Search Results

• · Fixation of Metaphyseal Fractures of the Distal Tibia
• · Proximal Metaphyseal Tibial Fractures
• · Calcaneus Body Fractures
• · Proximal Humeral Head/Shaft Fractures
• · Distal Femur Fracture Comminuted Shaft Fractures
• · Fixation of soft tissue, such as tendon and ligaments, to bone

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

This document is a 510(k) summary for the DePuy ACE Spider Plate, seeking to expand its intended uses. It explicitly states that "The DePuy ACE Spider Plate has been previously cleared by the FDA for fracture fixation. Intended Uses are being expanded to include the fixation of soft tissue, such as tendon and ligaments, to bone."

The provided text does not contain information about specific acceptance criteria or a study proving the device meets them, especially not for the expanded indication. This document is a regulatory submission for substantial equivalence, not a clinical study report.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Acumed Suture Washer) for the expanded indication of soft tissue fixation.

The key statements supporting this are:

• "The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures."
• "The Acumed Suture Washer (K965028) is intended for soft tissue fixation, small and large bone fixation and is used in conjunction with a titanium bone screw."
• "The DePuy ACE Spider Plate and the Acumed Suture Washer are similar in design and function. Based on the above, DePuy ACE Medical Company considers the DePuy ACE Spider Plate to be substantially equivalent to the Acumed Suture Washer."

The FDA's response confirms substantial equivalence based on the submitted information for the expanded indications.

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• Pilon fractures distal tibial intra-articular fractures
• High medial malleolar fractures
• Low boot top type rotational distal extra-articular shaft fractures

The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia. The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).

The provided text describes a medical device, the DePuy ACE TiMAX™ Medial Pilon Plate, and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the DePuy ACE TiMAX™ Medial Pilon Plate is a "minor modification to the DePuy ACE TiMAX™ Pilon Plate and has been shown to have similar strength and bending properties." This suggests that a comparative analysis was performed to demonstrate "similar strength and bending properties" to an existing, cleared device, implying equivalence rather than performance against pre-defined acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not on a detailed performance study against specific acceptance metrics.

Here's what I can extract, which is that the device claims similar properties to a predicate device:

• Device: DePuy ACE TiMAX™ Medial Pilon Plate
• Predicate Device: DePuy ACE TiMAX™ Pilon Plate
• Claim of Equivalence: The new device "has been shown to have similar strength and bending properties" to the predicate.

To answer your request thoroughly, a different type of document (e.g., a detailed engineering report, a clinical trial summary, or a specific performance testing report) would be needed, which is not present in the provided 510(k) summary.

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• · Fixation of Metaphyseal Fractures of the Distal Tibia
• · Proximal Metaphyseal Tibial Fractures
• · Calcaneus Body Fractures
• · Proximal Humeral Head/Shaft Fractures
• · Distal Femur Fracture -- Comminuted Shaft Fractures

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

The provided text describes a 510(k) submission for a medical device called the "DePuy ACE Spider Plate." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the input does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to a predicate device (Acumed Suture Washer) based on similar design and function, rather than presenting a performance study against predefined acceptance criteria.

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• Distal intra-articular tibia fractures
• Proximal tibia fractures
• Proximal and distal humerus fractures

The DePuy ACE TiMAX™ Meta Plate has a triangular shaped projection at the end of a shaft portion. The shaft portion has compression slots with a pitch of 13mm which matches the small fragment, active compression plate. The plate thickness is 1.6mm in the shaft region and transitions to a thickness of 1mm in the triangular shaped metaphyseal region. A cut-out in the middle of the metaphyseal region provides an open architecture to facilitate contouring by the surgeon, to accommodate the anatomical topography of the distal tibia as well as other indicated anatomical regions, and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the 3.5mm cortical screw and the 4.0mm cancellous screw. The plate will be offered in two sizes: small (width=30mm) and large (width=38mm) with various lengths.

This document is a 510(k) summary for a medical device (DePuy ACE TiMAX™ Meta Plate), which focuses on establishing substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner an AI/software device would. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This document is for a traditional medical implant (bone plate), not a software or AI device. The "performance" assessment focuses on the physical and mechanical equivalence to an existing device, not on specific quantitative metrics or a study demonstrating achievement of pre-defined acceptance criteria in the context of an AI/software product. The acceptance criteria for this type of device generally relate to safety, material biocompatibility, mechanical strength (often through bench testing), and similarity in design and intended use to a predicate device. These are assessed through a broader regulatory review, not a single "performance study" as would be done for an AI algorithm.

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. There is no "test set" or "data provenance" in the context of an AI/software device for this submission. The "testing" for this bone plate would typically involve bench testing (mechanical and material properties) and potentially cadaver studies, but not a dataset in the way an AI algorithm uses it. The document does not provide details on sample sizes for these types of tests, if they were conducted.

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 in the context of an AI/software algorithm is described. For a bone plate, medical experts (e.g., orthopedic surgeons) would be involved in defining the intended use and potentially evaluating design, but not in establishing a "ground truth" for a dataset.

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

• Not Applicable. No "adjudication method" for a test set 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 not a study about human readers or AI assistance.

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

• Not Applicable. There is no algorithm discussed.

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

• Not Applicable. No "ground truth" in the context of an AI/software algorithm is described. The "ground truth" for a bone plate would be based on established medical and engineering principles, material science, and clinical experience with equivalent devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set."

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

• Not Applicable. There is no "training set" or ground truth establishment in this context.

Summary of what the document does provide in relation to regulatory acceptance:

• Predicate Device: The DePuy ACE TiMAX™ Meta Plate is deemed substantially equivalent to the Synthes Cloverleaf Plate (P/N 240.23), which was a pre-amendment device (marketed prior to May 28, 1976). This substantial equivalence is the primary "acceptance criterion" for 510(k) submissions.
• Intended Use: The device is intended for distal intra-articular tibia fractures, proximal tibia fractures, and proximal and distal humerus fractures. This must align with the predicate device's intended use or be demonstrably safe and effective for similar uses.
• Device Description: The document describes the plate's physical characteristics (triangular shaped projection, shaft with compression slots, plate thickness, cut-out for contouring, screw hole design compatible with 3.5mm cortical and 4.0mm cancellous screws, two sizes). These features are compared to the predicate device to establish equivalence.
• Regulatory Decision: The FDA determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This decision is the formal acceptance of the device for market.

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Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.

Here's an analysis of the provided text regarding the DePuy ACE Composite Locking Nut, focusing on acceptance criteria and supporting studies:

It appears the provided document is a 510(k) summary for a medical device (DePuy ACE Composite Locking Nut). This type of document is for demonstrating substantial equivalence to a previously cleared device, not typically for reporting detailed performance against acceptance criteria from a comprehensive clinical trial with human subjects. Therefore, much of the requested information (like MRMC studies, multi-reader performance, expert ground truth for imaging, and large training sets) is not applicable to this type of submission.

The "study" referenced is a mechanical performance test to demonstrate a specific physical characteristic of the new device compared to its predicate devices, rather than a clinical study of diagnostic accuracy or comparative effectiveness in humans.

Here's the breakdown of what can be extracted from the provided text according to your request categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text refers to "Testing," suggesting a certain number of units were tested to determine the ultimate and insertion torque values.
• Data Provenance: The study was conducted by DePuy ACE Medical Company. No specific country of origin for the data is mentioned beyond the company's location in El Segundo, CA, USA. This was a retrospective engineering test on manufactured devices, not derived from patient data.

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

• Not applicable. The ground truth for this engineering test was the direct measurement of torque values. It did not involve expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" here refers to the physical devices undergoing torque testing. There was no human interpretation or adjudication process involved in measuring a physical property.

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, an MRMC comparative effectiveness study was not done. This is a 510(k) for a mechanical device component, not an AI-powered diagnostic tool. The document does not mention any AI component or human reader studies.

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

• No. This is a mechanical device. There is no algorithm or standalone performance being evaluated.

7. The Type of Ground Truth Used

• The ground truth was direct objective measurement of physical properties: ultimate torque and insertion torque.

8. The Sample Size for the Training Set

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

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

• Not applicable. As there was no training set (see #8), no ground truth for a training set was established.

Summary of the "Study" (Test Report ET 63-001):

The only "study" mentioned in this 510(k) summary is "Test Report ET 63-001". This appears to be an internal engineering test conducted by DePuy ACE Medical Company.

• Purpose: To demonstrate that the DePuy ACE Composite Locking Nut allows for adequate fixation without accidental over-torque during application.
• Methodology: Measuring the ultimate torque (the torque at which the nut mechanically fails or rounds) and the insertion torque (the torque typically applied during surgical seating).
• Finding: The ultimate torque was found to be approximately 10 times that of the insertion torque.
• Conclusion: This 10x ratio is considered sufficient to allow surgeons to clearly identify when the nut is seated against the bone before accidental over-torque or rounding occurs. This finding directly supports the device's substantial equivalence and safe use.

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• Pilon fractures - distal tibial intra-articular fractures
• High medial malleolar fractures
• Low Boot top type rotational distal extra-articular shaft fractures

The DePuy ACE TiMAX™ Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft fractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with four screw holes and two k-wire guide holes for the distal metaphyseal region, and finally, an arm which wraps anteriorly to address the anterior crush fracture and facilitate articular surface reconstruction. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The shaft portion is thicker for strength. The plate is supplied pre-formed to a contour, which closely matches the distal tibia anatomy. The general contour includes a medial bend from the distal metaphyseal region combined with an internal rotation. The most distal profile includes the anterior arm with a large bend from the medial to the anterior surface with the bend apex located adjacent to the anterior strut. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate will be offered in a right and left model with various lengths of the shaft region. The DePuy ACE TiMAX™ Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).

This looks like a submission for a medical device (bone fixation plate) and not AI/ML software. The provided text describes the device, its intended use, and its substantial equivalence to a predicate device based on mechanical properties. It does not contain information about acceptance criteria, performance metrics, ground truth, or study details typically associated with AI/ML device evaluations. Therefore, I cannot extract the requested information from the provided text.

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The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:

• Intra-articular fractures of the calcaneus .
• Extra-articular fractures of the calcaneus .

The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is a fracture fixation plate intended for both intraarticular and extra-articular fractures of the calcaneus. The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and 12 anatomically relevant screw hole locations. The plate thickness is 1mm and provides a low profile fit to reduce peroneal tendon irritation. The open architecture of the plate allows easy contouring by the surgeon to accommodate the anatomical topography of the calcaneous and also to promote fracture healing. The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus. The screw holes are also contourable, designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate has countersinks on both sides to allow universal application of the plate; the same plate may be used on either the right or left side. The plate will be offered in two sizes: small and large. The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is manufactured from Titanium 6Al-4V ELI (per ASTM standard F136).

This document is a 510(k) summary for a bone fixation plate, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML device performance is not present in the provided text.

The document describes the DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate, which is a metallic bone fixation appliance used for treating intra-articular and extra-articular calcaneus fractures. The information provided focuses on the device's design, materials, intended use, and substantial equivalence to a predicate device (Synthes Calcaneal Plates K915818).

Here's why the specific questions about acceptance criteria for AI/ML and associated studies cannot be answered from this text:

• No AI/ML Component: The device described is a physical implant (a metal plate). There is no mention of any artificial intelligence, machine learning, software algorithm, or diagnostic function that would require specific performance metrics like sensitivity, specificity, AUC, or the need for ground truth established by experts.
• Regulatory Pathway: A 510(k) premarket notification for a traditional medical device like a bone plate primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparisons of:
  • Intended use
  • Design features
  • Materials
  • Performance characteristics (e.g., mechanical strength, biocompatibility – often demonstrated through bench testing or literature review, not clinical studies like those for AI/ML).
• Absence of Relevant Data: The document does not contain:
  • A table of acceptance criteria or reported device performance metrics relevant to an AI/ML system.
  • Information on test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for diagnostic performance.
  • Any discussion of multi-reader multi-case (MRMC) studies or standalone algorithm performance.
  • Details about training sets or how ground truth was established for "training."

In summary, the provided text describes a traditional medical device and its 510(k) clearance process, which is fundamentally different from the regulatory and testing requirements for an AI/ML-driven medical device.

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Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:

• Cervical fractures
• Ligamentous injury of the cervical spine
• Fusion or other surgery of the cervical spine

The skull pins, which pass through the halo ring or tong, are the only invasive component of the DePuy ACE cervical traction device. The new skull pins, ring and tong (fixed tip and spring loaded), now include a zirconia insert between the pin body and the pin tip. The zirconia insert eliminates the possibility of an electrical current passing to the patient which may cause a burning sensation at the pin insertion points.

The provided text is a 510(k) Summary for a medical device (DePuy ACE Skull Pins - MRI compatible) and the FDA's acceptance letter. It describes the device, its intended use, and argues for its substantial equivalence to previously approved devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device evaluations.

This is because the device described, "DePuy ACE Ring Skull Pin - MRI", is a physical medical device (pins, tongs, and halo rings for cervical spine stabilization), not an AI/ML-driven diagnostic or prognostic tool. For such physical devices, the "acceptance criteria" and "study" would typically refer to bench testing, material biocompatibility testing, mechanical strength testing, and potentially clinical performance studies comparing the new device's physical properties or patient outcomes to a predicate device. These types of studies are not detailed in this 510(k) summary; instead, the summary focuses on establishing substantial equivalence based on design similarity and intended use to pre-amendment devices or previously cleared devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence of a physical device, not on performance metrics of an AI/ML system.

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The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

The DePuy ACE A.I.M.® Titanium Tibial Nail is an intramedullary fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 11mm, 12mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE A.I.M.º Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5cm. The proximal end of the 10mm, 11mm, 12mm , and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nadiameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws and one 5mm long dynamization slot in the M-L plane. The distal end of the nail contains two 5.0mm holes in the M-L plane which accept 4.5mm solid cortical bone screws and one 5.0mm hole in the A-P plane positioned between the two transverse holes. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.

The DePuy ACE A.I.M. Titanium Tibial Nail is manufactured from Titanium 6A1-4V ELI (ASTM standard F-136).

The new DePuy ACE A.I.M.® Titanium Tibial Nail is the same basic design as the current DePuy ACE A.I.M. Titanium Tibial Nail, with the exceptions of adding a proximal dynamization slot in the M-L plane, which allows 5mm of length to dynamize across fracture site and that the two oblique proximal screw holes are moved more proximal to vield a longer working length for the nail. Also, there is an additional hole in the nail in the A-P plane. This is positioned between the current two distal transverse holes, allowing for oblique locking distally, which is more stable and allows the lagging of anterior fragments of the distal tibia. The additional holes and changes in placement are very similar to that of the Synthes Titanium Cannulated Tibial Nail and the Synthes Titanium Unreamed Tibial Nail.

The provided text describes a medical device, the DePuy ACE A.I.M.® Titanium Tibial Nail, which is an intramedullary rod for fixing tibial fractures. However, this document is a 510(k) summary and not a study report. Therefore, it does not explicitly define acceptance criteria or detail a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary regulatory pathway for this type of device. The "study" mentioned is a biomechanical testing study to compare the new device's strength to a predicate device.

Here's an analysis of the provided information in relation to your request, with the understanding that the nature of the document limits the direct answers to your specific questions about "acceptance criteria" for a cognitive task or "AI performance":

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics in the way one would define for a diagnostic or AI device (e.g., "sensitivity must be >X%", "AUC must be >Y%").
  • Implied Acceptance Criteria (for substantial equivalence): The new device must be "at least as strong or stronger" than the predicate device in biomechanical tests.
• Reported Device Performance:
  • "On all tests, the DePuy Tibial Nail was either at least as strong or stronger than the Synthes Tibial Nail."

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

• Sample Size for Test Set: Not specified. The document only mentions "Biomechanical testing was done." The number of different tests performed or the number of nails tested is not detailed.
• Data Provenance: Not specified. It's a biomechanical test, likely conducted in a lab environment rather than patient data.

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. This document describes a biomechanical test of physical strength, not a diagnostic or interpretive task that requires expert ground truth.

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

• Not applicable. This relates to expert consensus for ground truth, which is not relevant for a biomechanical strength test.

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. This is a biomechanical study, not a study involving human readers or AI.

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

• Not applicable. There is no algorithm or AI involved. The "device" is a physical implant. The "standalone performance" metaphorically refers to the intrinsic mechanical properties of the nail itself.

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

• Not explicitly stated in these terms. For biomechanical testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., yield strength, ultimate tensile strength, fatigue life) compared against established engineering standards or the performance of a predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a biomechanical test for substantial equivalence.

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

• Not applicable. As above, no training set. The "ground truth" for biomechanical properties is derived from established material science and engineering principles and testing methodologies.

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The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.

The DePuy ACE Trochanteric Side Plate is an optional component of the DePuy ACE Captured Hip Screw System (CHS). The new plate has a proximal extension with three holes placed in a triangular configuration. The proximal extension is designed for fixation of trochanteric fracture fragments. Hip fractures with comminution of the greater trochanter can be better controlled with use of the DePuy ACE Trochanteric Side Plate. By passing screws through the proximal flare, fixation of the greater trochanter and anti-rotation of the femoral head is controlled throughout the length of the plate. The DePuy ACE Trochanteric Side Plate is initially offered in 4, 6, and 8 hole configurations. The DePuy ACE Trochanteric Side Plate is manufactured from Ti-6A1-4V alloy.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:

Disclaimer: This 510(k) summary is for a medical device (bone fixation plate), not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML performance metrics, ground truth, and expert adjudication are not applicable or cannot be determined from the provided text. The responses below reflect this limitation.

Acceptance Criteria and Device Performance Study (K970503)

1. Table of Acceptance Criteria and Reported Device Performance

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. This 510(k) summary describes a traditional medical device (bone fixation plate), not an AI/ML-powered device. Therefore, there is no "test set" in the context of an AI algorithm being evaluated for performance on data. The evaluation relies on substantial equivalence to a predicate device, based on shared materials, indications, mechanical properties, and surgical techniques.

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. See point 2. No "ground truth" in the context of expert labels for data is established for this type of device submission. Device safety and efficacy are inferred through engineering analysis, material properties, and comparison to a legally marketed predicate.

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

• Not Applicable. See point 2.

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. This is not an AI/ML-powered device. A comparative effectiveness study with human readers assisting AI is irrelevant here.

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

• No. This is not an AI/ML-powered device.

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

• Not Applicable. For this type of device, the "ground truth" for substantial equivalence is implicitly the established safety and effectiveness of the predicate device, supported by engineering specifications, material standards, and clinical experience with similar devices. The evaluation here is based on physical and functional characteristics, not data labeling or clinical outcomes from a new study per se (in the context of a 510k).

8. The sample size for the training set

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

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