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The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:

• Post-traumatic and degenerative arthritis.
• Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
• Revision after failed ankle arthrodesis with subtalar involvement.
• Failed total ankle arthroplasty.
• Non-union ankle arthrodesis.
• Rheumatoid hindfoot.
• Absent Talus (requiring tibiocalcaneal arthrodesis).
• Avascular necrosis of the talus.
• Neuroarthropathy or neuropathic ankle deformity.
• Neuromuscular disease and severe deformity.
• Osteoarthritis.
• Charcot Foot.
• Previously infected arthrosis, second degree.

The proposed DynaNail™ is a sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is implanted with a proprietary deployment frame and various lengths of fixation screws. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same manner as existing nails. The construction of the DynaNail™ body is equivalent to that of the VersaNail™ device. Both devices are made from Ti-6AL-4V Titanium, have a hollow body with flutes and distal and proximal screw attachment points. The DynaNail™ is offered in a 12 mm diameter, as is the VersaNail™. The DynaNail™ is offered in lengths comparable to those of the VersaNail™. The DynaNail™ device has an external frame that aligns the IMFR with the tibia and calcaneous and compresses the fusion site before insertion of the distal fixation screws. The DynaNail™ fusion site compression is a function of the compression applied by the external frame and the DynaNail™ Nitinol element.

Here's an analysis of the provided text regarding the MedShape Solutions DynaNail Ankle Nail, focusing on the acceptance criteria and study information:

The provided text is a 510(k) summary for the DynaNail Ankle Nail, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to a predicate device, rather than proving efficacy and safety through extensive clinical trials as an FDA PMA submission would.

Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating substantial equivalence to the predicate device, not necessarily on meeting independent performance benchmarks in a clinical setting in the way an imaging AI algorithm might.

Here's the breakdown based on your request, filling in "N/A" where the information is not provided or applicable to this type of device submission:

Acceptance Criteria and Device Performance Study for DynaNail Ankle Nail (K101934)

The primary acceptance criterion for the DynaNail Ankle Nail, as demonstrated in this 510(k) submission, is substantial equivalence to its predicate device, the DePuy Ace VersaNail™ Intramedullary Fixation Rod (K023115), in terms of design, function, intended use, and functional performance.

The study performed was a functional performance comparison with the predicate device, conducted per ASTM F 1264-03, "Standard Specification and Test Methods for Intramedullary Fixation Devices."

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact number of DynaNail and VersaNail™ devices or components tested for the functional performance studies (four-point bend, fatigue, nickel release, corrosion). Typically, these types of tests involve a statistically significant sample size based on engineering standards and regulatory guidance for device testing, but the specific number is not disclosed in this summary.
• Data Provenance: The data is based on prospective laboratory testing conducted by MedShape Solutions, Inc. on their DynaNail device and the predicate device. The country of origin of the data is implied to be within the USA, where MedShape Solutions is located.

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

• N/A. This type of device submission does not involve clinical testing with "ground truth" established by medical experts for a "test set" in the way an AI diagnostic device would. The "ground truth" for mechanical testing is defined by the ASTM standard's methodology and acceptance limits, and the comparison to the predicate device's performance.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving human interpretation or pathology, not for mechanical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC study is not applicable to an intramedullary fixation rod. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• N/A. The DynaNail Ankle Nail is a physical implantable medical device, not an algorithm, so "standalone performance" in this context is not applicable. The functional performance tests described are essentially "standalone" device performance evaluations in a laboratory setting.

7. The Type of Ground Truth Used:

• For the functional performance testing, the "ground truth" or reference for evaluating performance was defined by:
  • ASTM F 1264-03 Standard Specification and Test Methods: This standard outlines the methodology and expected performance characteristics for intramedullary fixation devices.
  • Performance of the Predicate Device (DePuy Ace VersaNail™): The DynaNail was tested against the predicate, with the acceptance being that its performance is "substantially equivalent" to (i.e., not worse than) the predicate under the defined test conditions.

8. The Sample Size for the Training Set:

• N/A. The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.

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

• N/A. (See point 8).

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The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

The ExoShape™-XL Interference Fixation Device is a line extension offering additional sizes within the current cleared product line and is substantially equivalent to the ShapeLoc (original product name) Soft Tissue Fastener, cleared under K101808. The technological characteristics of the ExoShape™-XL and the ShapeLoc Interference Fixation Devices are equivalent.

The provided text describes a Special 510(k) submission for the MedShape Solutions ExoShape™-XL Interference Fixation Device, which is a line extension of an already cleared device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device.

Therefore, the requested information about acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document. This document is a regulatory submission for a device modification (line extension) based on substantial equivalence, not a detailed clinical or performance study report with explicit acceptance criteria and corresponding results as typically seen for entirely new devices or software.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list numerical acceptance criteria. Instead, it states that "Functional performance testing was conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength and other dimensional verification. Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the listed devices."

This implies that the acceptance criterion was likely substantial equivalence in performance (particularly fixation strength and dimensional characteristics) compared to the predicate devices. The "reported device performance" is that it met this substantial equivalence.

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

• Sample Size: Not explicitly stated. The document mentions "functional performance testing" was conducted but does not provide details on the number of samples (devices, Sawbones, or porcine bones) used.
• Data Provenance: The testing was conducted in "Sawbone® and porcine bone analogues." This indicates that the data is from pre-clinical, in-vitro (Sawbone) and ex-vivo (porcine bone) testing. The document does not mention human data (prospective or retrospective).

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

• Not applicable to this type of submission. This device is a physical medical implant, and the testing described is mechanical performance (fixation strength, dimensions), not diagnostic or interpretative. Thus, there is no "ground truth" established by human experts in the context of interpretation, nor are there experts involved in establishing a "ground truth" for mechanical testing in the way that there would be for, say, an AI-powered image analysis system.

4. Adjudication method for the test set:

• Not applicable. As described above, this is mechanical performance testing, not expert interpretation.

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 a physical medical device (implant) and not an AI-powered system designed to assist human readers or perform diagnostic tasks. Therefore, no MRMC study would be relevant or conducted.

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

• Not applicable. This is a physical medical device (implant), not an algorithm or AI system. Its performance is inherent in its mechanical properties.

7. The type of ground truth used:

• For the mechanical functional performance testing (e.g., monotonic soft tissue fixation strength, dimensional verification), the "ground truth" would be established by engineering measurements and biomechanical test standards/protocols. The performance of the predicate devices would serve as a benchmark against which the new device's performance is compared to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

• Not applicable. (See #8).

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The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair. Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

The proposed ShapeLoc™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The ShapeLoc™ Soft Tissue Fastener is designed to use the principles of interference fit to reattached soft tissue intended for attachment into a hole created in bone. The ShapeLoc™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue against the bone wall; fastening it into place.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ShapeLoc™ Soft Tissue Fastener:

The document provided is a 510(k) summary for a medical device called the "ShapeLoc™ Soft Tissue Fastener." This type of submission is for demonstrating substantial equivalence to a predicate device, not necessarily for proving the absolute safety and effectiveness of a novel device through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating equivalence in performance characteristics to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with specific numerical thresholds for success, as might be seen in a clinical trial protocol. Instead, the document frames the assessment around "substantial equivalence" to the predicate device, the Arthrex Interference Screw (K062466), across various functional performance tests. The performance goal is to be comparable to or better than the predicate device in relevant mechanical properties.

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

The document does not explicitly state the specific sample sizes used for the functional performance testing. It mentions "Sawbone® and porcine bone analogues" as the materials for testing, implying an in-vitro or ex-vivo experimental setup. The data provenance is from this laboratory testing; there is no mention of human subject data, retrospective, or prospective studies in this summary.

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

This type of information is not applicable to the data presented in this 510(k) summary. The "ground truth" for the performance testing is based on objective measurements of mechanical properties (e.g., force required for pull-to-failure, displacement during dynamic loosening) from laboratory tests on bone analogues, not on expert interpretations of clinical data. Therefore, there were no experts establishing "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable to the data presented. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret medical images or clinical data to reach a consensus ground truth. The presented study involves objective mechanical testing, where the "truth" is derived from direct measurements and engineering analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The 510(k) summary describes laboratory-based mechanical performance testing for substantial equivalence, not a clinical diagnostic performance study. There is no AI component mentioned in the context of human reader improvement.

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

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI algorithm. The performance evaluation is of the fastener's mechanical properties, not an algorithm's diagnostic or predictive capabilities.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this context is based on objective mechanical measurements obtained from testing the device in "Sawbone® and porcine bone analogues." This includes measurements like force (for pull-to-failure) and displacement (for dynamic loosening). This is an engineering ground truth, not a clinical ground truth like pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical implant, not an AI model that requires a training set. The term "training set" is relevant for machine learning algorithms.

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

This is not applicable, as there is no training set for a physical implant device.

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The MedShape Solutions, Inc., WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
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, Achilies Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

The proposed WedgeLoc™ 2.5mm Suture Anchor is an extension of sizes offered and is substantially equivalent to the WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, and the predicate Arthrex PushLock™ 2.5mm Suture Anchor, cleared under K063479, in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ 2.5mm Suture Anchor are equivalent.

The provided document is a 510(k) summary for a medical device (WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Suture). This type of document is a submission to the FDA (Food and Drug Administration) to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as existing products.

It is crucial to understand that 510(k) submissions, particularly for devices like suture anchors, typically do NOT include clinical studies or performance data comparing the device against acceptance criteria in the manner that AI/software as a medical device (SaMD) clearances do. For predicate-based devices, the focus is on demonstrating equivalence in design, materials, manufacturing processes, and sometimes non-clinical performance (e.g., mechanical testing) to an already cleared device. Clinical efficacy is generally inferred from the predicate device's history of safe and effective use.

Therefore, the specific information requested in the prompt, such as acceptance criteria based on accuracy metrics (sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not relevant or applicable to this type of device submission and are not found in the provided document.

The document discusses "substantial equivalence" based on:

• Identical Intended Use: The device is indicated for the same types of procedures and anatomical locations as its predicate (K091202).
• Similar Technological Characteristics: The proposed device is an "extension of sizes offered" and shares basic features with the predicate devices (K091202 and K063479).
• Minor Differences: Any differences are considered minor and do not raise new questions of safety or effectiveness.

In summary, this document does not contain the information you've requested because it's a submission for a mechanical medical device (suture anchor) demonstrating substantial equivalence to a predicate, not a software or AI-based device requiring clinical performance validation against specific accuracy metrics.

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The MedShape Solutions, Inc., WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:

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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures

This document, K091202, is a Special 510(k) summary for the MedShape Solutions WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures. It asserts substantial equivalence to a previously cleared device (K083792) and other predicate devices, rather than detailing a new study with specific acceptance criteria and performance data for the 180X model itself.

Therefore, many of the requested categories for a new clinical study are not directly applicable or available in this submission. This 510(k) is primarily focused on demonstrating that the minor changes to the WedgeLoc™ suture anchor (the "180X" designation) do not raise new questions of safety and effectiveness, and thus do not require new acceptance criteria or a dedicated study for the device's performance against such criteria.

Here's the breakdown of what can be extracted from the provided text, and what cannot:

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

No explicit acceptance criteria or reported device performance against such criteria are provided for the WedgeLoc™ 180X Suture Anchor in this document. The submission argues for substantial equivalence based on the predicate device's established performance and the minor nature of the changes.

2. 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 510(k) does not describe a new clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This 510(k) does not describe a new clinical study with a test set and ground truth establishment.

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

Not applicable. This 510(k) does not describe a new clinical study with a test set and adjudication.

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 medical implant (suture anchor), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant (suture anchor), not an algorithm.

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

Not applicable. This 510(k) does not describe a new study that required ground truth establishment. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This 510(k) does not describe a machine learning model or a training set.

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

Not applicable. This 510(k) does not describe a machine learning model or a training set.

Summary of the document's content relevant to acceptance criteria and study:

The core of this Special 510(k) is the assertion that the WedgeLoc™ 180X Suture Anchor is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K083792) and the Arthrex PushLock™ Suture Anchor (K051219).

• Acceptance Criteria: The implied "acceptance criteria" for this Special 510(k) are that the minor differences between the new device and its predicates do not raise new questions concerning safety and effectiveness. This is a regulatory acceptance criterion for the submission itself, not a performance criterion for the device in a clinical study.
• Study That Proves the Device Meets Acceptance Criteria: The "study" isn't a new clinical trial but rather a comparative analysis of the technological characteristics of the WedgeLoc™ 180X Suture Anchor against its predicate devices. The document states:
  • "The proposed WedgeLoc™ 180X Suture Anchor is is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K08379) and the Arthrex PushLock™ Suture Anchor (K051219) in which the basic features and intended uses are the same."
  • "In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ Suture Anchors are equivalent."
  • "Any differences between the WedgeLoc™ 180X Suture Anchor and the predicate WedgeLoc™ or Arthrex PushLock™ Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness."

In essence, the "proof" is the argument of substantial equivalence based on a comparison of features, intended use, and technological characteristics, rather than new device-specific performance data. The device's performance is accepted as equivalent to the already cleared predicate devices.

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The MedShape Solutions, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis in the following procedures:

• Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Shoulder: Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Foot/Ankle: Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
• Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee: Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction

The proposed WedgeLoc™ Suture Anchor is a sterile, single use, two piece "push-in" bone anchor. The suture anchor is designed to use the principles of compression to force the eyelet, pre-loaded with non-absorbable suture, into a hole created in the bone. The suture anchor body is comprised of a crosslinked Methyl methacrylate (MMA) polymer (comprised of Memori™ 7111. refer to MAF #1533) and PEEK eyelet (comprised of PEEK-OPTIMA® by Invibio®, refer to MAF #1209).

Each suture anchor is preloaded with two non-absorbable USP No. 2 sutures. The polyblend surgical suture provided with the proposed WedgeLoc™ Suture Anchor is provided by CP Medical, and has previously been cleared for market under K041894. In addition, these sutures meet USP requirements as described in the USP monograph for non-absorbable surgical sutures. Opti-Fiber™ non-absorbable polyblend surgical sutures are made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover and are identical to the CP-Fiber™ USP No. 2 sutures described in K041894.

This is a 510(k) summary for a medical device called the WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures. This document aims to demonstrate substantial equivalence to predicate devices, rather than establishing primary safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance reporting as one might expect for a novel device.

The "study" referenced in this document is an in-vitro functional performance testing to show the new device performs at least as well as the predicate.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a quantitative table for "device performance." Instead, it relies on demonstrating that the proposed device performs "as well as or better than" the predicate device in functional performance testing.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "functional performance testing," but the number of samples or tests conducted is not provided.
• Data Provenance: In-vitro (laboratory testing, not human or animal data).

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

Not applicable. The ground truth for this type of test is typically based on engineering specifications and direct measurement of mechanical properties, rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was an in-vitro functional test, not a study requiring adjudication of expert opinions or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a medical device (suture anchor), not an AI or imaging device that would typically involve MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

The ground truth for the in-vitro functional performance testing would be the measured mechanical properties of the suture anchor and its fixation strength in bone analogues, compared against the known performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this type of device submission.

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