(30 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.
The ReliaTack ™ Articulating Reloadable Fixation Device is a reloadable sterile, single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. The device is offered as a stand-alone reloadable handle prepackaged with three 10 standard purchase tack single use reloads. The reloads and handle that are packaged together are designed to be used together.
The ReliaTack ™ Articulating Reloadable Fixation Device can accommodate
10 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks
5 standard purchase tack reloads with 5.1mm long absorbable PGLA tacks
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical "acceptance criteria" for each performance test. Instead, it describes "performance evaluations... to show ReliaTack™... is substantially equivalent to the predicate device and perform as intended." The reported device performance is implicitly that it meets the standard of substantial equivalence for these tests as compared to the predicate.
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Trigger Firing Force | Substantially equivalent to the predicate device (AbsorbaTack™ Absorbable Fixation Device K123109) in terms of trigger firing force. | The ReliaTack™ device was shown to be substantially equivalent to the predicate device with regard to Trigger firing force. |
| Shaft Side Load | Substantially equivalent to the predicate device (AbsorbaTack™ Absorbable Fixation Device K123109) in terms of shaft side load. | The ReliaTack™ device was shown to be substantially equivalent to the predicate device with regard to shaft side load. |
| Media Shear Force | Substantially equivalent to the predicate device (AbsorbaTack™ Absorbable Fixation Device K123109) in terms of media shear force. | The ReliaTack™ device was shown to be substantially equivalent to the predicate device with regard to media shear force. |
| Safety Lock-Out Test | Demonstrates effective safety lock-out mechanism. | Test performed, and results indicated substantial equivalence. (Specific performance details not provided, but implies successful function) |
| Tissue trauma (in vivo, patient) | Demonstrates acceptable levels of tissue trauma for the patient during use. | Test performed, and results indicated substantial equivalence. (Specific performance details not provided, but implies acceptable levels) |
| Tissue trauma (in vivo, user) | Demonstrates acceptable levels of tissue trauma for the user during operation. | Test performed, and results indicated substantial equivalence. (Specific performance details not provided, but implies acceptable levels) |
| Biocompatibility | All components of ReliaTack™ are comprised of materials which are in accordance with ISO Standard 10993-1. | All components of ReliaTack™ are comprised of materials which are in accordance with ISO Standard 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual performance test (e.g., number of devices tested for trigger firing force, number of in-vivo experiments). It generally refers to "performance evaluations."
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, however, the tests listed (in vitro and in vivo) are typically prospective by nature for a pre-market evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The study is focused on bench and in-vivo animal testing (implied by "in vivo" and lack of human clinical trials mentioned), not on human interpretation or diagnosis, which would typically involve expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials. This submission focuses on engineering performance and biocompatibility.
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in medical imaging or diagnostic contexts. The ReliaTack™ device is a surgical fixation device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The ReliaTack™ is a mechanical surgical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering measurements, physical properties, and biological responses (for biocompatibility and in-vivo tissue trauma). For equivalence claims, the ground truth is often established by adherence to recognized standards (e.g., ISO 10993-1 for biocompatibility) and direct comparison to the performance characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set
Not Applicable. As this is a mechanical medical device and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. There is no training set for this device.
§ 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.