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

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

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

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

Device: RC Loop Anchor with Dual Orthocord Suture

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

4. Adjudication method for the test set:

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

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

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

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

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

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

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

8. The sample size for the training set:

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

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

• How Ground Truth Was Established: Not applicable.

Summary of the Study:

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

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

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

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

Ankle: Achilles tendon repair/reconstruction.

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

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

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

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

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

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

Here's what can be extracted and what cannot:

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

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

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

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

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

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

• Not applicable. This was bench testing.

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

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

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

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

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

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

8. The sample size for the training set

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

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

• Not applicable.

Summary of what the document does communicate regarding device performance:

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

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

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

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

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

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

Instead, the document states:

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

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

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

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

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

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

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

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

The ground truth used was based on:

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

8. Sample Size for the Training Set

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

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

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

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