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The PERI-LOC™ Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC™ bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

The subject devices are design modifications to PERI-LOC™ Periarticular Locked Plating System devices previously cleared under K033669, K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates made from stainless steel. PERI-LOC™ locking bone plates incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text is a 510(k) summary for a medical device (PERI-LOC™ Locking Bone Plates). It describes design modifications to an existing device and asserts substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing performance.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided input.

Here's a breakdown of what can be inferred:

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

• Not available in the provided text. The document focuses on demonstrating substantial equivalence through design modifications, material composition, and intended use, rather than presenting new performance data against specific acceptance criteria.

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

• Not available in the provided text. No performance testing data is presented.

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 available in the provided text. No performance testing data is presented.

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

• Not available in the provided text. No performance testing data is presented.

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 / Not available in the provided text. This device is a mechanical bone plate system, not an AI-assisted diagnostic tool.

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

• Not applicable / Not available in the provided text. This device is a mechanical bone plate system, not an algorithm.

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

• Not available in the provided text. No performance testing data is presented. The "ground truth" for this type of device would typically involve mechanical testing (e.g., fatigue, static strength) and biocompatibility, but no such details are provided for this specific submission beyond asserting similarity to predicates.

8. The sample size for the training set

• Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set."

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

• Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set" or its associated ground truth establishment.

Summary of what the document does provide:

The document describes design modifications to existing PERI-LOC™ Periarticular Locked Plating System devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K033669, K051735, and K061352) based on:

• Identical indications for use.
• Identical material (stainless steel).
• Very similar technological design characteristics.

The modifications are described as minor (e.g., removal of tunnels, chamfers, tabs, or slots) and do not appear to fundamentally change the intended mechanical function or safety profile in a way that would necessitate new, extensive clinical or performance studies for this 510(k) submission. The FDA clearance letter confirms the substantial equivalence determination.

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The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Components in the PERI-LOC™ Periarticular Locked Plating System are for single use only.

Hexalobular Bone Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669, K051735, K061352, and K993106. Like the predicate devices listed below, the subject components include various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws made from stainless steel that are intended for use with locking bone plates for both the upper and lower extremity. The subject screws are designed for use with the PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming a locked, fixed angle construct to aid in holding fracture reduction.

This is a 510(k) premarket notification for a medical device called the PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws. These documents are generally used to demonstrate substantial equivalence to a predicate device, rather than to present a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new drug or novel medical software would.

Therefore, the requested information about acceptance criteria and a study proving those criteria are met for this type of device submission is largely not applicable in the conventional sense of a clinical performance study. Instead, the "study" is a comparison to a predicate device and a demonstration that the new device shares similar technological characteristics, materials, and intended use as the legally marketed predicate.

Here's a breakdown based on the provided document:

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

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are primarily established by the features and performance of the predicate devices. The new device must demonstrate that its technological characteristics (design, materials, intended use) are substantially equivalent to these predicates and do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that the PERI-LOC™ Hexalobular Bone Screws are "similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics." This inherent similarity to the existing, cleared predicate devices is the "reported performance" for a 510(k) submission. Specific quantitative performance metrics (e.g., tensile strength, fatigue life) would have been part of the full submission, but are not detailed in this summary. However, the summary asserts that these characteristics are comparable.

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

• Not applicable in the context of a typical clinical trial. This submission relies on a comparison to existing predicate devices and likely includes in vitro mechanical testing data (which is not detailed in this summary). There is no mention of a "test set" of patients or data provenance in the way one would for an AI/software or drug trial. The "test" is the comparison to the predicate device's established performance and characteristics.

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. There is no "test set" requiring expert ground truth in the context of clinical interpretation for this orthopedic implant. The "ground truth" for showing substantial equivalence for this type of device largely comes from engineering specifications, material standards, and the known clinical performance and regulatory history of the predicate devices.

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

• Not applicable. No such adjudication method is mentioned or relevant for this type of medical device submission.

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 submission is for an orthopedic implant (bone screws), not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

• Not applicable. This is not an algorithm or software device.

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

• For this device, the "ground truth" for demonstrating substantial equivalence includes:
  • Engineering specifications and material science: Demonstrating the new screws meet established standards for mechanical properties (e.g., strength, fatigue) comparable to the predicates.
  • Regulatory precedent: The predicate devices have already been deemed safe and effective by the FDA. The "ground truth" is that devices with similar characteristics have a history of safe and effective use.
  • Clinical experience with predicate devices: The established performance and safety profile of the predicate PERI-LOC systems.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning.

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

• Not applicable. As above, no training set for machine learning is involved.

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The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Components in the PERI-LOC™ Periarticular Locked Plating System are for single use only.

Volar Distal Radius Locking Plates for the Upper Extremity manufactured from ASTM F139 material are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text describes a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System – Volar Distal Radius Locking Plate for the Upper Extremity – ASTM F139 Material Change. This is a medical device submission, and the content focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating performance against specific acceptance criteria for a new AI or diagnostic algorithm.

Therefore, many of the requested categories for AI/diagnostic studies, such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.

The document primarily addresses the following aspects:

1. Device Description: It describes the Volar Distal Radius Locking Plates as line additions to an existing system, made from ASTM F139 material, and incorporating a screw-to-plate locking feature.
2. Intended Use: Specifies that the system is for adult patients with osteopenic bone and is indicated for fixation of various bone fractures.
3. Technological Characteristics: States that the device is similar to legally marketed devices in terms of indications, materials, and technological characteristics.
4. Substantial Equivalence Information: Compares the device to several predicate devices based on design features, indications, and material composition.

Key points from the document regarding the device's assessment:

• No specific acceptance criteria for a new performance metric are listed. The approval is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means the new device is considered as safe and effective as the predicate devices, without needing to prove new performance thresholds.
• No explicit study proving specific performance metrics is included. The 510(k) summary relies on comparison to predicate devices, implying that the established performance and safety of the predicates serve as the benchmark.
• No sample sizes for test sets, data provenance, expert numbers, adjudication, MRMC studies, or standalone performance are mentioned. These are typically associated with studies evaluating diagnostic or AI-driven devices, which this orthopedic implant is not.
• The "ground truth" for this type of device is implicitly the clinical performance and history of the predicate devices. Its substantial equivalence implies it should perform similarly in a clinical setting.
• No training set or ground truth establishment for a training set is relevant as this is not an AI/machine learning device.

In summary, based on the provided text, the device approval is based on substantial equivalence, not on meeting specific quantitative acceptance criteria through a performance study. The document does not contain the information required to populate the requested table or answer the specific questions about an AI/diagnostic study.

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PERI-LOC* Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC° contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC* VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

PERI-LOC™ Periarticular Locked Plating System - VLP Plates and Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K062216. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ VLP locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text is a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System. This type of submission is for medical devices and does not contain acceptance criteria or a study that evaluates the performance of an AI/ML powered device.

Instead, a 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device. This typically involves:

• Comparison of technological characteristics: Showing the new device has similar design features, materials, and technological properties to the predicate.
• Comparison of indications for use: Demonstrating that the new device is intended for the same population and conditions as the predicate.
• Performance testing (mechanical/biocompatibility): This usually involves non-clinical bench testing to ensure the device meets specified engineering and safety standards, but these are not the same as clinical studies evaluating AI model performance.

Therefore, I cannot extract the requested information from the provided text because it describes a traditional medical device (bone plates and screws), not an AI/ML powered device. The questions you've asked are relevant for AI/ML device submissions, which typically require different types of studies and acceptance criteria.

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PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal fibula, distal tibia, and proximal tibia. PERI-LOC Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, metacarpals, humerus, ulna, radius, calcaneus, and clavicle.

Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

PERI-LOC* Periarticular Locked Plating System - B-Plates are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC B-Plate locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text describes a 510(k) summary for the PERI-LOC® Periarticular Locked Plating System - B-Plate Locking Bone Plates and Locking/Non-locking Bone Screws. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm performance.

Therefore, the following information about acceptance criteria and studies is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the device itself. The focus is on demonstrating equivalence to existing devices.
• Sample size used for the test set and the data provenance: No test set is described, as the evaluation is based on comparison to predicate devices, not on a new performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 is a medical device for bone plating, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study generating "ground truth" data is described.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does state about the device's "study" and "criteria":

The "study" in this context is the 510(k) substantial equivalence submission process. The "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices.

The document explicitly states:

• Substantial Equivalence Information: "When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition."
• Predicate Devices:
  • PERI-LOC Periarticular Locked Plating System K033669
  • Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106

Essentially, the device "meets acceptance criteria" by being sufficiently similar in its technological characteristics, intended use, and materials to devices already cleared by the FDA, without requiring new clinical performance data.

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The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

The subject devices include PERI-LOC* Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws, which are line additions to and modifications to the PERI-LOC* Periarticular Locked Plating System devices previously cleared under K051735. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates, locking and non-locking bone screws made from stainless steel. PERI-LOC locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

This document is a 510(k) Summary of Safety and Effectiveness for the PERI-LOC® Locking Bone Plates and Locking and Non-locking Bone Screws for the Upper Extremity. It describes a medical device and its intended use, and states that it is substantially equivalent to previously cleared predicate devices.

Based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting novel performance data.

Therefore, I cannot provide the requested information in the format requested. The document does not contain:

1. A table of acceptance criteria and the reported device performance: This information is absent.
2. Sample size used for the test set and the data provenance: This information is absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is absent.
4. Adjudication method for the test set: This information is absent.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is absent.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: This information is absent.
7. The type of ground truth used: This information is absent.
8. The sample size for the training set: This information is absent.
9. How the ground truth for the training set was established: This information is absent.

The document primarily focuses on:

• Device Description: The PERI-LOC® Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity are line additions and modifications to a previously cleared system. They are made from stainless steel and incorporate a screw-to-plate locking feature.
• Intended Use: Fixation of pelvic, small, and long bone fractures in adult and pediatric patients, including those with osteopenic bone, across various anatomical sites.
• Technological Characteristics: Similar to legally marketed devices, with identical indications for use (compared to K051735), identical material, and very similar technological characteristics.
• Substantial Equivalence: Based on similarities with regard to overall indications for use, material composition, and technological design characteristics to predicate devices: Smith & Nephew Locked Plating System (K033669) and PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K051735).

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, subject to general controls provisions. This process for Class II medical devices like bone fixation appliances often relies on demonstrating equivalence to existing devices rather than requiring new clinical performance studies or specific acceptance criteria for novel performance metrics.

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