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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 predicate Congruent Bone Plate System (K012655) consists of bone plates and screws which provide fixation for fractures, fusions, and osteotomies of the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula. The purpose of this 510(k) is to modify two components of the Congruent Bone Plate System and to add one component to this predicate system. These modifications are intended to allow the operating surgeon to better accommodate various patient anatomies when treating distal and midshaft fractures of the radius. All components are made of titanium alloy conforming to ASTM F136.

The provided text describes a 510(k) summary for the Acumed Congruent Bone Plate System. This is a medical device for bone fixation, and the summary details its indications for use, device description, and preclinical testing.

However, the information required to answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text. The document refers to preclinical testing (static and dynamic 4-point bend testing in accordance with ASTM F382) to demonstrate substantial equivalence to a predicate device. This type of testing evaluates the mechanical properties of the device, not its "performance" in the context of diagnostic accuracy, human reader improvement, or ground truth establishment, which are typical metrics for AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions related to sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these concepts are not applicable to the type of device and testing described in this 510(k) summary.

In summary, the provided document does not contain the requested information regarding acceptance criteria and studies related to diagnostic/AI performance.

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

The Acumed 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. All plates and screws are manufactured from Titanium in conformance with ASTM F136, Stainless Steel in conformance with ASTM F138 and ASTM F2229, and Cobalt Alloy in conformance with ASTM F90. Plates and screws are provided non-sterile.

The provided text is a 510(k) summary for the Acumed Congruent Bone Plate System. This document is for a medical device (bone plates and screws) and emphasizes its substantial equivalence to previously marketed devices. It does not contain any information about acceptance criteria or a study proving device performance in the way you've described (e.g., diagnostic accuracy metrics, clinical trial results).

Here's why the requested information cannot be extracted from this document:

• Type of Device: The Acumed Congruent Bone Plate System is a hardware device (bone plates and screws) used for fixation. Its safety and effectiveness are established primarily through material conformance, mechanical testing (which is alluded to by "performance data is not applicable" in the context of clinical studies, but certainly performed for mechanical properties), and comparison to predicate devices, not through studies evaluating diagnostic accuracy or algorithmic performance.
• "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.": This specific statement in the 510(k) summary indicates that the submission relies on substantial equivalence to predicate devices and does not include new clinical or non-clinical performance studies (like a diagnostic accuracy study you're asking about) to demonstrate safety and effectiveness. This is common for many Class II hardware devices.

Therefore, I cannot fill in your requested table and study details. If this were a submission for an AI/ML-driven diagnostic device, that information would be critical and usually included.

Based on the provided document, I must state that the information requested regarding acceptance criteria and a study proving the device meets those criteria (in the context of diagnostic performance) is not available.

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

The Acumed Scapula 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. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.

The Acumed Congruent Bone Plate System is a medical device and the provided 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The device obtained substantial equivalence based on its technological characteristics and intended use being similar to legally marketed predicate devices, not on specific performance data or a study demonstrating meeting acceptance criteria.

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The Acumed Scapula Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the scapula.

The Acumed Scapula 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. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136. Plates and screws are provided non-sterile.

This submission, K051083, is for the Acumed Scapula Congruent Bone Plate System. This device is a metallic bone fixation appliance.

Here's an analysis 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 document states, "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that no dedicated test set or study was performed to prove the device meets acceptance criteria. The claim of safety and effectiveness relies on substantial equivalence to predicate devices. Therefore, there is no sample size and no data provenance in the traditional sense of a study.

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

Since no test set or study was conducted, no experts were used to establish ground truth for this device in isolation. The evaluation relies on the known safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

As no test set was used, there was no adjudication method employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed. The document explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." Therefore, there is no effect size of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study was done as this is a physical medical device (bone plate system), not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth implicitly used for this submission is the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed "substantially equivalent" based on its characteristics (materials, intended use) aligning with those predicates.

8. Sample Size for the Training Set

No training set was used for this type of device submission. The submission relies on demonstrating substantial equivalence to existing devices, not on training a model.

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

Since no training set was used, there was no ground truth established for a training set. The basis for approval is the comparison to predicate devices, which have already been established as safe and effective through their own regulatory processes (which would have involved various forms of testing and clinical data).

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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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