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The OSSIOfiber® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; Specifically:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Knee: Repair/Reconstruction of the Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band Tenodesis, MPFL
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The OSSIOfiber® Interference Screw is an orthopedic implant made of poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The OSSIOfiber® Interference Screws are cannulated and fully threaded, available in diameters ranging from 6 to 12 mm and lengths from 23 to 28 mm. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the implantation site. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Interference Screw is supplied sterile, for single patient use only.

The OSSIOfiber® Interference Screw is designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentation such as ISO 9714 compatible instrumentations.

This document does not describe a study that uses AI or machine learning. It describes a medical device called the OSSIOfiber® Interference Screw and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical (laboratory/mechanical) testing rather than clinical studies with human subjects or AI performance evaluations.

Therefore, many of the requested categories for AI/ML study acceptance criteria and performance data cannot be filled from the provided text.

Here's an analysis of what information can be extracted or inferred from the text related to the device's acceptance criteria and study, with explanations for the missing AI/ML specific data:

Device: OSSIOfiber® Interference Screw

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) clearance letter does not specify explicit numerical acceptance criteria in the typical format (e.g., "pull-out strength > X N"). Instead, it states that the device was found to be "at least as safe and effective" and demonstrated "at least equivalent performance" to the predicate devices. The performance is assessed comparatively.

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

• Sample Size: Not explicitly stated. The document mentions "Pull-out testing," "Torsional strength," and "driving torque testing" but does not provide the number of samples tested for each.
• Data Provenance: The studies are "non-clinical data" and "in-vitro degradation." This implies laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submitter is "Ossio Ltd." in Caesarea, Israel. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission, not gathered retrospectively from patient treatments.

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

Not applicable. This information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). The described studies are non-clinical (mechanical and biocompatibility testing). Ground truth in this context would be defined by standard engineering and biocompatibility testing protocols, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described because the studies are non-clinical engineering tests.

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 a medical device clearance based on non-clinical performance and substantial equivalence, not an AI/ML diagnostic or assistive software. There is no AI component described.

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

Not applicable. This section is for AI/ML algorithms. No such algorithm is described.

7. The Type of Ground Truth Used

For mechanical testing (pull-out, torsional strength, driving torque): The "ground truth" is established by direct physical measurement according to validated test methods and engineering standards. The performance of the predicate device serves as the benchmark for comparison.

For biocompatibility: Ground truth is established by the results of ISO 10993 testing, which uses established biological endpoints and criteria.

8. The Sample Size for the Training Set

Not applicable. This is for AI/ML studies. No training set is mentioned as there is no AI/ML component.

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

Not applicable. This is for AI/ML studies.

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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 – 5.5 Anchors only).
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

The provided FDA 510(k) clearance letter and summary for the OSSIOfiber® Suture Anchor (K251309) primarily focus on non-clinical performance data to support substantial equivalence. It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnosis/treatment. Instead, it details a mechanical device and its performance for surgical fixation.

Therefore, many of the requested elements pertaining to AI, human readers, ground truth establishment for clinical data, and training/test set samples for AI models are not applicable to this specific submission.

However, we can extract information regarding the acceptance criteria and the study (non-clinical) that proves the device meets the acceptance criteria as presented in the document.

Analysis of Acceptance Criteria and Device Performance (Non-Clinical)

The submission for the OSSIOfiber® Suture Anchor (K251309) is a Special 510(k) premarket notification to expand the existing indications for use to include "Meniscal Root Repair." The core of the justification for substantial equivalence relies on demonstrating that the device's performance for this new indication is comparable to its predicate devices, primarily through non-clinical (mechanical) testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table with numerical acceptance criteria and corresponding reported device performance values in the format typically seen for clinical or AI studies. Instead, the "acceptance criteria" are implied by demonstrating equivalent or superior mechanical performance to the predicate devices for critical aspects relevant to a suture anchor (e.g., fixation strength, degradation characteristics).

The study that proves the device meets (or aligns with) these implied criteria is the non-clinical testing previously conducted and referenced.

Note: The document only provides meta-information about the testing (that it was done, and what kind), not the raw numerical results or specific acceptance thresholds. The "rationale" refers to the interpretative analysis of that data.

2. Sample Size and Data Provenance (for the mechanical test)

• Sample Size: The document states that the rationale for the new indication was "based on the comparative static pull-out and cyclic pull-out testing included within K213415." However, the exact sample sizes (e.g., number of anchors tested, number of cycles) for the static and cyclic pull-out tests are not specified in this 510(k) summary. This information would typically be found in the full test reports referenced in the initial K213415 predicate submission.
• Data Provenance: The testing is non-clinical (laboratory-based mechanical testing). It's not data from human subjects or collected from real-world patients. The origin of the data is from the device manufacturer's (Ossio Ltd.) internal testing, likely at a certified testing facility.
  • Country of Origin: Not explicitly stated for the testing, but Ossio Ltd. is based in Caesarea, Israel.
  • Retrospective or Prospective: This distinction doesn't fully apply to mechanical testing in the same way it does to clinical studies. The tests were performed prospectively according to established protocols to generate data for regulatory submission.

3. Number of Experts and their Qualifications (for mechanical testing)

This question is Not Applicable in the context of this mechanical device submission, as the "ground truth" is established through physical measurements and engineering principles, not expert human interpretation like in AI/imaging studies. The "experts" involved would be engineers and technical specialists conducting and analyzing the mechanical tests according to industry standards.

4. Adjudication Method (for mechanical testing)

This question is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in human expert interpretations (e.g., radiology reads). For mechanical testing, the "ground truth" is directly measured, and results are verified through standard quality control and robust test methodologies.

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

Not Applicable. This is a question relevant to AI-assisted diagnostic or imaging devices, not a mechanical surgical implant. No human readers or AI assistance in interpretation are involved in the use or evaluation of a suture anchor.

6. Standalone (Algorithm Only) Performance

Not Applicable. This would apply to AI algorithms. The OSSIOfiber® Suture Anchor is a physical medical device, not an algorithm.

7. Type of Ground Truth Used (for the mechanical testing)

• The "ground truth" for this device's performance is established through physical, quantifiable measurements from standardized mechanical tests.
  • Static Pull-out: The maximum force required to pull the anchor out of simulated bone material.
  • Cyclic Pull-out: The anchor's resistance to displacement or failure under repeated loading cycles.
  • Material Degradation: Chemical and physical analysis of the material over time (e.g., mass loss, molecular weight changes, mechanical property retention).
• It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set (for a mechanical device)

Not Applicable. This concept applies to machine learning models. For a mechanical device, there isn't a "training set" in the AI sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training on data.

9. How the Ground Truth for the Training Set was Established (for a mechanical device)

Not Applicable. As there is no AI training set, this question is not relevant. The "truth" about the materials and design comes from established scientific and engineering principles, material characterization, and prior performance data of similar devices and materials. The non-clinical data demonstrates the performance of the final device, not establishes ground truth for a training set.

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The Knotilus+ Biocomposite Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction
• Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
• Hip: Acetabular Labral Repair

2.4x8.9mm:

• Hip: Acetabular Labral Repair

The Knotilus+ Biocomposite Knotless Anchors are hard-body, push-in, knotless bone anchors. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and poly-L-lactide ("PLLA") and beta-tricalcium phosphate ("β-TCP") anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

It appears there has been a misunderstanding. The FDA 510(k) clearance letter you provided is for a Knotilus+ Biocomposite Knotless Anchor, which is a medical device used for soft-tissue to bone fixation. This is a physical, implantable device, not a software or AI-driven diagnostic tool.

The questions you've asked (about acceptance criteria, test set sample sizes, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) are highly relevant to the validation of Artificial Intelligence (AI) or machine learning (ML) medical devices, particularly those performing image analysis or diagnostic functions.

Since the provided document describes a physical bone anchor device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance metrics (like sensitivity, specificity, AUC, etc., derived from test sets and human expert evaluations) does not apply.

For a physical device like a bone anchor, "acceptance criteria" would typically relate to:

• Mechanical properties: E.g., Ultimate Tensile Strength (UTS), pull-out strength, fatigue life, torsional strength.
• Biocompatibility: Absence of adverse tissue reactions.
• Sterility: Ensuring the device is free from microorganisms.
• Dimensional accuracy: Conforming to design specifications.
• Material properties: Chemical composition, degradation rates (for biocomposite materials).

The document states that "Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ Biocomposite Knotless Anchor, including ultimate tensile strength (UTS), UTS after Cyclic Loading, UTS after Degradation, and insertion testing." It also mentions "Bacterial endotoxin testing." These are the types of studies that prove this device meets its performance and safety acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device validation based on the provided document because it describes a different class of medical device.

If you have a document related to an AI/ML medical device, please provide that, and I will be happy to answer your questions accordingly.

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The Stryker AlphaVent™ Knotless SP Biocomposite Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

The AlphaVent Knotless SP Biocomposite Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and a biocomposite (Poly-L-lactic Acid (PLLA)/beta-tricalcium phosphate (β-TCP)) anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone either via a self-punching mechanism or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

This FDA 510(k) clearance letter is for a medical device (Stryker AlphaVent™ Knotless SP Biocomposite Anchor), not an AI/ML medical device. Therefore, a significant portion of the requested information (items 2-5, 7-9) is not applicable as these relate specifically to studies conducted for AI/ML performance evaluation.

However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this physical medical device.

Acceptance Criteria and Study for Stryker AlphaVent™ Knotless SP Biocomposite Anchor

Based on the provided FDA 510(k) summary, the device is a physical implant, and its performance is evaluated through non-clinical benchtop testing. The acceptance criteria are implicitly defined by demonstrating equivalence or superiority to predicate devices in key performance areas.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the non-clinical benchtop testing (e.g., number of anchors tested for UTS or insertion). The testing is described as "non-clinical benchtop testing," which implies laboratory-based experiments rather than human or animal studies. Therefore, provenance such as country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical implant, and its performance is assessed through objective, quantitative, non-clinical benchtop tests, not through expert interpretation of data or images.

4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective physical measurements and comparisons, not through adjudication by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not an AI/ML device that assists human readers.

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

7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective physical measurements and laboratory standards. For example:

• Ultimate Tensile Strength (UTS): Measured in a lab using force-testing equipment against established engineering standards and comparison with predicate device performance.
• Insertion Performance: Evaluated against defined mechanical parameters and successful deployment in simulated "worst-case" conditions.
• Bacterial Endotoxin Testing: Measured against predefined regulatory limits for endotoxin levels (e.g., ISO or USP standards).

8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" for an AI/ML algorithm.

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The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Specific indications are listed below:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcromioClavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure

• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

The OSSIOfiber® Suture Anchor 2.5-3.5 mm, consists of an anchor preloaded on an inserter. The anchor is made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are supplied sterile, for single patient use only.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is an FDA 510(k) clearance letter and its associated 510(k) Summary. It describes a medical device, the OSSIOfiber® Suture Anchor 2.5-3.5 mm, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics that would typically apply to AI/ML or diagnostic devices.

The document focuses on demonstrating substantial equivalence for a physical implantable device, which relies on comparing its technological characteristics (intended use, materials, design, principles of operation, manufacturing, sterilization) and performance (mechanical testing, biocompatibility) to already cleared devices. It does not involve a diagnostic or predictive algorithm, thus many of the criteria requested (e.g., test set sample size, expert ground truth, MRMC study, standalone performance) are not applicable.

Here's an analysis based on the information provided, highlighting the differences in context:

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

Since this is a physical medical device clearance, the "acceptance criteria" are not reported as specific numerical benchmarks for diagnostic performance (like sensitivity or specificity). Instead, they relate to demonstrating comparable safety and effectiveness through a combination of:

• Technological Characteristics: The device must have substantially similar or identical intended use, principles of operation, material composition, design, manufacturing, and sterilization methods as predicate devices.
• Performance (Non-Clinical): Mechanical properties (strength, fixation) and biological response (biocompatibility) must be at least equivalent to the predicate device.

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

• Test Set Sample Size: The document does not specify a "test set sample size" in the context of diagnostic performance. For mechanical testing, the number of devices or constructs tested for static and cyclic pull-out is not explicitly stated. The "in-vitro degradation profile" was characterized, but the sample size for this is also not given.
• Data Provenance: The mechanical testing and degradation characterization were performed "in-vitro." Biocompatibility was established based on ISO 10993 data from previously cleared devices and rationales. This suggests laboratory-based testing and references to existing, accepted data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. The device is a surgical implant, not a diagnostic tool requiring expert interpretation of images or data to establish a "ground truth" for a test set. The "ground truth" for a device like this would be established through established engineering and biological standards and clinical experience with predicate devices.

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

This is not applicable as there is no diagnostic or interpretive test set requiring adjudication in this context.

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. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is relevant or mentioned.

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

This is not applicable. This is a physical implantable device, not an algorithm.

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

For this type of device, the "ground truth" is typically defined by:

• Established engineering standards: Performance metrics like pull-out strength, cyclic fatigue, and degradation rates are measured against accepted industry standards or the performance of legally marketed predicate devices, which are deemed safe and effective.
• Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices, which typically involves in-vitro and/or in-vivo testing, leading to a conclusion of acceptable biological risk.
• Clinical history of predicate devices: The "ground truth" for safety and effectiveness is largely based on the long-term clinical use and acceptance of the predicate technologies (similar design, materials, surgical indications).

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this 510(k) submission.

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

This is not applicable, as there is no training set.

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The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder. Specifically, rotator cuff repairs.

The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a fully threaded knotless suture anchor that is pre-loaded on a disposable inserter with Arthrex sutures. The anchor may be manufactured from either BioComposite (PLLA/betaTCP TriCalcium Phosphate) or PEEK (Polyether-ether-ketone). The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is provided sterile (Ethylene Oxide), single-use, and is packaged in a single-pack or 5-pack.

The provided document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The "Performance Data" section of the 510(k) summary (page 4) states:
"Tensile (pull-out) testing was conducted on the proposed Arthrex 4.75 mm Doubled Loaded Knotless Corkscrew Suture Anchor submitted in this Special 510(k). The test data demonstrates that the proposed device performs statistically equivalent to the predicate device for the intended indications for use. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that mechanical and biocompatibility tests were performed, but no acceptance criteria or detailed study results for an AI/ML device performance are present. The document is for a physical medical device (suture anchor), not an AI/ML-driven diagnostic or therapeutic tool. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML system cannot be extracted from this document.

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The GRYPHON X Anchor is intended for:
Shoulder: Biceps Tenodesis;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament Reconstruction;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction

The HEALIX TRANSTEND Anchor is intended for:
Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Lateral Epicondylitis Repair;
Wrist: Scapholunate Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair

The subject devices of this Traditional 510(k) are the GRYPHON X Anchors and the HEALIX TRANSTEND Anchors.

The proposed GRYPHON X Anchor is suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture to bone for various orthopedic procedures. The proposed anchor will be available with various suture offerings: ORTHOCORD™ Suture, PERMACORD™ Suture, DYNACORD™ Suture, and PERMATAPE™ 1.3mm Suture, offered in either single strand or double strand configurations with needle attachments. The GRYPHON X Anchors are offered with either a push-in (“P”) or threaded (“T”) anchor design and are available in absorbable BIOCRYL RAPIDE (BR) (P and T anchors) or non-absorbable PEEK materials (P anchors only). The implant is supplied sterile, ready to use.

The proposed HEALIX TRANSTEND Anchor is a suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture bone for various orthopedic procedures. This proposed device will be loaded with either one or two strands of PERMATAPE 1.3mm Suture and will be offered in PEEK material only. The implant is supplied sterile ready to use.

The proposed GRYPHON X product portfolio also contains a reusable instrument sterilization tray with lid (sold separately) – it's intended to store and protect the reusable instruments during transport and sterilization

This document is an FDA 510(k) Premarket Notification for orthopedic bone fixation devices (suture anchors). It details the substantial equivalence of the GRYPHON™ X Anchor and HEALIX TRANSTEND™ Anchor to existing predicate devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that, for the purpose of this FDA clearance, the new devices (GRYPHON X and HEALIX TRANSTEND anchors) are considered as safe and effective as the already-marketed predicate devices. The basis for this determination is laid out in the acceptance criteria and non-clinical testing section below.

Regarding the specific requirements for "device meets the acceptance criteria" as requested in your prompt, it's important to understand that for a 510(k) submission like this, the "acceptance criteria" are primarily defined by:

1. Substantial Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
2. Performance Testing: Providing data from non-clinical (and sometimes clinical, though not typically required for Class II 510(k)s unless new questions of safety/effectiveness are raised) tests to support the substantial equivalence claim.

Therefore, the "acceptance criteria" table below will reflect the comparative aspects and performance tests mentioned in the document.

1. Table of Acceptance Criteria and Reported Device Performance

• Anchor design
• Materials
• Principle of operation
• Intended use | The anchor design, materials, principle of operation, and intended use of the subject devices are identical to that of the predicate devices. The main differences are additional suture configurations and additional indications for use (GRYPHON X only), which are addressed by the non-clinical testing. |
  | Performance - Fixation Strength:
• At T=0 (initial fixation)
• Over healing period (for absorbable materials) | Verification activities included an assessment of fixation strength for proposed indications at T=0 and over the healing period (for absorbable configuration). The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Performance - Insertion Force | Verification activities included an assessment of insertion force. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Performance - Fatigue Strength | Verification activities included an assessment of fatigue strength. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Performance - Needle Attachment Strength (for pre-loaded sutures) | Verification activities included an assessment of needle attachment strength for the pre-loaded sutures in scope of the submission. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria. |
  | Overall Safety and Effectiveness - No New Issues | Results of the analyses demonstrated that there were no new issues of safety or effectiveness related to device performance. |

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

The document does not explicitly state the numerical sample sizes used for the non-clinical testing (e.g., number of anchors tested for fixation strength, insertion force, etc.). It generally refers to "verification activities" and "analyses" demonstrating that the devices meet criteria.
The data provenance is non-clinical testing, performed to support product safety and performance, typically done in vitro (bench testing). The document does not provide details on the location/country of origin of this data or if it's retrospective or prospective, but for 510(k) non-clinical testing, it is always prospective, often conducted by the manufacturer or a contract research organization.

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

• For this type of 510(k) submission, there isn't a "ground truth" derived from expert clinical assessment in the same way as, for example, an AI/imaging device. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices.
• Expert involvement for establishing ground truth (e.g., radiologists for imaging studies) is not applicable or described in this document for these mechanical orthopedic implants. The "experts" involved are likely engineers, material scientists, and regulatory affairs professionals who conducted and reviewed the bench testing against predefined engineering specifications and regulatory standards. Their specific number or qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

• Since this is primarily non-clinical, bench testing, adjudication methods (like 2+1, 3+1 concensus for clinical interpretations) are not applicable. The device performance is measured against engineering specifications and industry standards for mechanical properties.
• Any "adjudication" would involve internal quality control and regulatory review processes, rather than interpretation of clinical data by multiple experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those that involve human interpretation of images (e.g., AI in radiology).
• The devices in this submission are mechanical orthopedic implants (suture anchors). Their effectiveness is proven through biomechanical testing (fixation strength, fatigue, etc.) and by demonstrating substantial equivalence to currently marketed devices, not through human reader performance.

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

• Not applicable. This question pertains to AI/software devices. The devices submitted are physical medical implants (suture anchors), not algorithms.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is implicitly established by engineering specifications, industry standards relevant to orthopedic implants, and the performance characteristics of the identified predicate devices.
• The tests performed (fixation strength, fatigue strength, insertion force, needle attachment strength) are benchmarked against what is considered acceptable for such devices on the market. The statement "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria" confirms this.
• There's no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense being used as ground truth for this mechanical device.

8. The Sample Size for the Training Set

• Not applicable. This question is typically relevant for machine learning or AI models, which require training data. The devices in this submission are mechanical orthopedic implants. They do not involve "training sets" in the computational sense.

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

• Not applicable. As explained in point 8, there is no "training set" for these mechanical devices.

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The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The provided text is an FDA 510(k) clearance letter for a medical device called "Fix2Lock" (a bone anchor). This type of document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data (bench tests). It does not contain information about clinical studies involving human patients, human readers (e.g., radiologists interpreting images), or AI algorithms for diagnostic purposes.

Therefore, I cannot provide details on:

• Acceptance criteria related to AI performance (e.g., sensitivity, specificity).
• Sample sizes for test sets or data provenance for AI.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI performance.
• Training set details for AI.

The document discusses bench testing to demonstrate the device's mechanical and material properties, and sterility, compared to existing standards and a predicate device.

Here's the information that can be extracted relevant to the performance and acceptance criteria for this specific type of medical device, which is a bone anchor, not an AI diagnostic tool:

Acceptance Criteria and Study for the Fix2Lock Device

The acceptance criteria and supporting studies for the Fix2Lock device are based on non-clinical (bench) testing, primarily to demonstrate that the device meets established material and mechanical performance standards and is substantially equivalent to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample sizes (number of units) used for each bench test. However, it indicates that "Bench tests were conducted to verify that the subject device met all design specifications."
• Data Provenance: Not applicable in the human patient context. The data is from laboratory bench testing of the physical medical device. The sponsor is OSTEONIC Co., Ltd. from Korea, South. The testing would have been conducted by or for the manufacturer.

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 this type of device is established through compliance with recognized consensus standards (e.g., ASTM, ISO) and comparison of physical/mechanical properties to a predicate device via laboratory testing, not through expert human interpretation of data like in an AI study.

4. Adjudication method for the test set:

• Not applicable. Bench tests have objective, measurable endpoints based on engineering and material science principles, not subjective interpretation requiring 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:

• No. This is a physical medical device (bone anchor), not an AI diagnostic software.

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

• No. This applies to AI algorithms, not physical implanted devices.

7. The type of ground truth used:

• The "ground truth" for this device is compliance with established engineering, material, and sterilization standards (ASTM and ISO standards) and demonstration of equivalent performance characteristics (material, mechanical, sterilization properties) compared to a legally marketed predicate device through objective bench testing.

8. The sample size for the training set:

• Not applicable. There is no AI training set for this physical device.

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

• Not applicable. There is no AI training set.

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HEALIX ADVANCE Knotless anchors:
The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair

The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair
• · Foot and Ankle: Lateral Stabilization
• · Foot and Ankle: Medial Stabilization

HEALIX ADVANCE Self-Punching anchors:
The DePuy Mitek HEALIX ADVANCE SP Biocomposite Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair

The DePuy Mitek HEALIX ADVANCE SP PEEK Anchors is indicated as follows:

• · Shoulder: Rotator Cuff Repair
• · Shoulder: Bicep Tenodesis
• · Shoulder: Deltoid Repair
• · Elbow: Ulnar Collateral Ligament (UCL)
• · Elbow: Radial Collateral Ligament (RCL)
• · Knee: Posterior Oblique
• · Knee: Medial Collateral Ligament (MCL)
• · Knee: Lateral Collateral Ligament (LCL)
• · Knee: liotibial (IT) Band Tenodesis
• · Knee: Anterior Cruciate Ligament (ACL) Repair
• · Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair
• · Knee: Meniscal Root Repair
• · Foot and Ankle: Achilles Tendon Repair
• · Foot and Ankle: Lateral Stabilization
• · Foot and Ankle: Medial Stabilization

The subject devices of this Special 510(k) are the HEALIX ADVANCE Knotless anchors and HEALIX ADVANCE Self-Punching (SP) anchors.

The HEALIX ADVANCE Knotless Anchor is a one-piece implantable cannulated, threaded anchor designed to secure soft tissue to bone utilizing suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a #2 ORTHOCORD stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and violet Polydioxanone (PDS). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The anchor is provided preloaded on a single-use driver. The anchor is offered in three sizes: 4.75mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocryl Rapide® (BR) and Polyetheretherketone (PEEK) materials. The Biocryl Rapide material is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP. The HEALIX ADVANCE KNOTLESS Anchor is provided sterile and is for single use only.

The HEALIX ADVANCE SP Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator designed to secure soft tissue to bone utilizing suture (provided separately). The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation, the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The HEALIX ADVANCE SP Anchor is offered in three sizes: 4.9mm, 5.5mm and 6.5mm. The anchors are available in two materials: Biocomposite (Biocryl) and Polyetheretherketone (PEEK) material. Biocryl is an absorbable biocomposite of Polylactic Acid (PLA) and Tricalcium Phosphate (TCP). The HEALIX ADVANCE SP Anchor is provided sterile and is for single use only.

The provided text is a 510(k) summary for medical devices, specifically suture anchors. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on a study designed to establish acceptance criteria for a new device's performance. Therefore, most of the requested information regarding acceptance criteria and performance study details for a new device is not present in this document.

However, I can extract what is available and clarify what is missing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance in the format usually associated with a clinical or detailed performance study. The "Non-clinical Testing" section broadly states that "Verification activities were performed on the proposed device. Verification included an assessment of fixation strength for proposed indications at T=0 and over the healing period, as well as assessment of insertion force." The "Safety and Performance" section concludes that "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria, and that there were no new issues of safety or effectiveness related to device performance."

This suggests that the "acceptance criteria" were the "established design inputs and corresponding criteria" that the devices were verified against, and the "reported device performance" was that they met these criteria. However, no specific metrics, thresholds, or quantitative results are provided in this summary.

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

The document states that "Verification activities were performed on the proposed device," which would constitute the "test set" for these non-clinical tests. However, it does not specify the sample size used for these tests (e.g., how many anchors, how many iterations).

The data provenance is non-clinical/bench testing, likely performed in-house by the manufacturer (DePuy Synthes Mitek Sports Medicine) or a contracted lab. There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to human subject studies.

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

This information is not applicable or not provided in this type of submission. The "ground truth" for non-clinical performance tests usually refers to objective measurements and established engineering or biomechanical principles, not expert consensus as would be used in diagnostic imaging or clinical outcome studies.

4. Adjudication Method for the Test Set

This is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) establishing ground truth in subjective assessments, such as interpreting medical images. For non-clinical device performance testing, objective measurements are typically taken, and any discrepancies would be resolved through standard engineering verification and validation protocols, not through expert adjudication in this sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No MRMC comparative effectiveness study was mentioned or conducted as this is a submission for a physical medical device (suture anchors), not a diagnostic algorithm or a device requiring human interpretation for its primary function.

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

This is not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical (bench) testing, the "ground truth" would be the objective measurements obtained from testing the fixation strength and insertion force of the anchors, compared against the pre-defined engineering specifications and design inputs. This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this type of non-clinical device performance testing. Training sets are relevant for machine learning algorithms.

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

This is not applicable, as there is no training set for this type of submission.

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