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The Parcus Miti Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

The Parcus V-lox™ Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip: Acetabular Labral Repair

The Parcus Miti and V-lox Titanium Suture Anchors are a family of threaded, tapered fasteners for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with either one, two, or three strands of sutures between 3-0 and #2 in size or suture tape between 1.4mm and 2.0mm wide. The suture and suture tape is available either with or without attached needles, and is provided sterile and attached to a driver. The Miti Suture Anchor is available in diameters of 2.0mm, 2.5mm and the V-lox Titanium Suture Anchor is available in diameters of 4.5mm, 5.0mm, 5.5mm and 6.5mm.

The provided text describes a 510(k) premarket notification for Parcus V-lox Titanium Suture Anchors and Parcus Miti Suture Anchors. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with a new AI/software device. Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of why the requested information cannot be fully provided based on the input:

• Type of Device: The devices are physical implants (suture anchors), not an AI or software device. The "performance data" section focuses on MR (Magnetic Resonance) compatibility, which is a safety evaluation for implanted medical devices, not an evaluation of diagnostic or treatment efficacy based on AI algorithms.
• Regulatory Pathway: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. This often involves comparing device specifications, materials, and intended use, and sometimes includes performance testing for specific safety attributes (like MR compatibility here), rather than clinical efficacy studies against acceptance criteria for a new mode of action.

Given this context, I will address the requested points as much as possible, clarifying where the information is not present due to the nature of the submission.

Acceptance Criteria and Device Performance

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

The document does not provide a table of acceptance criteria for diagnostic performance or treatment efficacy. The only performance data presented relates to MR compatibility.

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

The document mentions "worst-case devices were selected for testing" for MR compatibility. However, it does not specify the exact sample size (number of devices tested) for the MR evaluation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) as this was a laboratory-based physical test on the device itself, not a clinical data study.

• 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 point is not applicable. The MR compatibility testing is a physical measurement of the device's interaction with an MR environment, not a diagnostic or clinical assessment requiring expert consensus or ground truth in the medical sense.

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

This point is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for physical performance testing like MR compatibility.

• 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 point is not applicable. The device is a physical medical implant (suture anchor), not an AI or software system 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 point is not applicable. The device is a physical medical implant, not an algorithm.

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

For the MR compatibility testing, the "ground truth" would be the scientifically established physical limits and behaviors for MR safety as defined by FDA guidance and ASTM standards. It's a technical standard, not a medical "ground truth" derived from patient data.

• 8. The sample size for the training set

This point is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This point is not applicable. There is no training set.

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The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

The ALLthread Titanium Suture Anchor is a non-resorbable suture anchor used to provide soft tissue fixation to bone during healing.

This document is a 510(k) premarket notification for the ALLthread™ Titanium Suture Anchor, a medical device for soft tissue reattachment, and not a study describing the acceptance criteria and performance of an AI product. Therefore, I cannot extract the requested information. The document focuses on establishing substantial equivalence to predicate devices based on non-clinical testing of mechanical properties and sterility.

Here's why the requested information cannot be found:

• No AI component: The device described is a physical medical implant (suture anchor), not an AI-powered diagnostic or assistive tool.
• Non-clinical testing: The "Summary of Performance Data" details non-clinical tests (cyclic loading, static loading, insertion torque, failure torque, needle attachment strength, suture tensile strength, bacterial endotoxins). These tests assess the physical properties and safety of the anchor itself, not the performance of an algorithm.
• No "acceptance criteria" in the AI sense: The document's closest equivalent to "acceptance criteria" are the performance levels achieved in the non-clinical tests, indicating the device performs "within the intended use" and does "not raise any new risks to device performance." These are not acceptance criteria for an AI model's accuracy, sensitivity, specificity, etc.
• No ground truth, training data, or expert adjudication: Since there's no AI algorithm, there's no concept of ground truth, training set, test set, expert readers, or adjudication methods as they relate to AI performance evaluation.
• No MRMC study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is specific to evaluating AI's impact on human performance, which is not applicable here.

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The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction

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

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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis

Hip: Capsular repair, acetabular labral repair

The Titanium Suture Anchor is a titanium alloy threaded device designed to attach soft tissues to bone when used in conjunction with suture.

This is a 510(k) summary for a medical device called the Titanium Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of diagnostic or AI-driven devices.

Here's a breakdown of the information provided, tailored to your request, but acknowledging the nature of this particular submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (Titanium Suture Anchor), the "acceptance criteria" are related to mechanical performance and demonstrating equivalence to a predicate device. The document does not describe a clinical study comparing the device against specific clinical outcome metrics with statistical acceptance thresholds as one might see for a diagnostic tool or an AI algorithm. Instead, it relies on nonclinical mechanical testing.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a nonclinical testing program.

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

• Sample Size: Not explicitly stated as a numerical value (e.g., N=X units). The document states, "All testing was performed on test units representative of finished devices." This implies multiple units were tested for each type of nonclinical test.
• Data Provenance: Not applicable in the traditional sense of patient data. The "data" comes from laboratory mechanical testing of manufactured device units. It is not patient-derived or clinical.

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

Not applicable. For mechanical tests of a physical device, ground truth is established by engineering standards, test methods, and measurement equipment, rather than expert interpretation of data. The expertise resides in the engineers and technicians performing and validating the tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies, typically in clinical readings or image analysis. Mechanical testing results are objective measurements.

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 physical medical device (suture anchor), not an AI diagnostic or assistive technology. No MRMC study was conducted or is relevant for this type of submission.

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

Not applicable. This is a physical medical device. There is no algorithm to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests is based on engineering specifications, established test methods, and measurable physical properties deemed acceptable for a device of its type and in comparison to its predicate device. This is the closest equivalent to ground truth for this kind of submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense. The "design" of the device is developed through engineering principles, prototyping, and iterative testing, not through a data-driven training process.

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

Not applicable, as there is no training set for an AI algorithm. The device's design is validated against engineering requirements and established safety/performance standards for similar devices.

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The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

• Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
• Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair. Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
• Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
• Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

The Parcus MiTi Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136). The product family includes devices that come preloaded with either one or two sutures between #3-0 and #2 in size either with or without attached needles, and a driver, and is available in three different diameters, 2.0mm, 2.5mm and 3.5mm. The 2.0mm anchor is offered in the following suture configurations: two #3-0 and one or two #2-0 sutures. The 2.5mm anchor is offered in the following suture configurations: two #3-0, two #2-0 and one #2 sutures. The 3.5mm anchor is offered in the following suture configurations: two #3-0, two #1 and two #2 sutures. All configurations are offered in multiple color variations and with or without attached needles.

The provided text describes a 510(k) summary for the Parcus MiTi Suture Anchor, focusing on its substantial equivalence to predicate devices rather than a detailed study demonstrating quantitative acceptance criteria. Therefore, several of the requested sections (sample size, expert ground truth, adjudication method, MRMC studies, specific acceptance criteria table, training set details) cannot be fully populated from this document.

However, based on the Summary Performance Data section, we can infer the acceptance criteria are related to mechanical performance (pull-out strength and insertion torque) and that the device meets these by demonstrating no significant difference compared to predicate devices.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified in the document.
• Data Provenance: Not specified, but the testing would likely have been conducted by Parcus Medical, LLC (based in Sturgeon Bay, WI, USA) or a contracted lab. The study is prospective in nature as it involves physical testing of the device.

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 information is not applicable to this type of mechanical device testing. "Ground truth" in this context is the physically measured pull-out strength and insertion torque.

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

• This information is not applicable to objective mechanical device testing.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a physical medical device like a suture anchor.

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

• Yes, the performance data provided is for the device as a standalone product. The "pull out strength and insertion torque was measured for the Parcus MiTi Suture Anchors" directly, and compared to predicate devices.

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

• The ground truth for the test set was objective physical measurements of pull-out strength and insertion torque obtained through laboratory testing.

8. The sample size for the training set

• This concept is not applicable as this is not an AI/ML device requiring a training set.

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

• Not applicable.

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The Titan Ti Suture Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, 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/Tendon Repair, Bunionectomy;
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction;
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
• Hip: Capsular Repair, Acetabular Labral Repair

The Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with MagnumWire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles.

The provided text describes a 510(k) summary for the ArthroCare® Corporation Titan™ Ti Suture Anchor. This document details the device's substantial equivalence to predicate devices, focusing on physical and mechanical performance testing rather than clinical study data involving human or expert-derived diagnoses.

Therefore, many of the requested fields regarding acceptance criteria, study design, and ground truth in the context of diagnostic or AI performance are not applicable to this type of device submission. The submission relies on establishing substantial equivalence through engineering and material performance comparison and does not involve AI or diagnostic interpretation.

However, I can extract the information relevant to the types of studies mentioned and present it in the requested format.

Acceptance Criteria and Device Performance for ArthroCare® Corporation Titan™ Ti Suture Anchor

The provided 510(k) summary for the Titan™ Ti Suture Anchor does not detail acceptance criteria and device performance in the context of diagnostic accuracy or AI performance. Instead, it focuses on establishing substantial equivalence to predicate devices through performance testing that demonstrates the physical and mechanical properties of the suture anchor are comparable.

The "performance testing" referred to in the document would typically involve mechanical tests to assess properties like pull-out strength, fatigue, and material biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity. The acceptance criteria would be defined as meeting or exceeding the performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) and corresponding device performance values are not explicitly stated in the provided text, a detailed table cannot be populated. The document only generically states:
"Additionally, performance testing has been completed to demonstrate the substantial equivalence of the Titan Ti Suture Anchor to the predicate device."
"The differences in performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device."

Therefore, the principle acceptance criterion is:

• Acceptance Criterion: The Titan Ti Suture Anchor's performance specifications (likely mechanical and material properties) must be substantially equivalent to those of the predicate devices.
• Reported Device Performance: Performance testing demonstrated substantial equivalence to predicate devices.

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

• Sample Size: Not specified in the provided text. The "performance testing" likely involved a set of physical devices subjected to mechanical tests.
• Data Provenance: Not specified. This would refer to laboratory testing data, not clinical patient data.

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

• Not Applicable. For this type of medical device (suture anchor), "ground truth" is established through engineering and material science testing standards, not through expert human interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes where discrepancies need resolution. This is not the case for mechanical performance testing of a suture anchor.

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

• Not Performed/Not Applicable. The device is a physical implant, not a diagnostic tool or AI-assisted system for interpretation. MRMC studies analyze human reader performance, usually in radiology or pathology, which is irrelevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Performed/Not Applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.

7. Type of Ground Truth Used

• Engineering and Material Science Standards: The "ground truth" for this device's performance would be defined by industry standards for mechanical properties (e.g., ASTM standards for pull-out strength, fatigue) and biocompatibility, as measured by laboratory testing. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of AI or machine learning for this physical medical device. The "training" in manufacturing involves process validation and quality control, not data-driven model training.

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

• Not Applicable. As there is no training set as understood in AI/ML, there's no ground truth established for it.

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The Parcus V-LoX™ Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

• Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
• Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
• Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
• Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
• Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.

Acetabular Labral Repair Hip

The Parcus V-LoX Titanium Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5mm and 6.5mm.

The provided document describes the Parcus V-LoX™ Titanium Suture Anchor and its substantial equivalence to predicate devices, focusing on mechanical performance rather than algorithm-based device performance. Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this documentation.

However, I can provide information based on the mechanical testing described for this medical device.

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 size used for the mechanical testing (pullout strength and insertion torque). It mentions "side by side comparisons were done with the Smith & Nephew predicate device."

• Test Set Sample Size: Not specified.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing performed by Parcus Medical, LLC. It is a prospective study in the sense that the new device was manufactured and then tested.

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

Not applicable. This device is a mechanical implant, and its performance is evaluated through physical measurements (pullout strength, insertion torque) against established engineering standards or predicate device performance, not against expert-established ground truth like in image analysis or diagnostic algorithms.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing does not involve subjective adjudication by experts. The results are objective measurements.

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 implant, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Measured physical properties: Direct measurements of pullout strength and insertion torque.
• Comparison to predicate devices: The established performance of existing, legally marketed suture anchors (e.g., Smith & Nephew Suture Anchor, Arthrex Corkscrew FT II Suture Anchor, ConMed Linvatec Bio Mini-Revo Suture Anchor) serves as the benchmark for "substantial equivalence."
• Published literature: The document states that "The published literature was reviewed," suggesting that general performance expectations for such devices were also considered.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for a mechanical medical device in the context of algorithm development.

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

Not applicable. There is no "training set" or "ground truth" in the AI/algorithm sense for this type of device.

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