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The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Superior Capsule Reconstruction (Glenoid Only)
Hip: Acetabular Labral Repair
Knee: MCL, LCL, Iliotibial Band Tenodesis
Foot/Ankle: Lateral Stabilization, Medial Stabilization

The proposed GRYPHON™ Flex Knotless PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed GRYPHON Anchor family. The proposed product is a knotless anchor intended for fixation of soft tissue to bone in various soft tissue repair procedures. In its finished good configuration, the proposed device is a two-piece design; comprised of a permanent implant (anchor) component and a disposable (inserter) component. The 2.7mm anchor implant is preloaded on the inserter and a Nitinol distal tip retains the suture and the anchor while the device is malleted into the bone. The design offers surgeons maneuverability within the joint space. The disposable inserter will be offered in two design configurations, straight or curved to accommodate varying anatomies.
The proposed GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors will be available in a 2.7 mm size, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.
Both the GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "GRYPHON™ Flex Knotless PEEK Anchor" and "GRYPHON™ Flex Knotless Biocomposite Anchor."

This document does not describe a study that uses AI or machine learning. It describes the non-clinical verification activities performed for a physical medical device (suture anchor), focusing on its mechanical properties, sterilization, and biocompatibility. Therefore, it does not include the information requested regarding acceptance criteria and studies for AI/ML device performance, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details.

The acceptance criteria mentioned in the document relate to the physical and biological performance of the anchor, not to the performance of a diagnostic or predictive algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria based on the provided text, as the text describes a physical medical device, not an AI/ML system.

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ACTIVBRAID™ is indicated for use in soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.

ACTIVBRAID is a partially absorbable surgical co-braid suture constructed of nonabsorbable Ultra High Molecular Weight Polyethylene (UHMWPE) and absorbable bovine-derived type I collagen. ACTIVBRAID suture ends are stiffened with cyanoacrylate.

ACTIVBRAID is available in several sizes (sutures meet U.S. Pharmacopeia standards for nonabsorbable sutures, except diameter). Sutures are oversized in diameter. ACTIVBRAID is provided in pre-cut lengths with and without needles. Suture strands that are dyed (Chromium Cobalt-Aluminum Oxide or D&C Black No. 4) are made of UHMWPE.

The provided text is a 510(k) Summary for the ACTIVBRAID™ surgical suture. It details the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence. However, the document does not describe a study involving a medical device software with AI/ML components that would have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance.

The "performance data" section in the document refers to:

• Biocompatibility Testing: Evaluating the biological response of the material.
• Non-Clinical Performance Testing: Assessing physical properties of the suture (diameter, needle attachment, tensile strength) against USP standards and comparing other mechanical properties (abrasion, knot profile/security, physiological fluid absorption) to the predicate device.
• Resorption Profile: Characterizing the device's absorption rate and tensile strength retention over time in an animal model.

These are standard performance tests for physical medical devices like sutures, not for AI/ML-driven diagnostic or assistive software. Therefore, the requested information about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

The document explicitly states: "Biocompatibility and nonclinical performance testing data demonstrate that ACTIVBRAID is as safe, as effective, and performs as well as or better than the predicate device, K112899." This indicates that the "acceptance criteria" are related to meeting or exceeding the performance of the predicate device and established standards for surgical sutures.

In summary, the provided text does not contain the information requested about AI/ML device acceptance criteria and studies.

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DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.

DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™ Suture has a double sheath and core design, and contains Ultra High Molecular Weight Polyethylene, Polyester and a Silicone/NaCl core.

The provided text describes a 510(k) premarket notification for the DYNACORD™ Suture, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met for an AI device.

The document is for a non-AI medical device (surgical suture) and therefore does not discuss AI-specific metrics like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC comparative effectiveness studies (which are relevant to AI's impact on human readers).

However, I can extract the information that is present regarding the non-clinical testing performed for this suture, which serves as its performance and safety evaluation.

Here's the information I can provide based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Performance testing included: USP Diameter (DYNACORD™ is oversized), USP Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility, sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits."

The conclusion is: "Results of non-clinical testing have demonstrated that the proposed devices are suitable for their intended use."

Regarding AI-specific questions:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
• 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 an AI algorithm is not established for this device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or reference standards would be established by the standardized methods for each test (e.g., USP monographs for suture properties, recognized biocompatibility standards, sterility testing protocols, in-vivo animal model observations for efficacy and safety).
• 8. The sample size for the training set: Not applicable. This is not an AI device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder Rotator Cuff Biceps Tenodesis

The proposed HEALIX ADVANCE KNOTLESS BR ANCHOR is a cannulated, threaded knotless anchor designed to secure soft tissue to bone. The proposed anchor is manufactured from the absorbable material "Biocryl® Rapide™" (15/85% B - TCP/PLA PGA copolymer) loaded on a disposable inserter driver with #2 ORTHOCORD® suture (K040004, K043928). The anchors are offered in two sizes (4.75 mm and 5.5 mm).

The provided text is a 510(k) summary for a medical device (HEALIX ADVANCE KNOTLESS BR ANCHOR) and does not contain the detailed information necessary to answer all aspects of your request. Specifically, it lacks a dedicated "acceptance criteria" section and a detailed study report.

However, based on the Safety and Performance section, we can infer some aspects related to device performance and the type of study conducted to support substantial equivalence.

Here's an attempt to answer your questions based on the available information, with clear indications where information is missing:

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

The document mentions "Performance requirement of the proposed device is to secure soft tissue to bone during soft tissue healing period." It then states that "Fixation force testing was performed under in vitro condition throughout two times of healing period." The conclusion is that "The data shows that the proposed device performs similarly to the predicate devices."

Therefore, the implicit acceptance criteria would be for the device's fixation force to be "similar to the predicate devices" during and after the specified healing period. The reported performance is that it "performs similarly to the predicate devices."

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

This information is not provided in the document. The document only mentions "in vitro condition" for the fixation force testing.

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/provided. The study described is an in vitro performance test, not a clinical study involving human or animal data that would require expert-established ground truth.

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

This information is not applicable/provided. The study described is an in vitro performance test.

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

This information is not applicable. The device is a bone anchor, not an AI-powered diagnostic tool, and therefore no MRMC study involving human readers and AI assistance would be conducted for its clearance.

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

This information is not applicable. The device is a bone anchor, not an algorithm. The "standalone" performance here would refer to the mechanical performance of the anchor itself, which was evaluated as described.

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

For the "fixation force testing," the "ground truth" would be the measured mechanical properties (e.g., maximum load to failure, displacement, stiffness) of the device and its predicate, obtained through controlled engineering tests. For "material biocompatibility," the ground truth would be established through standard biocompatibility testing as per ISO or ASTM standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an algorithm that requires a "training set."

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

This information is not applicable.

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The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular repair, acetabular labral repair.

The Gryphon PEEK Anchors are non-absorbable threaded suture anchors manufactured of PEEK material. The barbed anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Gryphon PEEK Anchor is provided as size 3.0mm. The Gryphon PEEK Anchors will be offered with partially absorbable Orthocord suture options, similar to the Gryphon P BR Anchor. Technologies characteristics including design and packaging are the same as the predicate cleared devices.

The provided text is a 510(k) summary for a medical device called the "Gryphon PEEK Anchor." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the information you've requested regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods for a new study is not present in this document.

The study described here is primarily a comparative assessment to existing, legally marketed devices (predicates) to establish substantial equivalence.

Here's what can be extracted from the document in relation to your questions, and what cannot:

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

• Not explicitly provided as a table with specific quantitative acceptance criteria or a detailed breakdown of reported performance values.
• The document states: "Non clinical Testing Verification activities were performed on the implant or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility. Safety and Performance Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."
• This indicates that mechanical performance (pull-out strength) and other safety aspects were tested, and the results were found to be comparable to existing devices, satisfying the "substantial equivalence" criteria for regulatory approval. However, no numerical values or specific thresholds are given.

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

• Not specified. The document mentions "pull out testing" but does not give sample sizes, origin of data, or details on whether the testing was conducted on clinical samples or benchtop models.

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 specified. This scenario is for a mechanical device; "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. Device performance is determined by engineering tests (e.g., measuring pull-out force).

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

• Not applicable/Not specified. See point 3.

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

• Not applicable. This device is a surgical anchor, not an AI or imaging diagnostic tool. An MRMC study would not be relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Mechanical testing results. The "ground truth" for a device like this would be derived from objective engineering measurements (e.g., the force at which the anchor pulls out of bone substitute).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. There is no concept of a "training set."

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

• Not applicable. See point 8.

In summary:

The document describes a 510(k) submission for a non-absorbable threaded suture anchor. The "study" mentioned is focused on "Non clinical Testing Verification activities... includ[ing] pull out testing, shelf-life, sterilization and biocompatibility." The primary conclusion drawn from these activities is that the device is "substantially equivalent to predicate devices." This type of regulatory submission does not typically involve the detailed breakdown of performance metrics, sample sizes, and ground truth establishment methods that would be seen in an AI or diagnostic study.

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CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.

CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.

The provided document is a 510(k) summary for a medical device (CP-Fiber suture). While it describes the device's intended use and substantial equivalence to predicate devices, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

This document focuses on regulatory approval based on demonstrating equivalence to existing products rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document states: "Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures." This is a general statement about compliance with a standard, but it doesn't provide the detailed acceptance criteria or study results that you're asking for.

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The RC Loop Anchor with Dual Orthocord Suture is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Rotator cuff repair

RC Loop with Dual Suture is a preloaded, absorbable disposable suture anchor/ inserter assembly for rotator cuff repair. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Panalok RC Loop Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The information provided describes a 510(k) premarket notification for a medical device and not a study assessing device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and reader studies is not present in the provided text.

However, I can extract the relevant information regarding the type of assessment performed for this medical device:

Device: RC Loop Anchor with Dual Orthocord Suture

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not applicable. The "test set" in this context refers to physical bench testing, not a dataset of medical images or patient records. This was a bench test, and not a clinical study.

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

• Number of Experts: Not applicable. Ground truth for bench testing is established by technical specifications and validated testing methodologies, not expert consensus in a clinical diagnostic sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Bench testing results are typically evaluated against predefined engineering and material standards.

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

• MRMC Study: No. This is a physical medical device (suture anchor), not an AI/ML diagnostic tool.

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

• Standalone Performance: Not applicable. This is a physical medical device.

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

• Type of Ground Truth: Engineering specifications, material standards (e.g., USP monograph), and predefined technical criteria for suture compatibility and deployment.

8. The sample size for the training set:

• Sample Size: Not applicable. This refers to a physical medical device, not an AI/ML algorithm.

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

• How Ground Truth Was Established: Not applicable.

Summary of the Study:

The provided text describes a 510(k) Premarket Notification for a medical device. The "study" mentioned is a series of bench tests conducted to demonstrate that the RC Loop Anchor with Dual Orthocord Suture is "substantially equivalent" to a predicate device.

• Study Type: Bench testing (not a clinical trial, diagnostic accuracy study, or AI/ML performance study).
• Purpose: To demonstrate conformance to consensus and voluntary standards, and that the device performs as intended in terms of material properties (suture conformance to USP monograph) and functional aspects (suture compatibility and deployment).
• Conclusion: Based on the bench testing, device description, and comparison to predicate devices, the manufacturer concluded that the device is substantially equivalent to predicate devices.

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The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Super Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Super Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The provided text describes the "Super Quickanchor Plus" device and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This document is a premarket notification for a medical device and therefore does not contain the kind of detailed study information (e.g., acceptance criteria, test set sample sizes, expert qualifications, HR/AI performance improvement, training set details) associated with demonstrating the performance of a device against specific acceptance criteria.

The document primarily states that the determination of substantial equivalence was based on:

• Detailed device description
• Conformance to consensus and voluntary standards
• Bench testing: This bench testing "demonstrated that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria."

Therefore, it's impossible to fill out most of the requested table and answer the study-specific questions based on the provided text. The text confirms that some acceptance criteria related to suture conformity, compatibility, and deployment were met through bench testing, but it does not specify what those criteria were or the details of the study.

Here's what can be extracted and what cannot:

1. A 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.
• Data Provenance: Not specified, but generally, bench testing for 510(k) submissions would be laboratory-based rather than patient 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)

• Not applicable. This was bench testing, not a clinical study involving expert interpretations of data.

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

• Not applicable. This was bench 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

• Not applicable. This is a medical device (surgical anchor), not an AI diagnostic or interpretive tool.

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

• Not applicable. This is a medical device (surgical anchor).

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

• For the bench testing described, the "ground truth" would be objective measurements and adherence to technical specifications and standards (e.g., USP monograph specifications, engineering performance metrics for deployment forces, mechanical integrity).

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI/machine learning model that undergoes "training."

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

• Not applicable.

Summary of what the document does communicate regarding device performance:

The document states that the Super Quickanchor Plus (with ORTHOCORD) was found to be substantially equivalent to its predicate device (Super Quickanchor Plus, K041116). This determination was supported by bench testing that confirmed:

• The ORTHOCORD suture conformed to the USP monograph for absorbable sutures.
• The suture compatibility and deployment met predetermined acceptance criteria.

These statements confirm that certain performance standards were met, but the specific numerical values of the acceptance criteria and the detailed results of the bench testing are not included in this 510(k) summary.

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Output:
The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

Rotator Cuff Quickanchor Plus (with ORTHOCORD) is a preloaded metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Rotator Cuff Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture dimensions. (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The provided text is a 510(k) summary for the "Rotator Cuff Quickanchor Plus" device. It describes a suture anchor system used for rotator cuff repair. However, it does not include a study that proves the device meets specific acceptance criteria in the way described in your request (i.e., with reported device performance alongside acceptance criteria, detailed sample sizes, expert involvement, etc.).

Instead, the document states:

"The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria."

This indicates that some bench testing was done against "predetermined acceptance criteria" for suture compatibility and deployment, and that the ORTHOCORD suture conformed to a USP monograph. However, the document does not provide the specific acceptance criteria themselves, nor does it detail the results of this bench testing beyond a general statement of conformance.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or provide details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text.

The document primarily focuses on establishing substantial equivalence to a predicate device (Rotator Cuff Quickanchor Plus, K992611) manufactured by the same company, based on design, configuration, and intended use, rather than presenting a performance study with detailed acceptance criteria and results.

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The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.

Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

GII Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the GII Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The GII Quickanchor Plus is a medical device designed for soft tissue repair to bone using a preloaded, metallic disposable suture anchor/inserter assembly. The following details the acceptance criteria and the study that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a distinct "test set" for the GII Quickanchor Plus separate from the general bench testing. The evaluation was based on conformance to consensus and voluntary standards and bench testing. Therefore, details regarding sample size for a specific test set, country of origin, or retrospective/prospective nature of the data are not provided.

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

This information is not provided in the document. The evaluation relies on "conformance to consensus and voluntary standards" and "bench testing" rather than expert-established ground truth on case data.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (bench testing for material conformance and system deployment), an adjudication method as typically applied to clinical or imaging datasets is not applicable or described.

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

No MRMC comparative effectiveness study is mentioned. The submission is for a medical device (suture anchor), not an AI diagnostic tool that would typically involve human reader performance evaluation.

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

This is not applicable as the GII Quickanchor Plus is a physical medical device, not an algorithm or AI system. The "standalone" performance refers to the device's ability to meet its functional specifications during bench testing. The bench testing demonstrated that the Orthocord suture, suture compatibility, and deployment met predetermined acceptance criteria.

7. Type of Ground Truth Used

The ground truth used was based on:

• USP monograph for absorbable sutures: This serves as a standardized, objective benchmark for material properties.
• Predetermined acceptance criteria for suture compatibility and deployment: These are internal engineering specifications established to ensure the device functions as intended.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI model that requires a training set of data.

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

This information is not applicable, as there is no training set mentioned for this device.

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