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The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

• · Arthrodesis in hand or foot surgery
• · Mono or bi-cortical osteotomies in the foot or hand
• · Fracture management in the foot or hand
• · Distal or proximal metatarsal or metacarpal osteotomies
• · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.

This document describes the 510(k) summary for the StealthFix Intraosseous Fixation System. It outlines the device, its intended use, and its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K220181). This typically means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical or performance data for a diagnostic device. The evaluation primarily relied on engineering analysis, materials comparison, and cadaveric testing.
• Data Provenance:
  • Engineering Analysis: Based on design comparisons and calculations.
  • Cadaveric Testing: Implied to be prospective testing carried out for usability evaluation.
  • Endotoxin Testing: Laboratory testing on device samples.

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

• Number of Experts: Not applicable in the context of this 510(k) summary, as it does not involve a diagnostic algorithm requiring expert-established ground truth on a test set. The assessment is based on physical and engineering properties, and direct comparison to a predicate device.
• Qualifications of Experts: Not specified or relevant for this type of submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The evaluation is not based on interpreting results from a test set that requires expert adjudication.

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: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

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

• Standalone Performance: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

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

• Type of Ground Truth: The "ground truth" in this context is established through:
  • Material Specifications: Conformance to ASTM standards for Ti-6Al-4V alloy and Stainless Steel.
  • Design Documentation: Verification of identical staple designs and comparison of screw designs to the predicate device.
  • Engineering Principles: Analysis demonstrating mechanical equivalence or non-inferiority of new screw designs.
  • Performance Standards: Meeting endotoxin limits.
  • Functional Assessment: Cadaveric testing for usability.
  • Predicate Device Performance: The safety and effectiveness of the predicate device (K220181) serves as the benchmark.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth Establishment for Training Set: Not applicable. This device does not involve a "training set."

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The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

• · Arthrodesis in hand or foot surgery
• · Mono or bi-cortical osteotomies in the foot or hand
• · Fracture management in the foot or hand
• · Distal or proximal metatarsal or metacarpal osteotomies
• · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), 3.5mm(small) and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and 20mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The system provides accessory instruments designed for preparation of the implant site and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile and non-sterile for single use. The instruments are provided non-sterile, reusable or non-sterile, single use and must be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "StealthFix Intraosseous Fixation System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/software device.

Therefore, many of the requested categories related to AI/software performance studies are not applicable to this type of regulatory submission. This document describes a traditional hardware medical device.

Here's the breakdown based on the provided information, with explanations for why certain sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide specific quantitative acceptance criteria or device performance metrics in the way an AI/software device would (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through material, design, and mechanical properties.

   Acceptance Criteria Category	Specific Criteria (Not explicitly stated as quantitative values for a software device)	Reported Device Performance
   Biocompatibility	Endotoxin limit ≤ 20 EU per device	Met the Endotoxin limit
   Mechanical Properties	Not creating a new worst-case for:	Engineering analysis performed; modified staples/screws do not create a new worst case for these tests.
   	- Static and dynamic 4-point bend testing (staples)
   	- Pullout force (staples) (ASTM F564)
   	- Torsional strength (screws) (ASTM F543)
   	- Pullout strength (screws) (ASTM F543)
   	- Insertion performance (screws) (ASTM F543)
   Substantial Equivalence	Equivalence in intended use, indications, material, design, sizes, mechanical properties to predicate device.	Achieved; differences do not raise new safety/effectiveness questions.

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a hardware device. The "tests" mentioned were engineering analyses and biocompatibility testing, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described for this hardware device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reason as above.

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 device is an orthopedic fixation system, not an AI/software diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance relies on engineering principles and biocompatibility standards, not clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set: Not applicable. No training set is involved for this hardware device.

9. How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.

Study Proving the Device Meets Acceptance Criteria (as described in this 510(k) submission):

The primary "study" that proves this device meets the regulatory acceptance criteria for 510(k) clearance is a demonstration of Substantial Equivalence to a legally marketed predicate device (K163440 - Stealth Staple System, First Ray LLC).

• Non-Clinical Testing:

  • Biocompatibility: Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161, and USP 85. The results met the endotoxin limit of ≤20 EU per device.
  • Mechanical Performance: An engineering analysis was conducted. This analysis ensured that modifications made to the subject device (increased internal thread length in staple posts, non-cannulated screws) did not create a new worst-case scenario for several mechanical tests that would typically be performed on such devices. These tests include:
    • Static and dynamic 4-point bend testing (for staples)
    • Pullout force (for staples, according to ASTM F564)
    • Torsional strength (for screws, according to ASTM F543)
    • Pullout strength (for screws, according to ASTM F543)
    • Insertion performance (for screws, according to ASTM F543)

• Clinical Testing: The submission explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device." This is a common aspect of 510(k) submissions where non-clinical data is deemed sufficient to establish equivalence.

• Conclusion: The submission concludes that "The StealthFix Intraosseous Fixation System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise different types of safety and effectiveness questions." This statement is the ultimate proof that the device, for the purposes of this FDA submission, "meets the acceptance criteria" of being substantially equivalent to a predicate.

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The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.

The Extremity Medical Intraosseous Fixation System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of the small bones and joints of the hand, wrist, foot, and ankle. The system consists of solid and cannulated screws, with the option of adding Washers; a standard/flat Washer, a Washer Post (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip for engaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths. Similarly, the lag screws come in varying diameters and lengths, and are also available in short and long thread configurations. The modified device is a product line extension and improvement to the Screw and Washer System, cleared under K121349, intended to provide modularity to the end user. New components to the system consist of cannulated 3.5 mm screws and implant accessories, X-Posts and X-Clips, to offer surgeons options for placement. Additionally, the system will offer additional thread length options for the 4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to those cleared under K121349.

This document, K201556, pertains to a 510(k) premarket notification for a medical device called the "Intraosseous Fixation System," manufactured by Extremity Medical, LLC. It is a Class II device (21 CFR 888.3040) classified as a smooth or threaded metallic bone fixation fastener.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or an AI/ML algorithm. The document describes a traditional medical device (implants for bone fixation) and its substantial equivalence to predicate devices based on design, materials, and mechanical properties. There is no mention of an AI/ML component, image analysis, or any performance metrics typically associated with such systems.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, test set details, ground truth establishment, or human reader studies related to an AI/ML device, as none of that information is present in the provided FDA 510(k) clearance document.

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The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction. Furthermore, the surgeon may optionally elect to use suture that passes through the distal end of the implant for closure.

The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.

The design features of the CrossTie™ Intraosseous Fixation System are summarized below:

• O Implant Grade PEEK
• O Sized to accommodate patient anatomy
• Solid, one piece construction for all devices O
• Proximal and distal barb-like features for secure placement O
• Hole to optionally aid in joint reduction O

Here's a breakdown of the acceptance criteria and study information based on the provided text for the CrossTie™ Intraosseous Fixation System:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not contain a specific table or detailed quantitative acceptance criteria for this specific submission (K151270). However, it states that "All analyses were verified to meet the required acceptance criteria." and "Evaluation of the system with and without utilizing the suture for closure demonstrates that the subject device is substantially equivalent in static and fatigue performance compared to the predicate device."

Since K151270 is an update to a previously cleared device (K141857) with only a minor change (surgical technique for suture use), the performance focus is on demonstrating equivalence to the predicate. The performance testing section mentions "static and fatigue performance" as key areas.

Based on the text, the implicit acceptance criteria would be equivalence in static and fatigue performance to the predicate device (K141857).

Important Note: The document does not provide the specific quantitative thresholds or numerical results for static or fatigue performance, only the conclusion of substantial equivalence.

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

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is likely bench testing (in vitro) rather than human or animal studies, given the nature of the device (fixation system) and the mention of "cyclic tested."

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

This information is not applicable as the described performance testing (static and fatigue) would involve engineering analysis and physical testing, not expert interpretation of outputs to establish ground truth in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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

An MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic AI devices where human readers interpret medical images. The CrossTie™ Intraosseous Fixation System is a surgical implant, and its evaluation focuses on mechanical performance.

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

This information is not applicable. The device is a physical intraosseous fixation system, not an algorithm. Performance testing would be of the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on engineering principles and mechanical testing standards. The performance attributes (static and fatigue strength) are measured empirically through physical tests, not through expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The CrossTie™ Intraosseous Fixation System is a physical medical device, not an AI or machine learning model that requires a "training set."

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

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

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The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction.

The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.

The design features of the CrossTie™ Intraosseous Fixation System are summarized below:

• Implant Grade PEEK o
• Sized to accommodate patient anatomy O
• O Solid, one piece construction for all devices
• Proximal and distal barb-like features for secure placement o
• Hole to optionally aid in joint reduction O

The provided text is a 510(k) premarket notification for a medical device called the "CrossTie™ Intraosseous Fixation System". This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way a clinical trial or a performance study for a novel AI/software medical device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this regulatory submission context. This document primarily relies on design verification analysis and material/dimensional evaluation to show equivalence to existing devices.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format with corresponding reported performance for specific metrics. Instead, it relies on demonstrating that "All analyses were verified to meet the required acceptance criteria" and that the device has "substantially equivalent rigidity to the predicate devices" based on "design verification analysis" and "evaluation of the material and dimensions."

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

• Sample Size (Test Set): Not applicable for the type of testing described. The document refers to "design verification analysis" and "cyclic tested," which typically involve a limited number of device samples in a laboratory setting, not a "test set" in the context of clinical data or AI validation.
• Data Provenance: Not applicable. The testing described is in-vitro mechanical testing.

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

• Not applicable. This information is for clinical or diagnostic AI/software studies, not for the mechanical testing described here.

4. Adjudication method for the test set

• Not applicable. This information is for clinical or diagnostic AI/software studies, not for the mechanical testing described here.

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. A MRMC study was not done. This device is a surgical implant, not an AI or imaging diagnostic tool.

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

• Not applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

• Mechanical Engineering Principles / Industry Standards: The "ground truth" for this device's performance is based on established mechanical engineering principles, material science, and potentially relevant ASTM or ISO standards for medical implants. The goal is to demonstrate that the device's mechanical properties (e.g., strength, rigidity, fatigue resistance) are suitable for its intended use and equivalent to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This information is for AI/machine learning models. The document describes a physical medical device.

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

• Not applicable. This information is for AI/machine learning models. The document describes a physical medical device.

Summary of Key Information from the Document:

• Device: CrossTie™ Intraosseous Fixation System
• Purpose of Submission: New Device 510(k) for substantial equivalence to predicate devices.
• Intended Use: Aid in the fixation of fractures, fusions, and osteotomies of the toes (e.g., hammertoe, claw toe, mallet toe, interdigital fusions).
• Predicate Devices: K133636 – HammerFix IP Fusion System, K113006 – PhaLinx Hammer Toe System, K120165 - CannuLink Instraosseous Fixation System, K073674 – Kirchner Wires.
• Performance Testing Mentioned:
  • Design verification analysis performed to meet acceptance criteria derived from risk analysis and product requirements.
  • Evaluation of material and dimensions to demonstrate substantially equivalent rigidity to predicate devices.
  • Cyclic testing to demonstrate the device can withstand expected loads.
• Conclusion: The manufacturer asserts that "minor differences between the subject and predicate devices...are insignificant in the safety and efficacy of the devices" and that the subject device "is substantially equivalent to the predicate devices."

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The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy or PEEK.

This document is a 510(k) premarket notification summary for the "Intraosseous Fixation System" by Tornier, OrthoHelix Surgical Designs, Inc. It details the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not describe an acceptance criteria table, a study proving device performance against such criteria, or any of the other specific items requested in your prompt (sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details).

This type of submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often relying on mechanical testing to show similar performance characteristics to the predicate, rather than clinical efficacy studies with specific acceptance criteria as you've outlined.

Therefore, I cannot extract the requested information from the provided text. The document does not contain the details for:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical testing (4-point bend, axial pull-out, insertion/removal torque, torque to failure) to establish substantial equivalence, but it doesn't present these as "acceptance criteria" for a specific study, nor does it provide the exact performance values against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with ground truth establishment 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 medical device, not an AI or imaging diagnostic tool.
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: 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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The Intraosseous Fixation System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy.

The provided text is related to a 510(k) summary for the OrthoHelix Surgical Designs, Inc. Intraosseous Fixation System. This document outlines the device description, intended use, and substantial equivalence to predicate devices based on mechanical testing. It does not describe a study involving a comparison of device performance against acceptance criteria using statistical measures on a test set, nor does it refer to human readers, experts, or ground truth as would be relevant for a medical imaging or diagnostic device.

Therefore, many of the requested categories of information are not applicable to this submission.

Here is the information that can be extracted from the provided text based on your prompt:

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

Regarding the other points, the provided text does not contain the information needed to answer them as they pertain to studies typically performed on diagnostic or AI-enabled devices.

• 2. Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing, not a diagnostic accuracy study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for this type of mechanical testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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 or diagnostic 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. No training set was involved in this type of mechanical testing.
• 9. How the ground truth for the training set was established: Not applicable.

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