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The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

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

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

Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

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 Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.

Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".

The Suture Anchors - GM Reis is composed of two different groups of anchors:

• HTA – Headless Titanium Anchor.
  • Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
• -ZIP Anchor.
  • Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.

The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.

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The Arthrex self-punching PushLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder: Shoulder: Rotator Cuff Repair

The Arthrex Self-Punching PushLock Anchor is a push-in, fully threaded barbed suture anchor comprised of a PEEK Optima eyelet and a hollow anchor body pre-assembled on a disposable inserter. The anchor body is made of either PLLA/βTCP or PEEK Optima. The Arthrex Self-Punching PushLock Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder.

The provided FDA 510(k) summary is for a medical device called the "Arthrex Self-Punching PushLock Suture Anchor". This document does not include information about AI/ML device performance or clinical studies in the context of diagnostic accuracy, which is what your questions are geared towards.

The performance data summarized in this document relates to the mechanical properties, shelf-life, MR safety, and pyrogenicity of a physical medical device (suture anchor), not the performance of an AI model. Therefore, I cannot extract the information required for your questions (acceptance criteria, study design for AI models, expert ground truth, etc.) from this document.

The document states:

• Performance Data: "Ultimate load testing and insertion testing was performed on the subject device and compared to the predicate device cleared under K101679 to demonstrate that the modifications do not negatively impact mechanical strength." It also mentions shelf-life and MR safety.

This means the acceptance criteria and study proving it, in this context, would be based on engineering and biocompatibility standards, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC as evaluated for AI models.

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

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, 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 Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tend 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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair

The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter.

The provided text describes the Arthrex Knotless SutureTak Anchor and its substantial equivalence to predicate devices, focusing on its intended use and mechanical properties. However, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software device submission.

The document primarily focuses on regulatory clearance for a physical medical device (an anchor) and relies on mechanical testing for performance. There is no mention of an algorithm, AI, or human reader performance.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: While the document mentions "established minimum acceptance criteria for tensile (pull-out) strength," it does not provide the specific criteria values or the reported performance data in a table format.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission which focuses on mechanical testing, not a "test set" in the context of an algorithm.
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 a physical anchor's mechanical performance is typically established through laboratory testing following engineering standards, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests.
8. The sample size for the training set: Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance:

The document states:

• "The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength for the desired indications."

This indicates that mechanical testing was performed, and the device's performance in terms of tensile (pull-out) strength met predefined criteria. However, the specific values for these criteria and the results are not detailed in the provided text.

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The RoG 5.5 mm Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:

• . Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
• Foot/Ankle indications: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
• t Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.

The RoG 2.9mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:

• Shoulder indications:- Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
• Wrist/hand indications:- Scapholunate ligament reconstruction. .
• . Elbow indications:- Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications:- Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure. extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.

The subject device is screw-like in shape and composed exclusively of PEEK plastic. It is available in diameters of 5.5mm and 2.9mm and lengths of 10mm and 17mm. It is supplied non-sterile and is intended for sterilization by the user facility. It allows the user to secure a suture of his/her selection to the top of the anchor. The anchor is supplied with reusable taps and guides of corresponding sizes.

The provided document is a 510(k) summary for the RoG Suture Anchor, a medical device. It describes the device's technical specifications, intended use, and its equivalence to predicate devices, but it does not contain information about a study involving AI, human readers, or image analysis.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on design considerations, materials, performance characteristics (mechanical testing), and indications for use. It typically does not involve the kind of clinical or comparative effectiveness studies with human readers or AI that your request outlines.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human readers, or ground truth establishment in the way you described, because the provided document does not pertain to such a device or study.

The "Performance Characteristics" section explicitly states: "Both sizes of subject were evaluated in accordance with FDA's Guidance Document for Testing Bone Anchor Devices (4/20/96). Testing consisted of tapping and pull testing with comparison to the corresponding size of predicate devices. The subject device was found to be equivalent to the corresponding sizes of the predicate devices in such testing." This indicates the evaluation was purely mechanical and comparative to existing similar devices.

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The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial 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 SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.

The provided 510(k) summary (K101823) describes the Arthrex SwiveLock Anchors, a medical device intended for fixing suture (soft tissue) to bone in various anatomical regions. The device is seeking substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the Arthrex SwiveLock Anchors are based on demonstrating substantial equivalence to existing predicate devices. Since this is an equivalence submission, specific quantitative acceptance criteria for absolute performance metrics are not explicitly stated in the summary. Instead, the performance is compared against the known performance of the predicate devices.

The study aimed to demonstrate that the SwiveLock Anchors perform comparably to the predicate devices in terms of:

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

The document does not explicitly state the specific sample sizes for each test mentioned (degradation, mechanical pull-out, insertion, animal testing). It only refers to "data" for each category.

The data provenance is not specified. It is an industry standard to conduct these tests in a controlled laboratory environment or animal models. Neither the country of origin nor whether the data is retrospective or prospective is mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this type of 510(k) submission. Establishing "ground truth" by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is involved. For a mechanical device like a suture anchor, the "truth" is established through physical and biological testing against established standards or predicate device performance.

4. Adjudication Method:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts in diagnostic studies, which is not relevant for the mechanical and biological testing of a suture anchor.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is evaluated.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through physical and biological testing methodologies. This includes:

• Degradation data: Measuring the breakdown of biomaterials over time.
• Mechanical pull-out (tensile) testing data: Quantifying the force required to pull the anchor out of bone, adhering to engineering standards.
• Insertion testing data: Assessing the ease and characteristics of device insertion.
• Animal testing data: Observing the biological response (histology), in-vivo pull-out strength, and imaging of the device in a living system.

The "truth" is rooted in the physical and biological properties and performance of the device as measured by these tests, compared against the known performance of predicate devices.

8. Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Arthrex SwiveLock Anchor is a mechanical device, not an AI or algorithm-driven system.

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

This information is not applicable for the reasons stated above.

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The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in sufure anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylene suture. The Bio Mini-Revo suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions: with or without colorant D&C violet #2.

This document is a 510(k) summary for the ConMed Linvatec Bio Mini-Revo Suture Anchor. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a new, unique device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted because such a study is not described in this 510(k) submission.

Key points from the document that explain why the requested information isn't available:

• Type of Submission: This is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with defined acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The ConMed Linvatec Bio Mini-Revo Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K053561, K072291 and K061863."
• Lack of Performance Data: There are no sections detailing specific performance metrics, clinical study results, or statistical analyses against defined acceptance criteria that would typically be found in a study proving a device meets certain performance thresholds.
• Device Type: The device is a Bioabsorbable Suture Anchor. The 510(k) generally relies on the established safety and performance of similar predicate devices and material characterization (e.g., bioabsorption properties of the PLA Copolymer) rather than a comparative study of its clinical performance against specific metrics.

In summary, this 510(k) submission successfully established substantial equivalence, allowing the device to be marketed, but does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance) that would be provided for a device with a novel mechanism requiring such demonstration.

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Shoulder: Rotor 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; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair and secondary fixation in ACL / PCL reconstruction repair. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

The Healix Ti Anchor is a non-absorbable threaded suture anchor manufactured of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through The Healix Anchors are currently offered with absorbable tissue. Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

The provided text is a 510(k) summary for the Healix Ti Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or performance testing that would generate the kind of data requested in your prompt. This type of submission relies on comparisons to already approved devices.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size, ground truth, MRMC study, training set information) are not applicable or available within this document.

Here's an assessment based on the provided text:

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

• Not applicable / Not provided. The 510(k) summary states, "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." It does not list specific acceptance criteria (e.g., pull-out strength, fatigue life) or provide quantitative performance data for such criteria directly within this document. The "tests" performed are implicit in demonstrating substantial equivalence, likely through mechanical bench testing, but the details are not given here.

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

• Not applicable / Not provided. No specific 'test set' in the context of clinical or performance data is described in this summary. The substantial equivalence argument relies on comparison to predicate devices and likely bench testing, not a clinical test set.

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)

• Not applicable / Not provided. Ground truth, in the context of expert consensus or clinical outcomes, is not relevant to this 510(k) submission, which is for a mechanical bone anchor and focused on substantial equivalence to existing devices.

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

• Not applicable / Not provided. Adjudication methods are typically for clinical studies or image interpretation, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a mechanical bone anchor, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

• Not applicable. This device is a mechanical bone anchor, not an algorithm.

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

• Not applicable / Not provided. Ground truth in the sense of clinical outcomes or expert labels is not part of this 510(k) summary for a mechanical device. The "ground truth" for substantial equivalence for such a device is typically established through a combination of engineering analysis, material properties testing, and mechanical performance tests (e.g., pull-out strength, fatigue) compared against the predicate devices. These specific tests and their "ground truth" values (e.g., meeting a certain strength threshold) are not detailed in this high-level summary.

8. The sample size for the training set

• Not applicable. This document describes a mechanical medical device, not a machine learning model, so there is no 'training set'.

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

• Not applicable. As above, there is no training set for this type of device.

Summary based on the document:

The provided document is a 510(k) summary for the Healix Ti Anchor. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present performance data against specific acceptance criteria from a primary clinical study. The "study that proves the device meets the acceptance criteria" is implicitly the "performance and safety testing" mentioned, but the details of these tests, specific criteria, and quantitative results are not included in this summary. Such details would typically be found in the comprehensive 510(k) submission itself, but not in this summary section.

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Healix Anchor is indicated for use in the following: Shoulder: Rotor 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: Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

The Healix Anchor is a non-absorbable threaded suture anchor manufactured of polyetheretherketone (PEEK) material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

Here's an analysis of the provided text regarding the Healix Anchor, focusing on acceptance criteria and supporting studies:

Based on the provided document, the Healix Anchor is a medical device, and the submission is a 510(k) premarket notification. This type of submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, quantitative acceptance criteria through a clinical study.

Therefore, the information you've requested about acceptance criteria and supporting studies, particularly those involving human readers, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, is not present and not applicable in this context. The document focuses on demonstrating substantial equivalence through technological characteristics and existing performance and safety testing.

Here's a breakdown of what can be extracted from the document in relation to your questions, and where information is inherently missing due to the nature of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Missing Information (Not applicable or not typically found in this type of 510(k) summary for a physical medical device)

1. Sample size used for the test set and the data provenance: This device is a physical bone anchor, not an AI or diagnostic imaging device that uses "test sets" of data as understood in that context. The "testing" referred to is likely mechanical, biocompatibility, and sterilization testing, not performance on data sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, refers to expert-validated data. For a physical implant, "ground truth" might relate to mechanical strength or biocompatibility standards, and would be established through engineering and biological testing, not expert consensus on images or outcomes.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 implant, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As stated above, "ground truth" for a physical device would relate to engineering specifications and biocompatibility standards. The document implicitly states that "performance and safety testing" was conducted, but doesn't detail the specific methodologies or "ground truths" used beyond establishing substantial equivalence to predicates.
7. The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires training data.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves Acceptance:

The "study" referenced in this 510(k) summary is not a single clinical trial or a data-driven performance study in the way one might think of for an AI diagnostic device. Instead, it refers to a submission demonstrating substantial equivalence to previously legally marketed devices (the predicate devices: Mitek Spiralok Anchor, Arthrex Corkscrew FT Anchor, and Arthrex Biocorkscrew Anchor).

The proof of acceptance rests on the assertion that:

• The indications for use of the Healix Anchor are clearly defined and substantially similar to the predicate devices.
• The technological characteristics (materials, design, sizes, suture options) are similar enough to the predicate devices that they do not raise new questions of safety or effectiveness.
• Performance and safety testing (not detailed in this summary, but typical for these devices includes mechanical strength, fatigue, biocompatibility, and sterilization validation) has been conducted and demonstrates that the device is substantially equivalent to the predicate devices.

The FDA's decision to clear the device (as indicated in the letter from Mark N. Melkerson) signifies their agreement that the device has met the criteria for substantial equivalence under 21 CFR 888.3040, thereby allowing it to be marketed.

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