(33 days)
For Vascular Work: Suitable for veins and arteries. Performs efficiently on either diseased or normal vessels. Provides occlusion of atherosclerotic vessels without excessive closing forces. Minimizes intimal damage and fragmentation of atherosclerotic material. Can be clamped over indwelling catheters. For Gastrointestinal Work: Replaces bulky, rubber shod clamps. Cushion-design of inserts enables occlusion without crushing the bowel.
Slimline Surgical Clamp and Slimline Jaw Inserts
The provided text is related to a 510(k) submission for a medical device: the "SlimLine Surgical Clamp and SlimLine Jaw Inserts." This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a study proving performance against acceptance criteria in the manner one might expect for a novel AI/software medical device.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this document. The 510(k) summary focuses on comparing the new device to existing predicate devices based on intended use, principles of operation, and basic technological characteristics, rather than detailed performance metrics from a clinical study.
Here's an assessment based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a study. Instead, it asserts substantial equivalence based on:
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use | Equivalent to predicate devices (vascular/general surgery) |
| Principles of Operation | Equivalent to predicate devices (squeezing jaws for occlusion) |
| Basic Technological Characteristics | Equivalent to predicate devices |
| Target Population | Equivalent to predicate devices (surgical disciplines) |
| Safety & Effectiveness | Claimed equivalent to predicate devices |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document is not describing a study with a test set of data in the context of an algorithm or diagnostic performance. It's a regulatory submission for a physical medical device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: No. This is a physical surgical clamp, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the context of an AI/diagnostic study. The "ground truth" for this 510(k) is the established performance and safety of the legally marketed predicate devices (Allegiance Healthcare's Fogarty Surgical Clamp and Baxter International's Safejaw Inserts). The claim is that the new device performs similarly.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary based on the 510(k) document:
The provided document is a 510(k) Pre-Market Notification for a surgical clamp. Its purpose is to demonstrate "substantial equivalence" of the new device (Slimline Surgical Clamp and Slimline Jaw Inserts) to legally marketed predicate devices. This type of submission relies on comparing intended use, basic technology, and principles of operation to existing devices, and often provides performance data through bench testing or literature review rather than a formal clinical study with performance metrics (like sensitivity/specificity) against a ground truth.
The document states: "Minumys' Slimline Surgical Clamp with Slimline Jaw Inserts and Allegiance's Fogarty Surgical Clamp with Baxter's Safejaw Inserts are surgical clamps intended for use in vascular or general surgery. The Slimline Surgical Clamp and Slimline Jaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines."
The "study" in this context is the submission demonstrating that the device aligns with the predicate devices' characteristics, and by extension, is safe and effective for its stated indications for use. No clinical trial data, performance metrics, or AI-specific study details are present in this 510(k) summary.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).