(113 days)
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hemia repairs.
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is a 5mm laparoscopic device for hernia repair. It is a multi-fire, single-use device pre-loaded with 25 absorbable straps. The straps are composed of a blend of polydioxanone and L(-)-lactide and glycolide dyed with D&C Violet No. 2.
The provided text describes a 510(k) summary for the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device. This is a submission to demonstrate substantial equivalence to a predicate device, not necessarily a study proving acceptance criteria for a novel device's performance in a clinical setting. Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory document.
However, I will extract the information that is available and indicate where information is not provided.
1. A table of acceptance criteria and the reported device performance
The document states that the new device is "substantially equivalent" to the predicate device. For 510(k) submissions, the acceptance criteria are generally that the new device performs "as intended" and is "substantially equivalent" to the predicate device in terms of safety and effectiveness, based on comparison with the predicate and performance data. Specific numerical acceptance criteria are not typically detailed in the public 510(k) summary for devices like this.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Same intended use as predicate device (fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repair). |
| Indications for Use | Similar indications for use as predicate device. |
| Technological Characteristics | Similar technological characteristics and principles of operation as predicate device. Minor technological differences raise no new issues of safety or effectiveness. |
| Material Biocompatibility | Materials used have been evaluated in accordance with ISO 10993-1:2003 and are equivalent to the predicate device. |
| Overall Safety & Effectiveness | "Fulfills the device requirements as defined in used specifications, functions as intended, and is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench and animal" testing as part of the performance data.
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin). The testing type ("bench and animal") indicates prospective data generation for the purpose of this submission, rather than retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable for this 510(k) submission. The evaluation is based on engineering performance, material compatibility, and comparison to a predicate device, not on expert-adjudicated clinical ground truth from a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of regulatory submission. There is no mention of human adjudication of results in the context of clinical outcomes or diagnostic accuracy.
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
Not applicable. This device is a surgical fixation device, not an AI-assisted diagnostic tool or imaging system. Therefore, an MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for demonstrating substantial equivalence would be based on:
- Engineering specifications and functional testing results.
- Comparison to the established performance characteristics and safety profile of the predicate device.
- Biocompatibility testing against ISO standards.
- Animal study results (though specifics are not provided).
There is no mention of expert consensus, pathology, or specific clinical outcomes data as "ground truth" in this summary, which primarily focuses on bench and animal testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML 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.