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ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or 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.

The provided text does not contain a study or detailed performance data that would allow for a complete answer to your request. The document is a 510(k) summary for a medical device (Small Size Orthocord® Suture) seeking substantial equivalence to previously cleared devices.

Instead of a detailed study with acceptance criteria and performance metrics, it states that:

• "The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards."
• "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures, except for oversized diameter."

This indicates that the device's equivalence and safety/performance were established primarily through comparison to existing predicate devices and adherence to general standards, rather than a novel clinical or non-clinical study with specific acceptance criteria and reported device performance as you've requested for AI/software-based devices.

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text.

However, I can extract the following limited information:

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

2. Sample sized used for the test set and the data provenance: Not applicable. No specific "test set" or data provenance (country of origin, retrospective/prospective) is described for a study in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not mentioned for this type of submission.

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 device is a surgical suture, not an AI/imaging diagnostic tool.

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 concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical and mechanical properties conforming to established standards and predicate device performance, not clinical ground truth in the AI sense.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: 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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The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder (Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis), Elbow (Lateral Epicondylitis Repair), Wrist (Scapholunate Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).

The proposed TransTend Anchors are suture anchors offered in three different materials, namely Biocryl Rapide, Titanium or Peek. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The TransTend Anchors are provided as size 3.4 mm in Biocryl Rapide, 3.4mm in Peek and 2.9 mm in Titanium. Each TransTend Anchor is provided sterile and is for single patient use only. The TranTend anchors will also be offered in a convenience kit and be packaged with a cannula assembly along with one or two TransTend Anchor(s).

The provided 510(k) summary for the TransTend Anchors does not include explicit acceptance criteria with numerical thresholds, nor a specific study demonstrating compliance to such criteria in the manner typically seen for diagnostic AI/ML devices.

Instead, this submission is for a medical device (surgical suture anchors) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicates and general safety and performance standards for such devices.

Here's an breakdown based on the information provided, framed as closely as possible to your request, but acknowledging the difference in device type:

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

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

The document does not specify the sample sizes for the mechanical, biocompatibility, or sterilization tests. It describes "Verification activities" and "Testing," but no detailed protocols or sample numbers are provided for these non-clinical tests.

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

This question is not applicable to the type of device and testing described. The "ground truth" for a bone anchor is its physical and biological performance, which is assessed through engineering and biological tests, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies where expert consensus is needed. For mechanical and biological testing of a physical device, the "truth" is determined by the objective measurements of the tests themselves, against established standards or 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

This question is not applicable. MRMC studies are specific to diagnostic AI/ML devices where human readers interpret cases, and the AI's impact on their performance is evaluated. This submission is for a surgical implant (bone anchor), not a diagnostic AI tool.

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

This question is not applicable. The TransTend Anchors are a physical surgical device, not an algorithm, so there is no "standalone" algorithm performance to assess.

7. The type of ground truth used

For this device, the "ground truth" is established through:

• Engineering Test Results: Objective measurements from mechanical tests (pull-out strength, insertion torque) compared against functional requirements and predicate device performance.
• Biological Test Results: Objective measurements from biocompatibility tests, following established standards (e.g., ISO 10993).
• Sterilization Validation: Objective verification of sterility assurance levels.

8. The sample size for the training set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning algorithms. The design and manufacturing process are informed by general engineering principles, material science, and the performance characteristics of predicate devices, rather than a data-driven training set.

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

This question is not applicable for the same reasons as #8.

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The proposed Gryphon T and P BR Anchors are intended for:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

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 proposed Gryphon T and P BR Anchors are absorbable suture anchors manufactured of “Biocryl Rapide” material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The Gryphon T and P BR Anchors are provided as size 3.0 mm. Each Gryphon T or P BR Anchor is provided sterile and is for single patient use only.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Gryphon T and P BR Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Gryphon T and P BR Anchors. Instead, it broadly states that "Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use."

The performance testing mentioned is "pull-out performance testing of the sample anchors under real-time aged conditions out to 26 weeks to show that the device meets its product specifications."

Without specific numerical criteria (e.g., "minimum pull-out strength of X Newtons for Y weeks"), a direct comparison table cannot be created.

However, based on the description, a conceptual table would look like this:

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

• Sample Size for Test Set: The text mentions "pull-out performance testing of the sample anchors." It does not specify the exact number (sample size) of anchors used in this testing.
• Data Provenance: The data provenance is internal testing conducted by the manufacturer, DePuy Mitek. The provided document does not indicate the country of origin of the data beyond the company's location in Raynham, MA, USA. It is a prospective study (performance testing of the new device).

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

This section is not applicable to the provided information. The study described is a mechanical performance study (pull-out strength), not a study requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" for this type of study is the measured physical performance (e.g., force required for pull-out).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Since this is a mechanical performance test, there is no human interpretation or adjudication involved in establishing the test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information describes mechanical performance testing of the device itself, not a study comparing human reader performance with or without AI assistance.

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

This section is not applicable. The device described is a physical bone anchor, not an AI algorithm. Therefore, "standalone algorithm" performance is irrelevant.

7. The Type of Ground Truth Used

The ground truth used for this performance study is objective physical measurement. Specifically, it refers to the measured pull-out performance of the anchors, compared against the "product specifications." This is a direct measurement of the device's mechanical properties, not a subjective assessment, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This section is not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This section is not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

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.

The Gryphon P BR Anchor is an absorbable suture anchor manufactured of "Biocryl Rapide" material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The suture option is provided without needles. The Gryphon P BR Anchor is provided as size 3.0 mm.

The provided text is a 510(k) Summary for the DePuy Mitek Gryphon P BR Anchor, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving performance against specific acceptance criteria for a novel device through clinical studies. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, human reader performance, or ground truth establishment.

Specifically, the document states:

• Substantial Equivalence: "The Gryphon P BR Anchor is substantially equivalent to the Gryphon BR Anchor (K073412, January 17, 2008)."
• Safety and Performance: "Based on the Indications for Use, technological characteristics and safety and performance testing, the Gryphon P BR Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act."
• Validation Testing: The submission includes "the results of validation testing (performance testing) for the device modification." However, detailed results or specific acceptance criteria are not provided in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets, as this information is not present in the provided 510(k) summary.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and performance through non-clinical testing, rather than extensive clinical efficacy trials against pre-defined acceptance criteria like those typically seen for novel devices that require PMAs or more comprehensive studies.

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Orthocord #2-0 suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Blue #6 or D&C Violet #2) absorbable polydioxnone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

The provided text describes a 510(k) premarket notification for a medical device, specifically a suture. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study with detailed metrics.

Therefore, many of the requested categories for "acceptance criteria" and "study proving device meets acceptance criteria" are not applicable in this context. The information provided is primarily related to regulatory classification, device description, and a claim of substantial equivalence.

Here's an analysis based on the provided documents:

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable. The submission states that "Non-clinical laboratory testing was performed." It does not specify a "test set" in the context of human data, nor does it provide details on sample sizes or data provenance for any testing beyond stating "non-clinical laboratory testing." This generally refers to in-vitro or bench testing, not human clinical trials.

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 information is relevant for studies involving expert review of data (e.g., medical images). The document describes non-clinical laboratory testing, not a study requiring expert-established ground truth.

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

• Not Applicable. This applies to studies where human experts are making judgments that need to be reconciled. This is not described in the document.

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

• No. An MRMC study is not mentioned. This type of study is relevant for evaluating diagnostic or interpretive AI systems, which is not the nature of this medical device (suture).

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

• Not Applicable. This device is a physical medical product (suture), not an algorithm or AI system.

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

• Not Applicable. For non-clinical lab testing of a suture, the "ground truth" would be established by physical measurements and material science standards (e.g., tensile strength, knot security, degradation rate) as defined by consensus standards like the USP monograph, rather than clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

• Not Applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this concept does not apply.

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

• Not Applicable. See point 8.

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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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The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankart Repair
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.

The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.

The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus and Mini QuickAnchor Plus with Orthocord sutures), which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices.

The information provided includes:

• Device Description: Explains the nature of the anchors and sutures.
• Proposed Indications for Use: Specifies the medical conditions and anatomical locations for which the devices are intended.
• Safety Information: Mentions biocompatibility studies demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
• Substantial Equivalence: Lists predicate devices to which the current device is deemed substantially equivalent.

There is no mention of:

• A table of acceptance criteria and reported device performance in terms of clinical or technical metrics.
• Sample sizes for test sets, data provenance, or details about training sets.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).

Therefore, based on the input document, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this type of information is not present in the provided 510(k) summary. These summaries historically focus on demonstrating equivalence through design, materials, and intended use to predicate devices, rather than presenting detailed prospective clinical trial data with specific performance metrics and acceptance thresholds.

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