Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The MANI Needle & Suture Pack (PGA Absorbable) 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 (PGA Absorbable) consists of a stainless steel needle and PGA Absorbable suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

The provided text is a 510(k) summary for a medical device called the "MANI Needle and Suture Pack (PGA Absorbable)". This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

It does not contain information about specific acceptance criteria and a study proving those criteria are met in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot extract the information required for the table and subsequent questions from the provided text. The document acts as a regulatory submission, not a detailed clinical or performance study report.

Ask a specific question about this device

The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.

The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) consists of a stainless steel needle and poly(ethylene terephthalate) suture, for use in short term tissue approximation, including use in ophthalmic surgery.

The provided text is a 510(k) summary for the MANI Needle and Suture Pack. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided document.

Ask a specific question about this device