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

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

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

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

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

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

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

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

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

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

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

Device: RC Loop Anchor with Dual Orthocord Suture

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

4. Adjudication method for the test set:

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

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

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

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

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

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

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

8. The sample size for the training set:

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

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

• How Ground Truth Was Established: Not applicable.

Summary of the Study:

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

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

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

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

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

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

The document explicitly states:

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

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

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

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

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

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

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

Instead, the document primarily focuses on:

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

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

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

(Hypothetical Example Based on a Fictional Performance Study)

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

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Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Sutures, Undyed are indicated for use in general soft tissue approximation and/or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissues. The Modified ETHICON Absorbable poly(1-lactide/glycolide Surgical Suture, is particularly useful where extended wound support (up to 6 months) is desirable.

Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a braided absorbable surgical suture prepared from a copolymer of lactide and glycolide and coated with a copolymer of caprolactone and glycolide.

The acceptance criteria and study details for the Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

• Orthopedic uses, including tendon and ligament repairs and reattachment to bone.
• Not for use in ophthalmic, cardiovascular, or neurological tissue. | - Intended for use in general soft tissue approximation and/or ligation.
• Indicated for orthopedic uses, including tendon and ligament repairs and reattachment to bone.
• Not for use in ophthalmic, cardiovascular, or neurological tissue. (Initially, the FDA letter mentioned use in ophthalmic procedures, but the "Indications for Use" statement explicitly excludes it, aligning with the "but not for use in ophthalmic, cardiovascular or neurological tissues" wording.) |
  | Technological Characteristics | - Same as the predicate device (existing ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed). | - The modified device has the same technological characteristics as the predicate device (existing ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed). |
  | Biocompatibility | - Biocompatible. | - Results indicated that the device was highly biocompatible. |
  | Functionality | - Functional within its indicated uses. | - Results indicated that the device was functional within its indicated uses. |
  | Breaking Strength Retention | - Performance comparable to predicate in terms of strength retention. | - Nonclinical laboratory testing was performed to determine breaking strength retention to assess safety and effectiveness. (Specific numerical values for retention are not provided in this summary, but the general finding of effectiveness suggests it met internal criteria.) |
  | Wound Support | - Desirable for extended wound support (up to 6 months). | - Particularly useful where extended wound support (up to 6 months) is desirable. |

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

• Sample Size: Not explicitly stated in the provided documents. The studies performed were "Nonclinical laboratory testing," "Biocompatibility and Functionality testing." The exact number of sutures or test subjects (if any animal models were used for some aspects) is not detailed.
• Data Provenance: The document does not specify countries of origin for the data. The studies are described as "Nonclinical laboratory testing" by ETHICON, Inc., which implies internal corporate testing.
• Retrospective or Prospective: Not explicitly stated, but typically, these types of laboratory and biocompatibility tests are conducted prospectively as part of product development and pre-market submission.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The studies were nonclinical laboratory and functionality tests, implying scientific and engineering experts involved in the testing and evaluation of material properties and performance.

4. Adjudication Method for the Test Set

• No information on adjudication methods is provided, as the studies are "Nonclinical laboratory testing" and "Biocompatibility and Functionality testing," not studies that would typically involve expert adjudication of interpretations.

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

• No, an MRMC comparative effectiveness study was not done. The approval is for a medical device (suture), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• No, a standalone algorithm performance study was not done. This device is a surgical suture, not a software algorithm.

7. The Type of Ground Truth Used

• For the nonclinical laboratory testing (e.g., breaking strength retention) and functionality testing, the "ground truth" would be established through objective physical and chemical measurements according to established scientific and engineering standards and protocols.
• For biocompatibility, the "ground truth" would be established through standardized in vitro and/or in vivo biocompatibility assays as per regulatory guidance (e.g., ISO 10993 series), comparing results against pre-defined safety limits or established biocompatible materials.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device refers to its manufacturing and processing.

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

• Not applicable. As noted above, this is not an AI/machine learning device. The "ground truth" for the device's development and manufacturing would relate to material specifications, manufacturing process controls, and quality assurance, which are established through engineering design, material science, and quality management systems.

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