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For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.

The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.

The provided text describes the "Memory Staple™" device and a study performed to demonstrate its substantial equivalence to predicate devices, but it does not detail acceptance criteria in the typical sense of a diagnostic device or AI algorithm, nor does it present a study that proves the device meets specific performance thresholds in that context.

Instead, the document is a 510(k) summary, focusing on demonstrating substantial equivalence for a medical device. The "study" mentioned here is a mechanical test and a clinical observation that supports this claim, rather than a clinical trial designed to prove diagnostic performance against set criteria for an AI tool.

Therefore, many of the requested categories for AI/diagnostic studies (like MRMC, ground truth establishment, training set details) are not applicable to this submission.

Here's an attempt to answer based on the provided text, adapted to the context of a medical device submission demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable as an "AI/diagnostic acceptance criteria" table. The substantial equivalence argument for the Memory Staple relies on:

• Intended Use: Similar to predicate devices.
• Material: Nickel-Titanium shape memory alloy (similar to one predicate).
• Mechanical Strength: Demonstrated to be stronger than a predicate device.
• Clinical Use Observation: Successful in a reported series.

Since this is not an AI/diagnostic study, the following points are largely not applicable.

2. Sample size used for the test set and the data provenance

• Mechanical Test: "Prong separation tests were performed on the Memory Staple and the Landos Standard Staple." The sample size for these tests is not specified in the document.
• Clinical Observation: 315 osteotomies of the great toe.
• Data Provenance: The document does not specify the country of origin for the clinical observation data, but it refers to a report by "Barouk in 1994." It is retrospective, as it covers use between 1991-1994.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For the mechanical test, the "ground truth" is a measurement of force. For the clinical observation, "successful use" would likely be determined by the treating physician (Barouk). No panel of experts for ground truth establishment is mentioned.

4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned for the mechanical tests or the clinical observation.

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 an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.

7. The type of ground truth used

• Mechanical Test: Direct physical measurement (prong separation strength).
• Clinical Observation: Physician-reported "successful clinical use," which implicitly refers to positive patient outcomes in the context of the device's function.

8. The sample size for the training set
Not applicable. This is not an AI device and does not have a "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI device.

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Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the mid-foot, metatarsals and phalanges of the foot.

The 34mm SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 34mm in length. It is made of thanium alloy and is cannulated with a threaded head. This screw is an extension of the product line for the SCARF Thread-Head Screw.

This document is a 510(k) premarket notification for a medical device (34mm SCARF Thread-Head Screw), which focuses on establishing substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria, as these are typically part of a different type of submission (e.g., a De Novo submission or a PMA).

Here's why and what information is available:

• 510(k) Premarket Notification Purpose: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing design, materials, indications for use, and technological characteristics, rather than extensive new performance studies against predefined acceptance criteria.
• Missing Information: The provided text explicitly lacks the following information that would be necessary to answer the prompt:
  • A table of acceptance criteria and reported device performance.
  • Details of a study conducted to demonstrate performance against specific criteria.
  • Sample sizes, data provenance, expert qualifications, or adjudication methods for a performance study.
  • Information about MRMC or standalone performance studies.
  • Details about ground truth establishment or training sets.

What the document does implicitly convey about "acceptance":

The "acceptance" in a 510(k) context refers to the FDA's "substantial equivalence" determination. The letter from the FDA confirms:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
• "This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

In summary, based solely on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies because the document is a 510(k) summary focused on substantial equivalence, not a detailed performance study report.

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Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.

The Twist off Screw is made of titanium alloy and consists of a screw integrated with separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a selftapping tip.

This document describes the safety and effectiveness of the Medinov-AMP Twist-off™ Screw (K971069).

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" through specific threshold values or ranges. Instead, it reports the average performance values obtained from testing. The implication is that these reported values were deemed acceptable for market clearance.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided text, only "Testing of the Twist-off Screw was performed for the K962233." This indicates that tests were conducted, but the number of screw units tested is not specified.
• Data Provenance: Not specified. The manufacturer (Medinov-AMP) is located in Roanne, France, but the location where the testing was performed is not mentioned. The data is retrospective as the testing was completed prior to the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this device's performance relies on physical testing of mechanical properties (torque at rupture), not on expert opinion or interpretation of images/data.

4. Adjudication Method for Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving subjective interpretation (e.g., image reading by multiple experts). The testing performed here involved objective mechanical measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret images or data, and the device aims to assist or replace human performance. The Twist-off™ Screw is a physical implant, not a diagnostic or AI-driven device.

6. Standalone Performance Study

Yes, a standalone study was performed in the sense that the mechanical properties of the device (torque at rupture) were tested independently. The reported values (0.17 Nm and 0.37 Nm) are the standalone performance of the screw under specific test conditions. This is a direct measurement of the device's physical capabilities, not an algorithm's performance.

7. Type of Ground Truth Used

The ground truth used was physical mechanical measurement. Specifically, the torque required to induce rupture, both for the separation of the holder and for the screw itself, was directly measured during testing.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical implant, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a mechanical implant device.

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Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.

The SCARF Thread-Head Screw is a threaded bone fixation screw that is 3.0mm in diameter and 10 to 34mm in length (in 2mm increments). It is made of titanium alloy and is cannulated with a threaded head.

The provided text is a 510(k) premarket notification for a medical device called the SCARF Thread-Head Screw. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and device performance.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria and reported device performance
• Sample sizes for test sets or training sets
• Data provenance
• Number of experts or their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used or how it was established

The document primarily focuses on:

• Device Description: A threaded bone fixation screw, 3.0mm in diameter, 10-34mm in length, made of titanium alloy, cannulated with a threaded head.
• Intended Use/Indications: Fixation of fractures, fusion of a joint, or bone reconstruction of the mid-foot, metatarsals, and phalanges of the foot. (Note: The "Indications for Use" enclosure on Page 3 lists "phalanges, metacarpals and carpals of the hand," which appears to be a discrepancy or an initial proposed indication that was then changed or clarified in the main document. For this response, I'll use the main document's stated indications).
• Predicate Devices: Landos SCARF Thread-Head Screw, Zimmer Herbert-Whipple Bone Screw, and Osteomed M3 Screw.
• Regulatory Classification: Class II, product code 87HWC.
• Substantial Equivalence Determination: The FDA determined the device is substantially equivalent to predicate devices.

Summary of what can be extracted from the document:

The provided text describes a 510(k) submission for a medical device (SCARF Thread-Head Screw). In a 510(k) pathway, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to conduct studies that prove specific performance metrics against pre-defined acceptance criteria as would be typical for a novel high-risk device or an AI/software as a medical device (SaMD) study.

Therefore, the document does not contain a table of acceptance criteria and reported device performance because the submission method relies on demonstrating equivalence to existing devices rather than meeting new, explicit performance thresholds based on a study of the device itself.

The document does not contain the following requested information:

1. A table of acceptance criteria and the reported device performance: Not relevant for a 510(k) submission focused on substantial equivalence to predicate devices, where performance is implicitly similar to predicates.
2. Sample sized used for the test set and the data provenance: No test sets or associated data are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for a test set is described.
4. Adjudication method 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, as this is a physical implant device, not an AI or software device.
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.
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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This prosthesis is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The KAR Revision Hip is a non-cemented, long femoral stem made from Ti-6Al-4V, completely coated with hydroxyapatite. It has a straight stem with a quadrangular cross-section and blunt corners. The metaphyseal widening presents a bi-dimensional flare and horizontal and vertical grooves for metaphyseal support. The step-like structure of the grooves in the metaphyseal section provides stability. The distal section has symmetrical slopes. The diaphyseal section provides a distal anchor while the distal cross-slotted tip allows for elasticity in the stem and adaptability to the femoral curve. The stem has a 12/14 Morse-like taper.

Here's an analysis of the provided text regarding the KAR Revision Hip Prosthesis, focusing on acceptance criteria and the supporting study:

The provided documents describe a 510(k) submission for the KAR Revision Hip Prosthesis. A 510(k) submission typically aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria. Therefore, the information provided is structured around this regulatory pathway.

1. Table of Acceptance Criteria and Reported Device Performance

It's important to clarify that for a 510(k) submission, "acceptance criteria" for performance are usually framed as demonstrating comparable performance to a predicate device, rather than meeting specific numerical thresholds for a novel device. The "study" isn't a prospective pivotal clinical trial with a primary endpoint and corresponding statistical hypothesis and power calculation, but rather a comparison study.

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

The documents do not specify the exact sample size for the clinical studies. They generally refer to "Clinical studies."
The data provenance is not explicitly stated in terms of country of origin. However, given the manufacturer (Landanger-Landos, France) and sponsor (DePuy Orthopaedics, Inc., USA), it's possible the data could be from studies conducted in either or both regions, or other international locations.
The studies appear to be retrospective or a combination of retrospective and prospective observational studies, as there's no mention of a pre-planned, controlled clinical trial. The phrasing "Clinical studies indicate" suggests a review of existing clinical data.

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

The documents do not provide information on the number of experts, their qualifications, or how ground truth was established for the clinical data used in this 510(k) submission. This is not typically required to be detailed in this type of regulatory filing, as the focus is on substantial equivalence based on existing clinical outcomes data rather than de novo validation of a diagnostic algorithm.

4. Adjudication Method for the Test Set

The documents do not provide information on any adjudication method used for the clinical data.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images, not for orthopedic implants. The study described compares the performance of the implant itself.

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

This question is not applicable as the device is a physical orthopedic implant (a hip prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" here refers to the actual clinical outcomes of patients who received the hip prosthesis. This includes:

• Success Rate: Implies positive patient outcomes, likely measured through various clinical assessments over time.
• Post-operative Complications: Objective reporting of adverse events.
• Postel Merle D-Aubigne scores: A clinical scoring system used to assess hip function (pain, walking, mobility).
  The ground truth is essentially clinical outcomes data from patients.

8. The Sample Size for the Training Set

This question is not applicable. The KAR Revision Hip Prosthesis is a physical device, not an AI or algorithm that requires a "training set." The phrase "training set" refers to data used to train machine learning models.

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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The intended use for the 22.2/-4 Femoral Head is to complete the assembly of a Ti-6Al-4V semicanus and I he mended tise for the 22.27-4 rendral to the tapen of the Morphonetic Hip, manufactures by Medinov-AMP. The indications for use are artintis, arthrosis or any joint disease at the hip level, of wromans is, failed previous surgery or joint reconstruction.

The 22.2/44 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy.

This device is a physical medical device (femoral head) and not an AI/ML powered device, therefore most of the requested information is not applicable. I will provide the information that is available.

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

Not applicable. This is a physical device, and the testing described is mechanical, not based on data.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Not applicable. Ground truth for mechanical properties is typically established through direct measurement and testing, not expert consensus in the clinical sense.

4. Adjudication method 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. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used

The ground truth used for mechanical testing like burst load is typically derived from physical measurements and destructive testing of the devices themselves, adhering to established engineering standards for medical implants.

8. The sample size for the training set

Not applicable. This is a physical device, and "training set" is not relevant in this context.

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

Not applicable.

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The CORAIL® Total Hip Prosthesis is designed to restore hip mobility.

CORAIL® is a single-use, non-cemented, HA-coated prosthesis. The CORAIL® Total Hip Prosthesis is a complete set and consists of:

• femoral stem, made of titanium alloy and completely coated with hydroxyapatite, with a 12/14 morse taper; available with or without collar. It is grooved both vertically and horizontally to provide stability against driving in and rotation.
• Alumina or cobalt chrome femoral head
• acetabular cup, made of titanium alloy and coated with HA. Primary fixation is with two to five titanium screws, secondary fixation through HA.
• PE inserts available in flat-rim, anti-dislocation and reorientation.

This document is a 510(k) summary for the CORAIL® Total Hip Prosthesis. It does not contain the information required to answer your request in the specified format. Here's why:

1. Acceptance Criteria and Reported Device Performance Table: The document provides "success rates" (98% after 2 years, 97% after 5 years, 95% after 6 years) which could be interpreted as performance metrics, but it doesn't define formal "acceptance criteria" or present them in a comparable table as requested. This is a summary of clinical data, not a detailed study report.
2. Sample Size and Data Provenance (Test Set): The document states "over 38,000 implants... performed in Europe." This is a cumulative number of implants, not a specific sample size for a defined test set in a scientific study. The provenance is "Europe," and the data is retrospective ("Since its introduction in 1986").
3. Number and Qualifications of Experts (Test Set Ground Truth): This information is not provided. The data comes from general "success rates" in clinical practice, not a specific ground truth established by experts for a test set.
4. Adjudication Method (Test Set): This information is not provided.
5. MRMC Comparative Effectiveness Study: There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size for human readers with or without AI assistance. This device is a physical hip prosthesis, not an AI diagnostic tool.
6. Standalone Performance Study: There is no mention of a standalone performance study in the context of an algorithm's performance without human intervention. The "success rates" refer to the clinical performance of the device in patients.
7. Type of Ground Truth: The "ground truth" used appears to be clinical "success rates" over time from patient outcomes, reported by "Vidalain, J.P., MD, ARTRO Group - France." This is outcomes data, not expert consensus or pathology in the typical sense of a diagnostic device study.
8. Sample Size for Training Set: This device is a physical product, not an algorithm that requires a "training set" in the machine learning sense.
9. Ground Truth for Training Set: Not applicable, as it's not an AI/ML device.

In summary, this document is a regulatory submission for a medical device (hip prosthesis) and focuses on substantial equivalence and real-world clinical outcomes. It does not describe a study involving an AI/ML device with acceptance criteria, test sets, or ground truth establishment in the way your prompt is structured.

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The TWIST-OFF™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions.

The TWIST-OFF™ SCREW is a threaded Titanium bone fixation appliance intended to be implanted. It is composed of a self-tapping, selfcompressive screw and support as a single piece. These two components separate when the screw head comes in contact with the cortex. Screws come in lengths of 11,12,13 and 14 mm; the support does not vary in size.

This looks like a 510(k) premarket notification document for a medical device, specifically a bone fixation screw. These documents generally focus on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a more complex AI-driven diagnostic device would.

Based on the provided text, there isn't a comprehensive "study" in the sense of a clinical trial with acceptance criteria for device performance against human experts or a specific disease outcome. Instead, the "Summary of Studies" section describes bench testing to assess the mechanical properties of the device.

Here's an attempt to answer your questions based solely on the provided text:

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

2. Sample sized 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 "Rupture torque of the TWIST-OFF™ SCREW was compared..." without detailing how many screws were tested.
• Data Provenance: The standard referenced is "French Standard N° NF-F-90-414." This suggests the testing was conducted to a French standard, likely at the manufacturer's facility or a certified lab. It is a prospective bench test, not clinical data from patients.

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)

• Number of Experts: Not applicable. The "ground truth" here is a mechanical standard (resistance to torsion), not an expert interpretation of a clinical finding.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This was a mechanical test against a predefined standard.

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

• MRMC Study: No. This device is a bone fixation screw, not an AI-driven diagnostic tool that would involve human readers.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here relates to its mechanical integrity.

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

• Type of Ground Truth: The ground truth for the mechanical testing was an engineering standard (French Standard N° NF-F-90-414 for resistance to torsion).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device's demonstration of substantial equivalence. The device's design is based on engineering principles and comparison to predicate devices, not machine learning training.

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

• How Ground Truth for Training Set was Established: Not applicable. No training set was used.

Important Note: The information provided in 510(k) summaries is often limited to what is deemed necessary to demonstrate substantial equivalence. For a device like a bone screw, extensive clinical trials focused on efficacy might be unnecessary if its design and intended use are similar to already approved predicate devices, and its mechanical properties meet established standards.

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The SCARF THREAD-HEAD™ SCREW is intended to be implanted for fixation of bone fractures or bone reconstructions. The SCARF THREAD-HEAD™ SCREW is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

The SCARF THREAD-HEAD™ SCREW is a cannulated thread-head screw made of a Titanium alloy. Screws come in lengths of 10-32 mm in 2 mm increments.

This document describes a medical device, the SCARF THREAD-HEAD™ SCREW, and its intended use. It does not contain the information requested about acceptance criteria, device performance, studies involving AI, or ground truth establishment for a training set. The provided text is a summary of safety and effectiveness for a bone fixation screw and focuses on its description, intended use, and comparison to predicate devices, along with a single mechanical test.

Therefore, I cannot populate the table or answer the questions based on the provided text. The document is about a physical medical device, not an AI or software-based device that would typically have the kind of performance metrics and study details you've requested.

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The intended use for the 450mm it's is as a temporary ant to aid in the healing of lor fractures. I for children abo 110 130 ow 65 The 100mm Nancy Nail™ for small long bone with a long diaphysis. as carpal or tarsal bone

The I fancy Nail™ is a titanium alloy pin, available in two lengths: 450mm and 100mm The 450mm is available in five diameters: 2.0, 2.5, 3.0, 3.5, 4.0. The 100mm has a diameter of 1mm

The provided document does not contain information about acceptance criteria or a study that proves the device meets such criteria. It is a summary of safety and effectiveness for a medical device (Nancy Nail™ intramedullary elastic nail) under the K960642 submission. The document primarily focuses on:

• Manufacturer and Sponsor Identification: Contact details and registration numbers.
• Proprietary and Common Name: Nancy Nail™ (Intramedullary Elastic Nail).
• Classification: FDA classification as a Class II metallic bone fixation fastener (21 CFR Section 888.3040), specifically a flexible, metallic bone fixation pin.
• Intended Use: Temporary aid in healing long bone fractures for children (450mm nail for patients 110-130 lbs, under 65 inches; 100mm nail for small long bones like carpal or tarsal bones).
• Description: Titanium alloy pin available in two lengths (450mm and 100mm) and various diameters.
• Predicate Devices: Kirschner's Wire & Steinman Pin, Howmedica's Rush Nail.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text.

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