(35 days)
The Salute® II Disposable Fixation Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.
The Salute II Disposable Fixation Device consists of a handle, shaft/shaft tip and comes preloaded with 316L stainless steel wire. The device is used to deliver permanently implanted Q-shaped constructs (Q-Rings). Depending on user preference, the device is offered in an 18cm shaft preloaded with either 10 or 30 Q-Rings and a 38cm shaft (fits into a 5mm trocar) preloaded with either 10, 30, or 60 Q-Rings.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Salute II Disposable Fixation Device:
Crucially, the provided document is a 510(k) Summary and FDA clearance letter, not a detailed study report. Therefore, it focuses on demonstrating equivalence to a predicate device rather than presenting a comprehensive study with specific acceptance criteria, statistical power calculations, or detailed performance metrics. As a result, many of the requested items cannot be fully extracted or are explicitly stated as "Not Applicable" or "Not Provided."
Acceptance Criteria and Device Performance
The document does not explicitly present a table of numerical acceptance criteria or a direct comparison to specific reported device performance values in the way one might expect from a detailed clinical or performance study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device through:
- Same intended use: The Salute II Disposable Fixation Device has the same intended use as the predicate device (fixation of prosthetic material and approximation of tissue in surgical procedures).
- Similar technological characteristics: Both devices place stainless steel wire into tissue/prosthetics to fixate prosthetics/approximate tissue using a handle and shaft to deliver 316L stainless steel Q-shaped constructs.
- Equivalent performance: Bench testing demonstrated the proposed product "delivers the same shape and comparably sized Q-rings, which provides equivalent fixation."
Therefore, the "acceptance criteria" here are less about numerical thresholds for sensitivity/specificity and more about establishing functional and safety equivalence to a legally marketed predicate device.
Table of Implicit Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device is indicated for use in a variety of laparoscopic/endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue. | Met: The Salute II has the same stated Intended Use as the predicate device (Salute Stapler and Staples). |
| Technological Equivalence - Q-Ring Placement: Designed to place stainless steel wire into tissue/prosthetics to fixate prosthetics/approximate tissue, delivering permanently implanted, 316L stainless steel Q-shaped constructs (Q-rings) via a handle and shaft. | Met: The Salute II performs this function with the same Q-ring material and design principle. |
| Functional Equivalence - Q-Ring Characteristics: Delivers Q-rings of the same shape and comparable size as the predicate device. | Met: "Based on bench testing, the Proposed Product delivers the same shape and comparably sized Q-rings..." |
| Functional Equivalence - Fixation Performance: Provides equivalent fixation to the predicate device. | Met: "...which provides equivalent fixation." |
| Safety - Biocompatibility: The device materials (especially the permanently implanted components and those in contact with tissue) must be biocompatible. | Met (Prospective): "In addition, biocompatibility will be completed and passed before the Proposed Product is launched." (This indicates completion post-submission but pre-launch, and is a standard requirement for such devices). |
| Safety - New Features: New features (distal tip rotation, end of construct indication, handle lock-out) must not introduce new safety concerns and should function as intended. (This is implied as part of the overall safety assessment for predicate equivalence). | Met (Implied): New features were added as "user conveniences" based on market and user feedback, and the overall determination is safe and effective. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not provided. The performance data is based on "bench testing" which implies mechanical or functional tests in a laboratory setting, not human subject data.
- Data Provenance: Bench testing data, conducted by Davol, Inc. (submitter). Location of testing not specified, but typically conducted in-house by the manufacturer. Prospective, as it was conducted for the purpose of this submission. Since it's bench testing, country of origin related to patient data is not applicable.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this relies on bench testing of physical characteristics (shape, size, fixation strength), expert review of patient data ground truth is not relevant. The "ground truth" for bench testing would be objective measurements and engineering specifications.
-
Adjudication method for the test set:
- Not applicable. No human interpretation of complex medical data requiring adjudication.
-
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. This is a medical device for surgical fixation, not an AI/imaging diagnostic device. MRMC studies are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual surgical fixation device, not an algorithm.
-
The type of ground truth used:
- For bench testing: Engineering measurements, physical specifications, and comparative performance against the predicate device in terms of Q-ring shape, size, and fixation equivalence.
-
The sample size for the training set:
- Not applicable. This is a physical device, not an AI algorithm requiring a training set. If "training set" refers to design iterations or prototypes, that information is not provided.
-
How the ground truth for the training set was established:
- Not applicable. Same as above.
§ 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.