(21 days)
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair
Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.
Here's an analysis of the provided text regarding the Absorbatack™ Absorbable Fixation Device. It appears this documentation describes a 510(k) submission for a medical device and not a study demonstrating the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the US. It does not contain information on a study with acceptance criteria and reported device performance in the context of, for example, diagnostic accuracy or treatment efficacy.
Therefore, many of the requested sections about study design, sample size, ground truth, and expert evaluation are not applicable in this context.
Analysis of Absorbatack™ Absorbable Fixation Device (K091900)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A) - This document does not specify performance-based acceptance criteria in the way a clinical or algorithm performance study would. The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a predicate device. | Substantially Equivalent to the predicate device (Absorbatack™ Absorbable Fixation Device, K071920). The device is identical in design, materials, and intended use. |
Explanation: In a 510(k) pathway, the "acceptance criteria" are typically regulatory requirements for demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing identical technological characteristics, intended use, and materials, or by conducting performance testing to demonstrate equivalence if there are differences. This document explicitly states "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device." Therefore, no new performance data comparing it against specific quantitative acceptance criteria is presented for this particular submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set (in the context of clinical or algorithm performance evaluation) is described.
- Data Provenance: Not applicable. The document relies on the identical nature of the device to its predicate, rather than new performance data from a specific test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. No such study is described or referenced.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not applicable. This device is a physical surgical tack, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The ground for this submission is the established safety and effectiveness of the predicate device (K071920) through its prior clearance, and the assertion that the current device is identical.
8. Sample Size for the Training Set
- Sample Size: Not applicable. As this device is not an algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable.
Summary of the Document's Content:
The provided documents detail a 510(k) premarket notification for the "Absorbatack™ Absorbable Fixation Device." The core of this submission is the claim that the device is substantially equivalent to a previously cleared predicate device (K071920), also named "Absorbatack™ Absorbable Fixation Device."
Key points from the submission:
- Identity to Predicate: The submitter explicitly states: "Absorbatack™ Absorbable Fixation Device is identical to the predicate device" and "There has been no change to the Absorbatack ™ Absorbable Fixation Device."
- Materials Evaluation: The materials were evaluated according to ISO 10993-1: 2003, "Biological Evaluation of medical devices - Part I Evaluation and Testing," and again, stated to be identical to the predicate device.
- Performance Data: The document states, "The modified labeling for the subject device is based on performance testing obtained for the predicate device." This indicates that no new performance testing for the subject device itself was conducted for this specific 510(k) submission; rather, it leveraged the existing data from the identical predicate.
- Intended Use: Fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures (e.g., hernia repair), which is consistent with the predicate.
In essence, this is a regulatory filing asserting that a device, which remains unchanged from a previously cleared version, is still substantially equivalent to that predicate. Therefore, it bypasses the need for new, extensive performance studies with specific acceptance criteria that would typically be seen for a novel device or a device with significant modifications.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.