(141 days)
The MANI Needle & Suture Pack (Nylon) 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 (Nylon) consists of a stainless steel needle and Nylon 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 the MANI Needle and Suture Pack (Nylon), a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving it:
This document does not contain the information you are requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria."
This 510(k) submission is a declaration of substantial equivalence to an already legally marketed device (a predicate device). For this type of submission, the manufacturer typically demonstrates that their new device is as safe and effective as the predicate device by showing it has the same intended use, technological characteristics, and performs similarly through direct comparison, not by conducting new clinical studies or defining new acceptance criteria for the device.
Therefore, I cannot populate your table or answer the specific questions because the provided text does not include:
- A table of acceptance criteria and reported device performance.
- Details of a study proving the device meets acceptance criteria.
- Information about sample sizes for test sets or training sets.
- Data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- Description of the type of ground truth used.
Instead, the document focuses on:
- Device Description: What the MANI Needle and Suture Pack (Nylon) is made of (stainless steel needle and Nylon suture).
- Intended Use: For short-term soft tissue approximation, including ophthalmic surgery, but not for cardiovascular and neurological tissue.
- Predicate Device: Alcon Laboratories, Surgical Suture, 510(k) # 930517.
- Conclusion: The device is substantially equivalent to its claimed predicates under conditions of intended use.
- FDA Clearance: The FDA letter confirms the device is substantially equivalent and can be marketed.
In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device, and the "study" is often a comparison of technical specifications and performance data (which is not detailed here beyond the claim of equivalence) rather than a novel clinical trial with pre-defined acceptance metrics.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.