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VERSALOCK Anchor is indicated for use in the following: Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

The Versalok Peek Anchor System includes the Versalok Peek Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system is provided with and without a Orthocord#2 suture.

Here's the breakdown of the acceptance criteria and study information for the Versalok Peek Anchor, based on the provided 510(k) summary:

This device is a bone anchor, not an AI/software device. Therefore, many of the typical AI-related study components (like expert ground truth, MRMC studies, training sets, etc.) are not applicable in this context. The "acceptance criteria" here refers to the performance standards demonstrably met by the device to prove substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of anchors, test specimens) used for the nonclinical testing (pull-out, shelf life, sterilization, biocompatibility).
• Data Provenance: The data is generated from nonclinical testing of the device or its predicates. The country of origin for the data is not specified but is implicitly associated with the manufacturer (DePuy Mitek, Inc. in Raynham, MA, USA). The testing is prospective for the Versalok Peek Anchor to demonstrate its performance against established standards and predicate devices.

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

• Not Applicable: For a physical medical device like a bone anchor, "ground truth" in the context of expert consensus (as used for imaging or diagnostic AI) is not relevant. The ground truth for mechanical and material properties is established by validated engineering and scientific testing standards and methodologies.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication is typically associated with human reviewer discrepancies (e.g., in medical image interpretation). For nonclinical testing of a physical device, the "adjudication" is inherent in the objective nature of the test results themselves against predefined pass/fail criteria or comparison to predicate performance.

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 an AI/software-specific study type. The Versalok Peek Anchor is a physical implantable medical device, not an AI or software product.

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

• Not Applicable: This is an AI/software-specific study type. The Versalok Peek Anchor is a physical implantable medical device.

7. The Type of Ground Truth Used:

• For the nonclinical studies, the "ground truth" is based on:
  • Objective physical measurements and chemical analyses according to recognized standards (e.g., ASTM, ISO standards for pull-out strength, material characterization, biocompatibility testing guidelines).
  • Performance of legally marketed predicate devices (Trident Anchor, Versalok Ti Anchor, Arthrex Pushlock Anchor) as benchmarks for substantial equivalence.

8. The Sample Size for the Training Set:

• Not Applicable: This is an AI/software-specific concept. There is no "training set" for a physical medical device.

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

• Not Applicable: As above, there is no "training set."

Summary of the Study Proving Acceptance Criteria:

The study proving the Versalok Peek Anchor meets acceptance criteria is a series of nonclinical performance and safety tests. These tests were conducted on the implant or its predicates and included:

• Pull Out Testing: To evaluate the mechanical strength and fixation capability of the anchor.
• Shelf Life Testing: To ensure the device maintains its properties over its intended storage duration.
• Sterilization Testing: To confirm the effectiveness of the sterilization process and ensure the device remains sterile until use.
• Biocompatibility Testing: To assess the biological safety of the materials in contact with body tissues.

The document states that the "results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This substantial equivalence, based on these verified tests and comparison to the predicate devices (Trident Anchor, Versalok Ti Anchor, and Arthrex Pushlock Anchor), forms the basis for the FDA's clearance. The "acceptance criteria" are implicitly met by confirming these performance and safety characteristics are comparable or equivalent to the already cleared predicate devices.

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Micro QuickAnchor Plus (Micro QA+ Anchor): The Micro QuickAnchor Plus is indicated for fixation of non-absorbable braided polyester or partially absorbable braided composite surgical suture to bone. This product is intended for the indications listed below: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Lateral canthoplasty.

Microfix QuickAnchor Plus (Microfix QA+ Anchor): The Microfix QuickAnchor Plus is indicated for fixationof soft tissue to bone, using suture for the in dications listed below. Hand: Hand: Repair / reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalaangeal), DIP ( distal interphalaaangeal), and MCP (metacarpal interphalangeal) joints for all digits. Skull: Soft tissue attached to the parietal. Temporal ridge, frontal, mandible, maxilla, zygoma, and periobital bones of the skull.

Micro QA + with #3-0 Orthocord or #4-0 Orthocord / Microfix QA+ with #3-0 Orthocord or #4-0 Orthocord are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the hand and skull. The anchor is dimensionally identical anchor to that of the Micro QA+ Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord / Microfix QA+ Anchor with Ethibond #3-0 Orthocord or 4-0 Orthocord.

The provided text describes a 510(k) summary for a medical device, the Micro QA+ Anchor / Microfix QA+ Anchor. It details the device's description, indications for use, and a statement about safety and performance. However, it does not contain the specific information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study using a test set with details like sample size, ground truth, expert qualifications, or adjudication methods.

The relevant section in the document states:

"Bench testing was performed demonstrating that the Micro QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with #3-0 and #4-0 Orthocord met predetermined acceptance criteria."

This confirms that bench testing was done and met predetermined acceptance criteria, but it does not specify what those criteria were or what the performance results were in detail. It also doesn't mention a study designed to evaluate performance using a test set in the way a clinical or AI-based study would.

Therefore, for most of your requested points, the information is not available in the provided text.

Here is what can be inferred or explicitly stated from the provided text, and what cannot:

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

Reasoning: The document states "Bench testing was performed demonstrating that the Micro QA+ Anchor with #3-0 and #4-0 Orthocord / Microfix QA+ Anchor with #3-0 and #4-0 Orthocord met predetermined acceptance criteria." However, it does not provide the specific criteria (e.g., tensile strength, pull-out force thresholds) or the quantitative results of the tests.

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 for Test Set: Not specified. The document mentions "bench testing" but does not give sample sizes or details about the number of anchors or tests performed.
• Data Provenance: Not applicable. This was bench testing, not a study involving human data or clinical outcomes.

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)

• Number of Experts: Not applicable. Ground truth as typically defined in clinical or AI studies (e.g., expert consensus on images or pathology) is not relevant for bench testing of a medical device's physical properties.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. As this was bench testing for physical properties, an adjudication method for interpreting results is not mentioned or typically used in the same way as in clinical image review.

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 Done: No. This document describes a physical medical device (suture anchors), not an AI algorithm or diagnostic tool. A MRMC study is not relevant.
• Effect Size: Not applicable.

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

• Standalone Performance Test: No. This document describes a physical medical device and its bench testing, not an algorithm.

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

• Type of Ground Truth: For the "bench testing," the "ground truth" would be the engineering specifications and established test methods used to determine performance (e.g., material strength standards, mechanical testing protocols). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable. This document describes a physical medical device, not a machine learning model.

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VERSALOK Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

The Versalok Anchor System includes the Versalok Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system could be provided with a variety of #2 suture options.

This 510(k) summary for the Versalok Anchor does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document is a standard 510(k) submission summary, primarily focused on establishing substantial equivalence to predicate devices. It discusses:

• Submitter and Contact Information: DePuy Mitek, Ruth C. Forstadt.
• Device Name: Versalok Anchor.
• Classification: Orthopedic fasteners (Smooth or threaded metallic bone fixation fastener).
• Substantial Equivalence: States it is substantially equivalent to the Trident Anchor (K060914).
• Device Description: Describes the anchor, inserter, threader tab, suture, and deployment gun.
• Indications for Use: Lists specific applications in the shoulder, knee, and elbow.
• Safety and Performance: Simply states that "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.

The document focuses on regulatory classification and substantial equivalence, not on a detailed performance study with quantifiable acceptance criteria. For medical devices, "performance testing" in the context of a 510(k) often refers to bench testing (e.g., mechanical strength, pull-out strength) to demonstrate that the new device performs similarly to or better than the predicate device under simulated conditions, rather than a clinical study with human patients. However, the exact details of such testing, including acceptance criteria and results, are not included in this summary.

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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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Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

Blue ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a medical device (Blue ORTHOCORD suture) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or reporting detailed performance metrics against those criteria in the format typically found for diagnostic or interventional devices with quantifiable outcomes like accuracy, sensitivity, or specificity.

For medical sutures, "acceptance criteria" and "device performance" are typically evaluated against established consensus standards and the USP monograph for absorbable sutures. The document states:

2. Sample Size and Data Provenance

The document describes non-clinical laboratory testing. For such testing, the concept of "test set" in the context of diagnostic AI models is not directly applicable. The "sample size" would refer to the number of sutures tested for various properties (e.g., tensile strength, knot security, degradation profile). However, the specific sample sizes used for the non-clinical laboratory testing are not provided in this 510(k) summary.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as these distinctions are more relevant for clinical studies with human subjects or real-world data collection. The testing was "non-clinical laboratory testing."

3. Number of Experts and Qualifications for Ground Truth

This document does not involve the establishment of "ground truth" by human experts in the way an AI diagnostic study would. The performance of a suture is determined through objective, standardized laboratory tests (e.g., against USP monographs). Therefore, there were no experts used to establish ground truth in this context. The "ground truth" is defined by the technical specifications of the materials and the performance parameters set by regulatory and industry standards.

4. Adjudication Method

Since no human experts were involved in establishing ground truth, there was no adjudication method used.

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

No MRMC comparative effectiveness study was done. This type of study is typically conducted for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. A suture is a physical medical device, not an interpretive one.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study (algorithm only) was done. The device is a physical suture, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is based on objective measurements derived from non-clinical laboratory testing against established specifications and standards, specifically the USP monograph for absorbable sutures. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI product would be.

8. Sample Size for Training Set

There is no concept of a "training set" for this device. A training set is used to train machine learning models. This is a physical medical device, not an AI or software algorithm.

9. How Ground Truth for Training Set Was Established

As there is no training set, this question is not applicable.

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Passing Needle with ETHIBOND, PANACRYL or ORTHCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.

The provided document is a 510(k) Pre-market Notification for a medical device: "Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document explicitly states:

• "Substantial Equivalence: PANACRYL sutures have been cleared by FDA - K964345; ETHIBOND sutures have been approved by FDA - NDA 17-804 & 17-809; ORTHOCORD sutures have been cleared by FDA- K040004"
• "Safety: These sutures have been cleared through K964345 (PANACRYL), NDA 17-804 & 17-809 (ETHIBOND) and K040004 (ORTHOCORD). Safety data may be referenced in these documents."

This indicates that the current submission relies on the safety and effectiveness data of the predicate sutures themselves, and not a new study on the "Passing Needle" device that would establish new performance criteria. The "Passing Needle" likely refers to the delivery mechanism for these pre-existing sutures.

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Passing Needle with PANACRYL, ETHIBOND, or ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Mitek Passing Needle with ETHIBOND Loop is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with two colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.

Mitek Passing Needle with ETHIBOND Loop is a utility suture and needle assembly that is used in vivo for suture passage of operative suture through soft tissue during the surgical procedure. It is packaged with a colored clip and is designed to be used with the Mitek Suture Passer.

The provided text is a 510(k) summary for a medical device (Passing Needle with various sutures) that seeks to demonstrate substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.

Instead, the document primarily focuses on:

• Device Classification and Description: Details about the sutures used and the intended use of the passing needle assemblies.
• Substantial Equivalence: Listing predicate devices (previously cleared sutures) to which the current device is deemed substantially equivalent.
• Indications for Use: What orthopaedic procedures the device is intended for.
• Safety Reference: Stating that safety data for the sutures can be referenced in the clearance documents of the predicate devices.

Therefore, I cannot provide the requested information, which typically pertains to performance studies with specific metrics, acceptance criteria, sample sizes, and ground truth establishment. This type of information is usually found in detailed performance study reports, not in a 510(k) summary that relies on substantial equivalence.

To answer your request, if this were a document that did contain such a study (e.g., a clinical trial report or a comprehensive bench testing report), the table and other details would look something like this (hypothetical example, as the provided text doesn't support it):

(Hypothetical Example Based on a Fictional Performance Study)

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

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