(141 days)
The MANI Needle & Suture Pack (Silk) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
The MANI Needle & Suture Pack (Silk) consists of a stainless steel needle and silk suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
This document is a 510(k) summary for a medical device called the "MANI Needle and Suture Pack (Silk)". It's a regulatory submission to the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving device performance as requested.
The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing performance metrics from a dedicated clinical or analytical study.
Here's an analysis of what information could be extracted or inferred based on the provided text, and what information is explicitly missing:
Missing Information:
The provided text does not contain any of the requested information regarding specific acceptance criteria for performance or details of a study (clinical or analytical) to prove those criteria are met. This document is a regulatory summary for a 510(k) submission, which aims to demonstrate "substantial equivalence" to a predicate device, as opposed to proving novel clinical endpoints or detailed performance characteristics with a dedicated study.
Explanation Based on the Document Type:
510(k) submissions, like this one, typically rely on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device that is already legally on the market. This often involves:
- Comparison to Predicate Device: The document clearly states the predicate device: "Alcon Laboratories Needles and Sutures, 510(k) # 760158." The conclusion states, "MANI, Inc. believes that the MANI Needle & Suture Pack (Silk) is substantially equivalent to its claimed predicates under conditions of intended use." This comparison is the primary "proof" for a 510(k).
- Intended Use Statement: The "Indications for Use" section outlines what the device is for ("short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue"). The substantial equivalence argument means that if the predicate device is safe and effective for this use, and the new device is substantially similar, then the new device is also considered safe and effective for the same use.
Therefore, the questions you've asked about acceptance criteria, study details, sample sizes, experts, ground truth, and specific performance metrics are not typically found in this type of 510(k) summary unless a specific performance test was required to establish substantial equivalence for a particular attribute.
The document implies that the device "meets the acceptance criteria" in the sense that the FDA found it substantially equivalent to its predicate, which is the regulatory "acceptance criterion" for a 510(k) clearance. However, this is not performance acceptance criteria as would be found in a clinical trial or engineering performance verification.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.