plates, T-plates, MTP plates, Cotton & Evans plates, utility plates, and Ankle Fracture plates along with locking and non-locking screws, and washers.

All implant components are manufactured from titanium (Ti-6A1-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

The provided text describes a medical device, the ALPHALOK™ Plating System, and its FDA 510(k) clearance. However, it does not contain any information regarding the acceptance criteria for an AI/ML medical device, nor does it describe a study proving such a device meets those criteria.

The document focuses on the substantial equivalence of the ALPHALOK™ Plating System to predicate devices, which is a regulatory pathway for traditional medical devices (bone plates, screws, and washers). The performance data mentioned (static four-point bend testing, torsional properties testing, axial pullout calculations, driving torque testing, engineering calculations, and cleaning/sterilization validations) are all entirely mechanical and material property tests relevant to the physical components of the plating system, not to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document is about a hardware medical device, not a software/AI one.

To answer your specific questions, the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not available, as it's a hardware device clearance, not an AI/ML performance study.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The performance data refers to mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would typically involve expert annotations of medical images or data. This document doesn't discuss AI or image analysis.
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.
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 to this type of device clearance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.

The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx Mini Plates, is a multi-indication reconstruction solution providing polyaxial locking technology and low profile design.

All implant components are manufactured from titanium (Ti-6Al-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

This K212348 FDA 510(k) summary provides information for the ALPHALOK™ Plating System, a bone fixation device. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details performance data provided in support of substantial equivalence. The acceptance criteria are implicitly met by demonstrating performance equivalent to the predicate devices through standardized testing. The "reported device performance" is that the device passed these tests, indicating it performs comparably to the predicate.

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

The document does not explicitly state the sample sizes used for each mechanical test. The tests are described as being performed "per ASTM F543-17" and "per ASTM F382-17," which implies that the sample sizes would adhere to the recommendations or requirements within those specific ASTM standards.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the performance of the ALPHALOK™ Plating System.

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

This section is not applicable as the studies are mechanical performance tests of a physical device (bone plates and screws), not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" here is the physical performance data measured according to established engineering standards.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reason as point 3. Mechanical performance tests typically do not involve human adjudication; the results are quantifiable measurements against established engineering benchmarks.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or imaging devices that rely on human interpretation, often assisted by AI. The ALPHALOK™ Plating System is a surgical implant.

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 device is a physical surgical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance studies of this device is based on standardized engineering specifications and measurements defined by the ASTM (American Society for Testing and Materials) and ANSI/AAMI/ISO standards. This includes:

• Mechanical properties: Measured values for torsional strength, axial pullout force, driving torque, and static four-point bend strength.
• Material properties: Chemical composition and physical properties of the titanium alloy, specified by ASTM F136.
• Cleaning and sterilization efficacy: Measured outcomes of cleaning and sterilization processes against predefined acceptance criteria for microbial reduction and residue levels.

8. The Sample Size for the Training Set:

This question is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

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

This question is not applicable for the same reason as point 8.

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