(97 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical targets or benchmarks for specific performance metrics. The document states that the device "performs as well as or better than the legally marketed predicate devices." | The device was determined to be "safe and effective and performs as well as or better than the legally marketed predicate devices." |
| Cyclic loading characteristics | Testing included cyclic loading characteristics. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported. |
| Ultimate fixation strength of meniscal repairs | Testing included ultimate fixation strength. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported. |
| Functional system testing | Testing included functional system testing. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported. |
| Material degradation | Testing included material degradation. The implication is that the performance met internal benchmarks or was comparable/superior to predicate devices, though specific values are not reported. |
| Risk analysis | A risk analysis was conducted. The implication is that risks were adequately identified and mitigated. |
| Packaging/transportation qualification | Packaging/transportation qualification was conducted. The implication is that the packaging and transportation methods adequately protect the device. |
| Substantial Equivalence to Predicate Devices | The device is "substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics" to predicate devices (Meniscal Cinch™ K073149 and Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems K072322). Minor differences "do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use." |
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:
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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."
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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.
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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.
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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.
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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.
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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.
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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.
- 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:
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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.
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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.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.