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The Mitek Biocryl Rapide Interference Screw is intended for fixation of soft tissue or bone tendon bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Mitek Biocryl Rapide Interference Screw

The provided text describes a 510(k) premarket notification for the Mitek Biocryl Rapide Interference Screw. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than performing a de novo clinical study with acceptance criteria and detailed performance data in the way a new AI/software medical device might.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable to this document.

The document does provide information under "Safety and Performance" but states the determination of substantial equivalence was based on:

1. A detailed device description.
2. Conformance to consensus standards and voluntary standards.
3. Comparison to the predicate device.

It explicitly concludes that "Based on the indications for use, technological characteristics, and comparison to the predicate device, the Mitek Biocryl Rapide Interference Screw has been shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."

No clinical study with acceptance criteria and performance metrics for the device's function (e.g., successful fixation rate, biomechanical strength in vivo, etc.) is described in this 510(k) summary. The FDA's letter confirms substantial equivalence based on the provided information, not on a new clinical trial proving specific performance metrics against pre-defined acceptance criteria.

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The Bio-INTRAFIX Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.

The Mitek Bio-INTRAFIX Tibial Screw and Sheath is an absorbable fixation implant for the repair of soft tissue grafts during ligament reconstruction. Bio-INTRAFIX is a two-part system designed to fixate soft tissue to bone for ligament reconstruction.

This 510(k) summary (K032167) for the Bio-INTRAFIX Tibial Tapered Screws and Sheaths does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it relies on substantial equivalence to predicate devices and general compliance with standards. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. No specific test set for performance evaluation is described.
• Data Provenance: Not applicable. No specific study data is presented.

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. No test set requiring ground truth establishment by experts is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set is described.

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 device is a physical surgical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device.

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

• Standalone Performance Study: No. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No specific study with ground truth is described. The approval is based on substantial equivalence to predicate devices.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This is a physical implant, not a machine learning model, so there is no "training set."

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

• Ground Truth Establishment (Training Set): Not applicable. As there is no training set, there's no ground truth to establish for it.

Summary from the Document:

The document asserts substantial equivalence based on:

• A detailed device description.
• Conformance to consensus standards and voluntary standards.
• Comparison to predicate devices (IntraFIX (K983560) and Biocryl Interference Screws (K013572)).

This 510(k) submission is a "traditional" submission for a physical medical device, where equivalence is primarily argued through similar design, materials, intended use, and existing regulatory clearance of comparable predicate devices, rather than through complex performance studies with specific acceptance criteria as might be seen for novel diagnostic tools or AI/ML-driven devices.

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MITEK Micro QuickAnchor is intended to attach suture into bone for the suspension of the nasal valve. MITEK Micro QuickAnchor is intended to attach suture into bone at the lower orbital rim.

MITEK anchors are titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.

The provided text is a 510(k) summary for the MITEK Micro QuickAnchor, a medical device. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance in the way a new diagnostic or AI-driven device might.

Therefore, many of the requested elements (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used) are not applicable or extractable from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by comparing design, materials, and intended use.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary in terms of quantitative performance metrics or acceptance criteria for a new study. The document focuses on regulatory clearance by demonstrating "substantial equivalence" to previously cleared devices.

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

Not applicable/provided. This device is a physical implant, not a diagnostic or AI algorithm that would typically involve a "test set" of data in this context. The substantial equivalence is based on device design, materials, and use, not a clinical data-driven performance study in the traditional sense for a new device.

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

Not applicable/provided. "Ground truth" in this context (a physical implant) would refer to clinical outcomes, which are not detailed as part of this 510(k) summary’s comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable/provided.

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

Not applicable/provided. MRMC studies are typically for diagnostic imaging interpretation or similar medical AI applications, not for physical implants.

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

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

7. The Type of Ground Truth Used

Not explicitly stated or applicable as for a diagnostic device. The "ground truth" for a physical implant would relate to its safety and effectiveness in surgical applications, which is typically addressed through clinical experience with similar predicate devices and, if necessary, clinical trials (though not detailed here for a 510(k)).

8. The Sample Size for the Training Set

Not applicable/provided. This is a physical device, not an AI model requiring a training set.

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

Not applicable/provided.

Summary of Extracted Information:

Acceptance Criteria and Device Performance:

• Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are that the MITEK Micro QuickAnchor is "substantially equivalent" in terms of safety and effectiveness to predicate devices already on the market. This is a regulatory standard rather than a specific performance metric.
• Reported Device Performance: The document does not report specific performance metrics for the MITEK Micro QuickAnchor from a new study. Instead, its safety is referenced by its clearance through pre-market notifications (K962793, K962511, K982420) for its predicate devices, implying similar expected performance.

Study Type and Design:

• The text describes a 510(k) premarket notification process, which aims to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria as you might see for a completely novel device or an AI/diagnostic tool.
• Predicates Referenced: K962793, K962511, K982420.

Device Description:

• Device Name: MITEK Micro QuickAnchor
• Classification Name: Staple, Fixation, Bone
• Common/Usual Name: Suture Anchor
• Device Description: Titanium alloy implants used to anchor or lock suture within bony sites for firmly securing soft-tissue to bone.
• Intended Use: To attach suture into bone for the suspension of the nasal valve and at the lower orbital rim.

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MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:

Ankle: Mid-foot reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction

The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested analysis. The document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus bone anchor) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices for regulatory approval.

Here's why I cannot fulfill your request based on the provided text:

• No Acceptance Criteria or Device Performance Table: The document does not specify any quantitative acceptance criteria or report specific performance metrics from a study that would demonstrate the device meets those criteria. The only safety information provided is a general statement about "Biocompatibility studies have demonstrated the MINILOK QuickAnchor Plus to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." This is a qualitative statement, not a performance metric with acceptance criteria.
• No Description of a Study for Performance Evaluation: The text does not describe any specific study (clinical trial, bench test with performance endpoints, etc.) that was conducted to prove the device meets performance criteria. The mention of "biocompatibility studies" is the only hint of testing, but no details are given about their methodology, sample size, or results in relation to performance criteria.
• Missing Information for AI/Algorithm-Specific Questions:
  • The device described (bone anchor) is a physical medical device, not an AI or algorithm-driven product. Therefore, questions related to AI performance, sample sizes for test/training sets, ground truth establishment for algorithms, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and cannot be answered from this document.

In summary, the provided document is a regulatory submission for a physical medical device, not a performance study report for an AI/algorithmic medical device. Therefore, it lacks all the specific information you've requested regarding acceptance criteria, study details, and AI-related metrics.

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The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.

The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle. Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.

Here's an analysis of the provided text regarding the CUFFLOK Anchor's acceptance criteria and studies:

Summary of Device and Approval:

The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair. It is intended to secure soft tissue to bone. The FDA granted substantial equivalence (K031519) to the CUFFTACK Anchor (K003076) based on the information provided.

Acceptance Criteria and Study Details for CUFFLOK Anchor:

The provided document does not contain information about specific acceptance criteria related to a performance study with defined metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical strength values) and subsequent reporting of device performance against these criteria.

Instead, the approval for the CUFFLOK Anchor appears to be based on demonstrating substantial equivalence to a predicate device (CUTTACK Anchor) and confirming biological compatibility.

Below, I've structured the answer based on the questions, indicating where information is present or absent in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility: Non-toxic	Demonstrated to be non-toxic (as stated in the "Safety" section).
   Biocompatibility: Non-irritating	Demonstrated to be non-irritating (as stated in the "Safety" section).
   Biocompatibility: Non-sensitizing	Demonstrated to be non-sensitizing (as stated in the "Safety" section).
   Biocompatibility: Non-cytotoxic	Demonstrated to be non-cytotoxic (as stated in the "Safety" section).
   Substantial Equivalence: Similar indications for use (shoulder rotator cuff repair)	Met: Indicated for shoulder rotator cuff repair, same as predicate (implied by FDA's substantial equivalence determination).
   Substantial Equivalence: Similar technology/design (three-part polymer implant, delivery method via trocar/Delivery Gun)	Met: "Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun."
   Performance (e.g., mechanical strength, pull-out force, tissue integration, etc.)	Not specified/Explicitly reported in the provided text. The document relies on substantial equivalence to the predicate for assumed performance.

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

   • Sample Size: Not specified. The document refers to "biocompatibility studies" but does not detail the sample size or design of these studies. No performance "test set" in the context of an AI/software device is mentioned.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

   • Not applicable. The document does not describe a process involving human experts to establish ground truth for a test set, as this is a physical medical device, not an AI/software product requiring image interpretation or similar.

4. Adjudication Method for the Test Set:

   • Not applicable. No test set requiring expert adjudication is described.

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

   • No. The document makes no mention of an MRMC study. This type of study is typically relevant for interpretative AI devices where human performance with and without AI assistance is evaluated.

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

   • No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

   • The "ground truth" for the CUFFLOK Anchor in the context of this submission appears to be:
     • Biocompatibility test results: Demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
     • Design and Material Equivalence: Comparison to the predicate device (CUTTACK Anchor) for design, materials (PLA, polypropylene), and intended use. The FDA's substantial equivalence finding validates this comparison.
   • No pathology, imaging, or outcomes data used as "ground truth" for performance comparison is described in this document.

8. Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. No training set is involved.

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The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.

Mitek's EXOJET Tissue Management System consists of reusable power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills.

The EXOJET Tissue Management System is a medical device for orthopedic surgical procedures performing functions such as cutting, evacuation, and electrocauterization. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML device.

Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance, cannot be extracted from this document. The document describes a traditional medical device (arthroscope and accessories) and its functions, and its FDA clearance process through substantial equivalence. There is no mention of any AI/ML components or associated performance metrics like sensitivity, specificity, or AUC, nor any studies evaluating such performance with human readers.

Below is a table summarizing the information that can be extracted or inferred from the provided text, primarily regarding the device and its regulatory clearance process, rather than AI/ML-specific performance studies.

Table of Acceptance Criteria and Reported Device Performance

As for the specific points related to AI/ML device studies:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not describe an AI/ML study.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For biocompatibility, the "ground truth" would be results from standard biocompatibility tests. For functional equivalence, it would be direct comparison to the predicate device.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text is for a conventional medical device seeking 510(k) clearance, not an AI/ML-powered device. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML performance evaluation, are not present. The "study" referenced in the document implicitly refers to the testing and comparisons performed to establish substantial equivalence and biocompatibility, as required for a 510(k) submission, rather than a clinical performance study with statistical endpoints for an AI/ML algorithm.

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The MICROFIX QUICKANCHOR Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Hand: Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal) and MCP (metacarpal interphalangeal) joints for all digits. Skull: Soft tissue attachment to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and periorbital bones of the skull.

The MICROFIX QUICKANCHOR Plus is a bioabsorbable polymer implant designed for reattachment of soft tissue to bone. Similar to the currently marketed MICRO Anchor, the implant is mounted on a disposable inserter assembly and placement of the implant is facilitated via use of a sterile, disposable drill bit. There have been no modifications to the drill bit for use with the MICROFIX QUICKANCHOR Plus device.

Here's the analysis of the provided text regarding the acceptance criteria and study for the MICROFIX QUICKANCHOR Plus device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K024115) is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a study detailing specific acceptance criteria and performance against those criteria. In these types of submissions, the "acceptance criteria" are implied by demonstrating substantial equivalence to existing, legally marketed devices.

Therefore, the "acceptance criteria" is that the device must be shown to be substantially equivalent to the predicate devices in terms of technological characteristics, safety, and performance.

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

• Sample Size for Test Set: Not applicable. This submission does not describe a clinical study with a "test set" of patients in the typical sense. The evaluation was primarily non-clinical.
• Data Provenance: Not applicable. No clinical data was used or generated for this submission. The "testing" mentioned is non-clinical.

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

• Not applicable. As no clinical test set was used, no experts were needed to establish ground truth from patient data. The ground truth, in the context of a 510(k), is implicitly established by the predicate devices being legally marketed and deemed safe and effective.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or human interpretation was involved that would require an adjudication method.

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 bioabsorbable polymer implant (suture anchor), not an AI-based diagnostic tool. No MRMC study or AI component is mentioned.

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

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

7. The type of ground truth used:

• The "ground truth" for this 510(k) submission is the established safety and efficacy profile of the predicate devices (MICRO Anchor, ReSolve QuickAnchor, and BIOFASTIN RC suture anchors). The new device is evaluated against these predicates through non-clinical testing to demonstrate similar performance and characteristics.

8. The sample size for the training set:

• Not applicable. This submission does not involve machine learning or AI, and therefore no "training set" in that context. The "training" in the context of device development would refer to the iterative design and testing process, but not a dataset for an algorithm.

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

• Not applicable. As there is no training set mentioned in the context of AI/ML, there is no ground truth established for it. The comparison is based on the known properties and regulatory approval of the predicate devices.

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The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

The RAPIDLOC-PDS Meniscal Repair System consists of a two piece (polydiaxonone tophat and polylactic acid backstop) bioabsorbable meniscal tissue fixation implant mounted on a 2/0 pre-knotted PANACRYL braided long-term absorbable suture. It is applied using a cannulated needle and arthroscopic pusher.

The provided text describes a 510(k) premarket notification for the Mitek RAPIDLOC-PDS Meniscal Repair System. This is a medical device, not a software algorithm or AI. Therefore, the questions related to acceptance criteria, study details for AI/software performance, ground truth, sample sizes for training/test sets, MRMC studies, and standalone algorithm performance are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and shared technological characteristics.

Here's a summary of the relevant information provided:

Device: Mitek RAPIDLOC-PDS Meniscal Repair System

Device Type: Biodegradable Fixation Fastener for meniscal repair.

Intended Use: Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

A "Summary of Non-clinical Test" was conducted. The document states: "Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified."

Regarding AI/Software Specific Questions:

1. Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/software. No specific "test set" in the AI sense is mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable. The "ground truth" for a physical device like this would be its physical and mechanical properties, biocompatibility, and functional performance, which are assessed through non-clinical testing.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Clinical Data:

The document explicitly states: "Clinical Data: Not Applicable". This indicates that the device's substantial equivalence and suitability for its intended use were established through non-clinical testing and comparison to predicate devices, without requiring new human clinical trials for this 510(k) submission.

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The Mitek PDS/PGA Staple is an absorbable implant used in the fixation of scaffolding (for example periosteal autograft, collagen membranes or synthetic scaffolding) to articular cartilage lesions of the knee.

The Mitek PDS/PGA Staple is a sterile, implantable device intended for single patient use only. The PDS/PGA Staple consists of an injection molded polydioxanone (PDS) U-shaped strap and two injection molded polyglycolic acid (PGA) cones. The PDS U-shaped strap is insert-molded around the two injection molded PGA cones, resulting in a single, mechanically joined, PDS/PGA Staple construct. The PDS/PGA Staple is manufactured from two absorbable polymers that are well-known and well-characterized and have been used in a multitude of commercially available medical devices.

The provided text is a 510(k) summary for the Mitek PDS/PGA Staple. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria or detail a specific study with performance metrics in the way one might expect for an AI/ML device.

This document focuses on demonstrating substantial equivalence to existing, legally marketed devices. The "safety and performance" section refers to studies, but these are to show equivalence, not to meet specific, quantifiable performance targets set as acceptance criteria for a novel device.

Therefore, many of the requested categories cannot be directly answered from the provided text because it's a submission for a medical device that established substantial equivalence through in vitro and in vivo animal studies, and biocompatibility data, rather than a comparative effectiveness study with human readers or AI algorithms.

Here's a breakdown of what can be extracted and what cannot:

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

• Biocompatibility data
• In vitro strength retention assessment
• Simulated use evaluation
• In vivo animal studies |
  | Safety Profile | Data provided supports safety and performance. |
  | Performance Profile | Data provided supports safety and performance to be substantially equivalent to currently marketed devices. |
  | Materials | Manufactured from two absorbable polymers (PDS and PGA) that are well-known and well-characterized. |
  | Operating Principle | Similar to predicate devices. |
  | Intended Use | Fixation of scaffolding to articular cartilage lesions of the knee, similar to predicate devices. |
  | Manufacturing Processes | Similar to predicate devices. |
  | Sterilization Processes | Similar to 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)

• Sample Size for Test Set: Not specified. The document mentions "in vitro strength retention assessment," "simulated use evaluation," and "in vivo animal studies," but does not provide specific sample sizes for these.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally.

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

• Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation. The performance is assessed through laboratory and animal studies, not human expert evaluations for a test set.

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

• Not applicable for a medical device of this type. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple reviewers.

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. This is not an AI/ML device, and an MRMC study is not relevant to its type of submission.

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

• No. This is not an AI/ML algorithm.

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

• The "ground truth" for this device's performance would be derived from the specific metrics measured in the biocompatibility data, in vitro strength retention assessment, simulated use evaluation, and in vivo animal studies. For example, in vitro strength retention might be measured against a predefined mechanical standard, and in vivo animal studies would assess biological response and tissue integration. These are objective measurements rather than expert consensus on interpretative data.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.

The BIOFASTIN RC Threaded Suture Anchor is an absorbable, threaded suture anchor. The BIOFASTIN RC anchor has 2 threads of an auger-type design with an overall nominal diameter of 5.0 mm and nominal length of 11.5 mm. The device has two suture holes (90 degrees apart) in the anchor head for fixation of #2 suture to bone (sutures provided pre-attached with affixed tapered needles). The sutures provided with the BIOFASTIN RC are either the ETHIBOND non-absorbable or PANACRYL absorbable sutures.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device (BIOFASTIN RC Threaded Suture Anchor), and it primarily focuses on establishing substantial equivalence to predicate devices, not on detailing specific performance acceptance criteria or a study demonstrating the device meets those criteria.

The "Safety and Performance" section states: "Results of performance testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This is a high-level statement and does not provide the specific details required to answer your request, such as a table of acceptance criteria, sample sizes, ground truth establishment, or study types.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.

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