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The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or ostectomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

The Acu-Loc 2 Plate is a volar plate which is intended to provide fixation for distal radius fractures. The purpose of this Special 510(k) is to add 2.3mm Locking Variable Angle Screws for use with the Acu-Loc 2 Plate. All components are made of titanium alloy conforming to ASTM F136. This addition does not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a Special 510(k) submission for the Acumed Congruent Bone Plate System, specifically adding 2.3mm Locking Variable Angle Screws for use with the Acu-Loc 2 Plate.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text mentions "mechanical testing to characterize the screw/plate interface." However, it does not specify the sample size used for this mechanical testing.

• Test Set Sample Size: Not specified.
• Data Provenance: The testing was preclinical, implying it was conducted in a laboratory setting. The country of origin of the data is not specified, but the manufacturer is Acumed, LLC, located in Hillsboro, OR, USA, and the regulatory consultant is in Washington, DC, USA, suggesting the testing was likely conducted in the USA or by a facility adhering to US standards. The data is retrospective in the sense that the testing was completed before the 510(k) submission.

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

This information is not applicable as the study described is "preclinical testing" focusing on mechanical characteristics of a medical device (screws and plates), not a study involving human patients or interpretations by medical experts. The "ground truth" here would relate to the physical properties and performance of the device under specific mechanical loads, not a diagnostic outcome.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Mechanical testing results are typically evaluated against predefined engineering specifications, not through adjudication by experts.

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

This information is not applicable as the study described is preclinical mechanical testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.

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

This information is not applicable as the device is a physical bone plate system and screws, not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this preclinical mechanical testing would be the engineering specifications and performance metrics defined for the screw/plate interface (e.g., screw pull-out strength, torque limits, bending stiffness, fatigue life). These are established through recognized engineering standards and biomechanical principles, not typically by expert consensus in a medical diagnostic sense, pathology, or direct patient outcomes.

8. The Sample Size for the Training Set

This information is not applicable as the device is mechanical hardware, not an AI algorithm that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

The Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. Each of the plate styles utilizes the same screw types and screw instruments for insertion. All of the plates and screws are manufactured from titanium and are provided non-sterile. The screws were cleared for marketing and distribution under K942340 and K942341.

The provided text describes a 510(k) premarket notification for the Acumed Congruent Bone Plate System. This is a submission demonstrating equivalence to existing devices, not a study presenting novel performance data or acceptance criteria that would typically be associated with a new device development and validation.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not applicable to this type of regulatory submission.

Here's an explanation of what can be gleaned from the document in relation to your request:

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

• Not Applicable: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting new performance acceptance criteria through a specific study for a novel device. The "performance" is implicitly deemed acceptable if it is substantially equivalent to legally marketed predicate devices.

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: The submission does not describe a clinical or performance study with a test set of data. It relies on the established safety and effectiveness of predicate devices.

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: No ground truth establishment for a test set is mentioned.

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

• Not Applicable: No test set or adjudication method 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

• Not Applicable: This is a bone plate system, not an AI or imaging diagnostic device. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable: This is a medical device (bone plate), not an algorithm or AI system.

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

• Not Applicable: No ground truth is established for device performance in this document. The "ground truth" for regulatory approval in a 510(k) is the demonstrated safety and effectiveness of the identified predicate devices.

8. The sample size for the training set

• Not Applicable: There is no "training set" in the context of this 510(k) submission for a bone plate system.

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

• Not Applicable: As above, no training set or ground truth for a training set is relevant here.

Summary of Relevant Information from the Document:

While the document does not fit the typical structure for a performance study with detailed acceptance criteria, it does address the regulatory acceptance of a medical device based on substantial equivalence.

Device Description and Justification for Substantial Equivalence:

The Acumed Congruent Bone Plate System consists of bone plates and screws made from titanium, provided non-sterile. The plates are pre-bent. The screws were previously cleared under K942340 and K942341.

The justification for substantial equivalence is based on:

• Indication, Intended Use, Material, Design, and Size: The Acumed system is stated to be similar to several predicate devices.
• Predicate Devices:
  • Howmedica's Distal Humeral Plate (K890939)
  • Howmedica's Luhr Fixation System (K951415)
  • Synthes' Curved Reconstruction Plate (K913334)
  • Synthes' Modular Foot System (K001941)
  • Synthes' One-Third Tubular Curved Reconstitution Fibia Bone Plates (K912936)
  • Link's May Tibia Bone Plates

Acceptance Information (as interpreted for a 510(k) submission):

• Device Status: The device was determined to be "substantially equivalent" to legally marketed predicate devices.
• Performance Data (Limited): The document mentions that "On file at Acumed is data which shows that the instrumentation and implants can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 10-6." This is a specific performance aspect relating to sterility. However, no specific "acceptance criteria" (e.g., tensile strength, fatigue life thresholds) are explicitly stated in this public summary for the plates themselves, as these would typically be compared to predicate device performance or established standards during the engineering and testing phases, which are then summarized for the 510(k) reviewer.

In essence, the "acceptance criteria" for a 510(k) is whether the new device is as safe and effective as a legally marketed predicate device. The "study" proving this is the detailed comparison provided in the full 510(k) submission (not fully provided here, only the summary).

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