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The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.

The Pitch -Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile, by Gamma Irradiation to an SAL of 10-6.

The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.

The provided text describes a medical device called the "Pitch-Patch Tissue Reinforcement Device" and its FDA 510(k) clearance application. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical surgical mesh device, not an AI software or system. Therefore, details like AI performance metrics (sensitivity, specificity, AUC), test set characteristics, expert ground truth establishment, MRMC studies, or training set details are not applicable to the information given.

The "Performance Data" section lists various mechanical and biological tests for the Pitch-Patch (e.g., Suture Retention, Ultimate Strength, Biocompatibility). These are typical for surgical mesh devices to demonstrate safety and effectiveness for their intended physical function, but they are not the type of acceptance criteria or studies relevant to AI/ML device performance.

Therefore, I cannot provide the requested information for an AI/ML device based on the input text.

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The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (Poly-Tape/Infinity-Lock) is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. The Poly-Tape/Infinity-Lock is a permanent implantable device for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a non-resorbable surgical mesh intended for reinforcing soft tissues during tendon and ligament repair surgery. The provided text outlines the device's characteristics and references performance testing, but does not specify numerical acceptance criteria or provide detailed results from a formal study proving the device meets those criteria.

Here's an analysis based on the provided input, highlighting what's available and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The series of tests, listed above, has been conducted and successfully completed," but it lacks the quantitative acceptance criteria (e.g., minimum tensile strength of X Newtons, maximum elongation of Y %, etc.) and the actual measured performance values that would typically be found in a detailed study report.

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

The document lists types of performance testing conducted (Suture Retention, Ultimate Strength, Cyclic, Packaging, Biocompatibility), but does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not applicable as the device is a physical implant and the testing described is mechanical and biological in nature, not an AI/diagnostic device that requires expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 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

This information is not applicable as the device is a physical implant and not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical implant and not an algorithm.

7. The type of ground truth used

For the mechanical properties (Suture Retention, Ultimate Strength, Cyclic Testing), the "ground truth" would be established by physical measurement standards and engineering principles (e.g., ASTM or ISO standards for material testing).

For biocompatibility, the "ground truth" is established by validated biological tests as defined by ISO 10993 series.

For packaging integrity, the "ground truth" is established by validated packaging test methods (e.g., ASTM standards).

For endotoxin levels, the "ground truth" is established by pharmacopeial methods like the LAL test.

The document states these tests were "successfully completed," implying adherence to established regulatory and scientific standards for "ground truth."

8. The sample size for the training set

This information is not applicable as the device is a physical implant and does not involve a training set as would be used for AI/machine learning.

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

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

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The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons .

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the bone, provide mechanical strength for the repair.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. These devices are permanent implants for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, and discusses its substantial equivalence to other predicate devices for FDA clearance.

It details:

• Acceptance criteria: Not explicitly stated in terms of clinical performance metrics, but the document implies that "adequate mechanical properties for its use in soft tissue reinforcement" are criteria demonstrated through various tests.
• Device performance: The text states that "The results demonstrate that the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device provide adequate mechanical properties for its use in soft tissue reinforcement." However, specific numerical performance results are not provided.
• Type of study: "Performance Data" section lists several types of tests conducted: Suture Retention Testing, Ultimate Strength Testing, Cyclic Testing, Packaging Testing, and Biocompatibility Testing, along with routine endotoxin (LAL) batch testing. These appear to be laboratory and material science tests, not clinical studies.

The document does not provide information on:

• A table of acceptance criteria and reported device performance with numerical values.
• Sample size used for a test set, data provenance, or whether it was retrospective/prospective.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
• Standalone algorithm performance (as this is a physical medical device, not an AI/software device).
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set or how ground truth for the training set was established.

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

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The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.

The provided text describes the 510(k) summary for the SECURE-LOCK device, a suspensory fixation device for ACL/PCL repair and reconstruction. It outlines the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for clinical efficacy. Instead, it lists various performance tests conducted to demonstrate the device's mechanical properties, safety, and substantial equivalence to a predicate device. The conclusion states that the device provides "appropriate mechanical properties and is relatively safe for its use."

However, based on the tests conducted, we can infer performance areas:

Study Details

The document describes performance testing rather than a clinical study with a test set of human subjects. The assessment is based on bench testing of the device itself and its materials.

2. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" here refers to physical devices and materials undergoing various laboratory tests (tensile strength, fatigue, etc.). There is no mention of the specific number of devices tested for each performance test, but it is implied that representative samples were used. Data provenance is internal laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and material properties is established by recognized engineering and material science standards and measurement techniques, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set: Not applicable for device performance testing against established standards. Results are compared directly to pre-defined specification limits or industry standards (e.g., ISO, USP, ANSI/AAMI).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device 510(k) submission focused on demonstrating substantial equivalence through bench testing and material characterization, not a comparative clinical effectiveness study involving human readers or patient outcomes, especially not in the context of AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device (fixation implant), not a software algorithm or AI device.

7. The type of ground truth used:

   • Mechanical Performance: Engineering specifications, industry standards (e.g., for tensile strength, fatigue, suture properties).
   • Biocompatibility: ISO 10993-1 standards.
   • Pyrogenicity: FDA requirements ( specification limits.
   • MRI Compatibility: Recognized standards for safety in MR environments.

8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Pitch-Patch is a permanent implantable device for reinforcement of rotator cuff tears. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile.

The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.

The provided text describes the 510(k) clearance for the Pitch-Patch Tissue Reinforcement Device. This device is a surgical mesh intended to reinforce the rotator cuff during or after repair.

The information provided focuses on the performance testing conducted to demonstrate the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets them in the context of an AI/software device. The document describes a medical device, not an AI/software device. Therefore, many of the requested points related to AI/software performance criteria (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable or extractable from this document.

However, I can extract information related to the performance studies done for this physical medical device.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense for an AI/software device (e.g., minimum sensitivity, specificity). Instead, it lists the types of performance tests conducted and concludes that the results demonstrate the device's mechanical properties are appropriate and that differences from predicates do not affect safety and efficacy.

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The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.

The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

The XTREME-LOOP device is a soft tissue fastener used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate Ligament (ACL) reconstruction. The device was deemed substantially equivalent to the predicate device, SECURE-LOOP (K151601), based on performance testing. The reported information focuses on the device's physical properties and biological safety rather than clinical performance metrics in the context of diagnostic accuracy or clinical outcomes often seen in AI/ML device submissions.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a "test set" in the context of patient data or image datasets, as this device is a physical implant. The testing described is pre-clinical engineering and biological safety testing. Therefore, information on sample size and data provenance like country of origin or retrospective/prospective nature is not applicable in the way it would be for AI/ML device studies. The sample sizes would pertain to the number of devices or test samples evaluated in the mechanical and biological tests. These specific numbers are not detailed in the summary.

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

This information is not applicable. Ground truth, in the context of expert consensus, refers to a human interpretation of data (e.g., medical images). For a physical medical device like the XTREME-LOOP, the "ground truth" for performance is established through standardized laboratory testing and material characterization, not expert human interpretation.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 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:

This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML diagnostic or therapeutic aid that would involve human readers or AI assistance.

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

This is not applicable. The XTREME-LOOP is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device's performance was established through:

• Mechanical Testing: Standardized engineering tests (strength, stiffness, fatigue, functional testing) comparing the XTREME-LOOP to the predicate device, SECURE-LOOP.
• Biological Safety Testing: Adherence to established standards for pyrogenicity, specifically:
  • Turbidimetric Limulus Amoebocyte Lysate (LAL) method in line with ANSI/AAMI ST72:2011 for endotoxins.
  • Rabbit pyrogenicity test per USP, General Chapter .

8. The sample size for the training set:

This is not applicable. The XTREME-LOOP is a physical device, not an AI/ML model that requires a training set.

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

This is not applicable for the same reasons as point 8.

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The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates.

The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.

The Infinity-Lock™ Button System comprises a permanent implantable 240 mm Tube-Tape and titanium alloy Button together with a disposable cannulated drill bit and guidewire. A coracoid passer, such as the Xiros CCHook, is also required.

This document is a 510(k) Premarket Notification from the FDA regarding the "Infinity-Lock™ Button System," a medical device for bone fixation. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria via a study on its diagnostic performance, as would be the case for an AI/ML medical device.

Therefore, the requested information for acceptance criteria and a study proving the device meets them (especially points 2-9 related to test sets, experts, ground truth, and training sets for an AI/ML device) is not applicable to this submission. This document describes a traditional medical device (implantable system) and its performance is evaluated through mechanical testing against a predicate device.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Reported Device Performance

The document describes performance testing, but not in the framework of diagnostic performance or AI model validation. Instead, it focuses on the equivalence of mechanical properties.

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

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The Infinity-Looks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.

The Infinity-Locks are non-absorbable, sterile, poly(ethylene terephthalate) sutures. They are prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Infinity-Locks differ from USP Sutures in being in the form of woven tapes and in exceeding all USP sizes.

The product comprises two sizes of textile implant based on the Neoligaments poly-tape design. The tapes have an integral loop at one end which are used to tie a cowhitch through one end of a ruptured tendon. The tapes have two tails which are then sutured through the separated end (using methods such as the Bunnell technique), thus drawing the two ends together in order to facilitate healing of the tear. One of the tails has a green stripe to aid identification and both taper into a cord to assist with passing through soft tissues.

This document is a 510(k) premarket notification for a medical device called "Infinity-Lock 3" and "Infinity-Lock 5" surgical sutures. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a diagnostic device. It concerns a mechanical surgical suture. Therefore, many of the requested criteria (such as acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

The "performance data" section in the document refers to mechanical testing of the sutures, not performance in a diagnostic or AI context.

Here's a breakdown of the relevant information provided in the document:

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

The document states: "Mechanical testing was performed on the modified device and original poly-tape in both knotted and unknotted conditions to determine the ultimate tensile strengths using an internal method, QT010, and following USP 39 NF33:2016 for non-absorbable surgical sutures, where applicable. The modified devices were found to be equivalent or superior in all cases."

While specific numerical acceptance criteria and performance values are not explicitly tabulated in this summary, the statement indicates that the new device met or exceeded the performance of the predicate device based on tensile strength tests. The standard followed, USP 39 NF33:2016, would contain the specific criteria.

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

• Sample Size: Not explicitly stated for the mechanical testing.
• Data Provenance: The testing was "internal" (Xiros Ltd.) as per method QT010.
• Retrospective or Prospective: This type of mechanical testing is typically a prospective validation of manufactured samples.

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

• Not applicable for this type of mechanical device. "Ground truth" for mechanical properties is established through standardized physical measurements and tests, not expert interpretation of diagnostic data.
• There was "Validation... undertaken by clinicians using cadaveric materials to demonstrate the suitability of the modified device for the intended use." This is about usability and fit-for-purpose, not diagnostic ground truth. The number and qualifications of these clinicians are not specified in this summary.

4. Adjudication method for the test set:

• Not applicable for this type of mechanical device. Mechanical tests have objective, measurable outcomes.

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/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used:

• For mechanical properties: Objective physical measurements (ultimate tensile strength) against standards (USP 39 NF33:2016).
• For usability: Clinician assessment on cadaveric materials.

8. The sample size for the training set:

• Not applicable. This is a manufactured medical device, not an AI model requiring a "training set."

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

• Not applicable. See point 8.

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The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

The provided text describes the SECURE-LOOP device and its substantial equivalence to a predicate device, the Smith & Nephew Endobutton Continuos Loop (ECL) K980155. It focuses on comparing the technological characteristics and performance of the SECURE-LOOP with the predicate device rather than presenting specific acceptance criteria and a study to prove they are met in a traditional sense.

Instead of a typical AI/ML device study, the document describes a device equivalency study based on pre-clinical testing for a medical fastener.

Here's an analysis based on the information provided, formatted to answer your questions where applicable:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds. Instead, the criterion for the SECURE-LOOP device is substantial equivalence to the predicate device (Smith & Nephew Endobutton Continuos Loop (ECL) K980155) across several performance characteristics.

Study Details:

1. Sample size for the test set and data provenance:
   The document does not specify the exact sample sizes (i.e., number of devices or test repetitions) used for the stiffness, tensile strength, cyclic fatigue, and functional testing.
   The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond stating "pre-clinical testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable as the study involves device performance testing against a predicate, not human expert interpretation for ground truth establishment.

3. Adjudication method for the test set:
   Not applicable, as it is a physical device performance comparison, not a ground truth establishment process involving multiple experts.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
   No, an MRMC study was not done. This type of study is typically for diagnostic imaging devices involving interpretation by multiple human readers, which is not relevant for this orthopedic fixation device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This question is generally relevant for AI/ML algorithms. For this physical device, the "standalone performance" is implicitly what was measured in the pre-clinical tests (stiffness, tensile strength, cyclic fatigue, functional testing) where the device's properties were characterized without human intervention in its function.

6. The type of ground truth used:
   The "ground truth" in this context is the established performance characteristics of the predicate device which the SECURE-LOOP device is attempting to demonstrate equivalence to. The performance parameters (stiffness, tensile strength, cyclic fatigue, functional performance) of both the SECURE-LOOP and the predicate device are determined through laboratory-based physical/mechanical testing.

7. The sample size for the training set:
   The concept of a "training set" is not applicable here as this is not an AI/ML device. The testing described is for performance validation, not for training a model.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI/ML model.

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