Search Results

The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The JuggerStitch Meniscal Repair Device is a permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves. The device comes as a unit, pre-assembled on either a Straight or Curved inserter. The purpose of this submission is to introduce modifications to the Juggerstitch suture implant and inserter for ease of use.

This document is a 510(k) Premarket Notification for the JuggerStitch Meniscal Repair Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven device. As such, the information required to answer the prompt directly, especially regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truths for an algorithm, is not present in this document.

The document discusses non-clinical tests performed to verify the physical characteristics and performance of the mechanical device due to modifications made to a previously cleared device. These include:

• Static tensile testing: To verify the strength of the implant.
• Cantilever bend testing: To verify the bending strength of the inserter needles.
• Tissue penetration force testing: To verify the penetration force of the inserter needles.
• Advancement testing: To verify the force required to advance the depth adjuster and push button.
• Surgeon validation: To assess if the device meets its intended User Needs (related to ease of use of modifications).
• Sterilization validations: To show compliance with ISO standards.
• Packaging validations: To show compliance with ISO standards.

The document explicitly states: "Clinical data was not required to establish substantial equivalence between the subject JuggerStitch Meniscal Device and the predicate devices." This confirms that there was no clinical study, let alone one involving AI or algorithms, to assess the device's performance in a diagnostic or predictive capacity.

Therefore, I cannot provide the requested table and study details as they pertain to algorithm performance and acceptance criteria. The provided text describes a submission for a mechanical meniscal repair device, not a software or AI-driven medical device.

Ask a specific question about this device

The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. buckethandle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The JuggerStitch Meniscal Repair Device is a permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves. The device comes as a unit, preassembled on either a straight or curved inserter.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device, the JuggerStitch Meniscal Repair Device, and primarily focuses on establishing substantial equivalence to a predicate device.

Here's what I can extract and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "non-clinical laboratory testing was performed to verify the fixation strength of the JuggerStitch Meniscal Repair Device in mechanical testing as compared to the MaxFire MarXmen Meniscal Repair Device." It then states, "The test results indicate that the JuggerStitch Meniscal Repair Device provides equivalent fixation strength to the predicate device and would be functional within their intended use."

However, specific numerical acceptance criteria (e.g., minimum fixation strength in Newtons) and the exact reported performance values for both the JuggerStitch and the predicate device are not provided. Therefore, a table with specific acceptance criteria and reported performance cannot be generated from this text.

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

• Sample Size: Not specified in the document.
• Data Provenance: The document states "non-clinical laboratory testing was performed." It does not mention country of origin or whether it was retrospective or prospective, though "non-clinical laboratory testing" typically implies a controlled, prospective lab setting.

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

• Not applicable as this was non-clinical mechanical testing, not a study requiring expert clinical ground truth assessment.

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

• Not applicable as this was non-clinical mechanical 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:

• No MRMC or human-in-the-loop study was mentioned. The device is a physical medical device, not an AI or imaging diagnostic tool.

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

• Not applicable as this is a physical medical device.

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

• For the non-clinical mechanical testing, the "ground truth" or reference was the fixation strength of the predicate device. The goal was to show equivalence.

8. The sample size for the training set:

• Not applicable. This document describes a non-clinical performance test for a physical device, not a machine learning model that would have training data.

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

• Not applicable.

In summary, the provided document is a 510(k) summary that focuses on demonstrating substantial equivalence through comparison to a predicate device, primarily via non-clinical mechanical testing. It does not provide the detailed quantitative data, sample sizes for mechanical testing beyond a general statement, or information on clinical studies, expert reviews, or AI performance metrics.

Ask a specific question about this device

The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.

The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.

The provided text describes a medical device, the A.I.M. Knotless Meniscal Repair Device, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with diagnostic AI/imaging devices.

The document states: "Bench testing was conducted to confirm that the A.I.M. Knotless Meniscal Repair Device performs as well or better than the predicate on pull-out performance and cyclic loading." This indicates performance testing was done, but the specific acceptance criteria (e.g., minimum pull-out strength in Newtons, number of cycles survived at a certain load) and the detailed results are not provided in the given text.

Therefore, I cannot fill out the requested table or answer most of the questions as the necessary data is absent from the provided text.

Here's what I can infer from the text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

All other requested information regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, training set details, and ground truth establishment methods is not available in the provided document, as it focuses on a a physical medical device (suture retention device) and its substantial equivalence and not an AI or imaging diagnostic device. The 'study' mentioned is a bench test to compare mechanical properties with a predicate, not a clinical or AI performance study.

Ask a specific question about this device

The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and redwhite zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of a size 2-0 polyethylene/polypropylene ZipLoop™ construct with two #5 polyester sleeves. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeves lock against the meniscal tissue, pulling the tear together. The sleeves control the size of the knot ensuring that the anchor does not become too small and pull through the meniscal tissue. The anchors are pre-loaded onto an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. The insertion device is available as an in-line inserter or a pistol-grip inserter, the MaxFire™ MarXmen™ Meniscal Repair Device. This allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the knotted end of the ZipLoop™ construct is gently pulled by the surgeon, allowing the meniscal tear to be compressed. The Maxfire™ anchor sits on the back side of the meniscus.

The medical device referenced is the "MaxFire™ and MaxFire™ MarXmen™ Meniscal Repair Devices".

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data. The performance data provided is from non-clinical (mechanical) testing. No information is given about the sample size (number of devices or tests performed) for the fixation strength testing. The provenance of the data is also not stated (e.g., country of origin, retrospective or prospective).

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

Not applicable. This device is a mechanical implant, and the assessment is based on physical performance (fixation strength) rather than expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication was required for mechanical testing results.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "None provided as a basis for substantial equivalence" under the "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION."

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

Not applicable. This is not an AI/algorithm-based device. It is a mechanical medical implant.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's main performance characteristic (fixation strength) was based on mechanical test results comparing it to a legally marketed predicate device. The acceptance criteria were derived from the performance of the predicate device (Arthrotek® MaxFire™ Meniscal Repair Device - K061776).

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense.

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

Not applicable. As above, there is no training set for this type of device. The mechanical properties were evaluated against pre-defined acceptance criteria based on the predicate device's performance.

Ask a specific question about this device

The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

The ConMed Linvatec Sequent™ Meniscal Repair Device is an all-inside meniscal repair device that sequentially deploys implants and suture. This device allows the surgeon to generate multiple stitches in order to create fixation points along a soft tissue tear. The hand held, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The implant encompasses a cleat which retains the suture and allows the knotless feature.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study proving the device meets those criteria. The provided text is a summary of safety and effectiveness for a medical device submitted to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study report with specific acceptance criteria and performance data.

Below is an attempt to extract and infer information based on the provided text, while also explicitly stating where information is not available in the document.

Acceptance Criteria and Device Performance

Detailed Study Information:

The provided document describes the general types of testing conducted but does not provide details about a specific study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as you've requested for a device performance study. The core of a 510(k) submission for substantial equivalence is often bench testing and comparison to predicates, as opposed to a full clinical trial with "ground truth" as typically defined for diagnostic or AI-driven devices.

Here's a breakdown of the specific points you requested, with clarification on what is and isn't available:

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

   • As seen in the table above, explicit numerical acceptance criteria, specific thresholds, or detailed performance metrics from the testing (e.g., "cyclic loading withstood X cycles with Y force") are not provided in this 510(k) summary. The summary broadly states that testing showed the device "performs as well as or better than" predicates and is "safe and effective."

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

   • Not specified. The document mentions "verification and validation testing including cyclic loading characteristics, ultimate fixation strength," etc., but does not provide details on the number of samples tested for each type of bench testing, nor does it refer to clinical data or its provenance. This is typical for a device like a surgical instrument/implant in a 510(k) where substantial equivalence is often shown through engineering validation and comparison to existing devices.

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

   • Not applicable/Not specified. The "ground truth" concept, especially in the context of expert consensus, is more relevant for diagnostic devices or AI algorithms that interpret medical data. For a mechanical surgical device like the Sequent™ Meniscal Repair Device, "ground truth" would be established through objective physical measurements (e.g., force, displacement, cycles) in benchtop testing, or potentially by surgical outcomes if clinical trials were cited (which they are not in this summary). There's no mention of expert readers or consensus to establish ground truth for this type of device.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies involving human interpretation or clinical endpoints. This summary describes engineering and performance 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 device is a surgical repair device, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

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

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

   • As inferred from the "Testing" section, the "ground truth" for this device would be based on objective engineering and biomechanical measurements relevant to its function, such as:
     • Measurements of cyclic loading endurance.
     • Measurements of ultimate fixation strength.
     • Measurements of material degradation (e.g., tensile strength loss over time).
     • Functional assessments of the device's deployment mechanism.
   • The document implies that these measurements were compared against either internal specifications or the performance of predicate devices.

8. The sample size for the training set:

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

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

   • Not applicable. As above, no training set is relevant for this type of device.

In summary, the 510(k) summary for the ConMed Linvatec Sequent™ Meniscal Repair Device demonstrates substantial equivalence primarily through bench testing comparing its performance (cyclic loading, fixation strength, etc.) to legally marketed predicate devices. It does not provide the granular data or study design details for "acceptance criteria" and "ground truth" in the way one would expect for a diagnostic or AI-powered medical device. The "acceptance criteria" appear to be broadly defined by the performance of the predicate devices and general safety and effectiveness standards for such implants.

Ask a specific question about this device

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is a sterile single use device for the approximation of soft tissue such as the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) Non Absorbable Polyethylene suture (K040472), inclusive of a pre-tied knot. The distal end of the device will be offered in various angular configurations to enable access to areas of the meniscal anatomy, and to allow for user preference.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture. It describes the device, its intended use, and states that performance testing was conducted. However, it does not provide specific details about the acceptance criteria, the study design, or the results of the performance testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document only states that:

• Performance testing was conducted to verify that the Meniscal Repair Device with High Strength Suture is safe and effective and performs as intended. (Under "PERFORMANCE DATA")
• All components...are comprised of materials which are evaluated in accordance with ISO Standard 10993-1. (Under "MATERIALS")

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and materials, rather than providing detailed performance study results that would typically be associated with software or AI-driven diagnostic devices. For mechanical devices like this meniscal repair device, performance testing usually involves bench testing for mechanical properties (e.g., tensile strength, knot security) and biocompatibility testing, rather than studies involving human readers or expert consensus on diagnostic outcomes.

Ask a specific question about this device

The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries

The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device. It describes the device, its intended use, and its substantial equivalence to predicate devices based on material and performance data. However, it does not contain acceptance criteria or a detailed description of any study that proves the device meets specific performance criteria.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No acceptance criteria: The document states "Performance testing was conducted to verify that the Meniscal Repair Device is safe and effective and performs as intended," but it does not specify what those performance criteria were (e.g., tensile strength, knot security, deployment force).
• No detailed study information: While performance testing is mentioned, there are no details about the study design, sample sizes, data provenance, ground truth establishment, expert involvement, or any quantitative results.
• No direct comparison to acceptance criteria: Without specific acceptance criteria, a table showing reported device performance against those criteria cannot be created.

Therefore, most of the requested information cannot be provided based on the given document.

What can be extracted or inferred:

• Device Type: Meniscal Repair Device (surgical tool for soft tissue approximation).
• Intended Use: To approximate soft tissue, such as during the repair of meniscal tear injuries.
• Predicate Devices: Confirmed in the document (TiCron™ surgical suture, Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Stryker Mini-Mender Meniscal Repair System).
• Testing Conducted: Performance testing and material compliance testing (ISO Standard 10993-1 for biocompatibility).
• Regulatory Decision: The FDA found the device substantially equivalent to predicate devices, indicating that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.

In summary, the provided text from the 510(k) summary is a high-level overview and does not delve into the detailed technical specifications and study results required to answer your specific questions about acceptance criteria and study data.

Ask a specific question about this device

The Arthrotek® Maxfire™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The Arthrotek® Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of 2-0 Maxbraid™ ultra-high molecular weight polyethylene/polypropylene suture (Teleflex Medical, K040472) covered with two nonresorbable polyester or polyethylene sleeves. The anchors are pre-loaded on to an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. A pusher within the handle of the inserter allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the free ends of suture are gently pulled by the surgeon, drawing the loops into a flat, donut-shaped ring. This anchor sits on the backside of the meniscus. The suture is covered with either a polyester or polyethylene sleeve in order to control the size of the knot thus ensuring that the anchor does not become too small and pull through the meniscal tissue. By tensioning the suture, a sliding knot allows the meniscal tear to be compressed.

This document is a 510(k) summary for the Arthrotek® Maxfire™ Meniscal Repair Device. It details the device's description, intended use, and claims of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence." However, it does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the non-clinical data).

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

This information is not provided in the document. The testing was non-clinical laboratory testing, not human-read clinical studies.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The testing was non-clinical laboratory testing, not human-read clinical studies requiring adjudication.

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

No MRMC study was done. The document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone Performance Study:

A standalone study was done in the sense that non-clinical laboratory testing was performed on the device itself. However, this was not an "algorithm only without human-in-the loop performance" study as the device is a physical medical device, not an AI algorithm. The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

7. Type of Ground Truth Used:

The ground truth for the non-clinical testing would have been established through a set of predefined performance specifications and engineering standards for medical devices of this type (suture anchors). The results of the non-clinical laboratory tests would then be compared against these established functional and performance requirements to determine if the device was "functional within its intended use."

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device and therefore does not have a "training set" in the context of an AI algorithm.

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

This information is not applicable, as the device is a physical medical device and does not utilize a training set.

Ask a specific question about this device

The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the device is accomplished through arthroscopy or arthrotomy.

The BioStinger™-V Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from poly(Llactic acid), similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C Violet #2.

The provided document describes the BioStinger™-V Bioabsorbable Meniscal Repair Device, and its submission for 510(k) clearance based on substantial equivalence to a predicate device. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria comparing the new device against specific metrics in a clinical setting. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, and detailed study methodologies for proving device performance is not present in the provided text.

Here's an explanation of why this information is absent in the context of this specific regulatory document:

• 510(k) Submission Focus: A 510(k) (Premarket Notification) is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. The primary goal is to demonstrate that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
• No "Study Proving Acceptance Criteria" for 510(k) Equivalence: Unlike a PMA (Premarket Approval) submission, which often requires extensive clinical trials to prove efficacy and safety against specific acceptance criteria, a 510(k) typically relies on comparisons to the predicate device, including material properties, design, function, and sometimes non-clinical testing (e.g., biocompatibility, mechanical testing). The document explicitly states, "The BioStinger™-V Bioabsorbable Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec BioStinger™ Bioabsorbable Meniscal Repair Device."
• Emphasis on Predicate Comparison: The "Chart of Similarities and Dissimilarities" clearly shows that the new device and the predicate have identical intended use, material (poly L-lactic acid), sterilization, and similar design characteristics. The key difference noted for the new device is the addition of a color additive (D&C Violet #2).

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details because the provided text for the BioStinger™-V Bioabsorbable Meniscal Repair Device 510(k) submission does not contain this information.

If this were a different type of submission (e.g., a PMA or a de novo application), or if the 510(k) included specific performance data to address a new technological characteristic, such information might be present. However, for this particular document, the demonstration of safety and effectiveness relies on substantial equivalence to the predicate device.

Ask a specific question about this device

The LactoSorb® Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.

This document describes a 510(k) premarket notification for the "LactoSorb® Meniscal Repair Device". The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria that the device meets. Therefore, much of the requested information about device performance, ground truth, and expert evaluation is not explicitly available in the provided text.

Here’s a breakdown of the available information and what cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not provide specific quantitative acceptance criteria or detailed results of specific tests (e.g., tensile strength, degradation rates compared to a defined threshold). Instead, it makes a general statement of equivalency for in vitro performance and biocompatibility for in vivo 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 for Test Set: Not specified for in vitro or in vivo studies. The document only mentions "animal and clinical studies" generally.
• Data Provenance: Not specified.

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

• This information is not provided. The assessment relies on the FDA's determination of substantial equivalence, which primarily reviews the submission's claims and supporting data, not necessarily an independent expert panel for ground truth generation on a specific test set for this device.

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

• This information is not provided.

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

• This device is a meniscal repair device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not applicable and was not done.

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

• Not applicable as this is a medical device, not an algorithm.

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

• For the "in vitro testing", the ground truth would likely be established mechanical properties of predicate devices or established engineering standards.
• For the "animal and clinical studies" related to biocompatibility and resorption, the ground truth would be based on histopathological analysis, observation of tissue response, and material degradation analysis, which can be considered a form of scientific/pathological ground truth. Specific details are not given.

8. The sample size for the training set:

• This concept is not applicable in the context of this device and submission. There is no AI model or algorithm being "trained." The "animal and clinical studies" mentioned are for evaluating the material's properties and performance, not for training a model.

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

• Not applicable, as there is no training set in the context of this device.

Summary of the K982095 Submission:

This 510(k) submission for the LactoSorb® Meniscal Repair Device is a premarket notification where Biomet, Inc. sought to demonstrate that their device is "substantially equivalent" to legally marketed predicate devices. The key evidence presented for substantial equivalence involved:

• In Vitro Testing: Showing that the device performs "as well as" predicate devices in meniscal tissue approximation.
• Bioresorbable and Biocompatible Materials: Leveraging the known properties of polylactic/polyglycolic acid copolymer, which has been used in surgical procedures for years and degrades in vivo by hydrolysis. The biocompatibility was supported by existing "animal and clinical studies" (presumably prior studies on the material itself, or limited studies on this specific device, though not detailed here).

The FDA's review concluded that the device was substantially equivalent, allowing it to be marketed. The documentation does not detail specific "acceptance criteria" in the sense of predefined numerical thresholds for a specific study conducted for this submission, nor does it provide the granular data (sample sizes, expert qualifications, ground truth establishment methods) that would be expected for a detailed performance study as one might see for a diagnostic device or AI algorithm. Instead, it relies on general claims of equivalency and established material properties.

Ask a specific question about this device