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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:

Study Details

1. 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.

2. 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.

3. Adjudication method for the test set:

   • Not applicable. No human interpretation of complex medical data requiring adjudication.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. Same as above.

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The Salute® Fixation System 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 Fixation System consists of a reusable handle, shaft and shaft tip, as well as a sterile, disposable implant cartridge with wire survey ube and cover. The disposable implant cartridge comes prektades from 316L stainless steel wire. The device is used to deliver permanently maginn on Q-shaped rings (Q-ring). Depending on user preference, the handle may be used with an 18cm shaft or a 38cm shaft (fits into a 5mm trocal). Implant cartridges are offered with sufficient 316L stainless steel wire to form 10, 20, 30, or 50 Q-rings and are designed to work with either a 38cm shaft or an 18cm shaft. The handle and shaft are engraved with serial numbers, which must match in order for the device to function properly. The Instructions for Use (IFU) contain information to insure the implant cartridge is used with an appropriate shaft and to confir:: serial numbers of the shaft/handle match.

The provided documentation describes a premarket notification for the Salute® Fixation System (SFS). However, the document does NOT contain information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures.

The "Performance Data" section (G.) in the K050610 document on page 2/2 primarily discusses:

• Biocompatibility: Stating that biocompatibility testing will be completed and passed before a new PTFE material is released. This refers to material safety, not clinical performance metrics.
• Bench Testing: Stating that "Bench testing on the Proposed demonstrated the Q-ring shape and dimensions were substantially equivalent to the Predicate." This indicates equivalency in physical characteristics, not clinical effectiveness or performance against specific criteria.

Therefore, the requested information elements cannot be fully extracted from the provided text for a device performance study as typically understood in the context of AI/medical device performance evaluation.

However, I can extract and present the type of "performance data" that was provided, which is focused on substantial equivalence rather than traditional performance metrics and acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified. The document refers to "Bench testing," which implies physical tests on the device itself, not patient data.
• Data Provenance: Not applicable, as no human data or clinical study is described for performance evaluation.

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. Performance was assessed through bench testing and comparison to a predicate device, not by expert review of clinical cases.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. There was no test set requiring human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This device is a manual surgical fixation system, not an algorithm or AI.

7. The type of ground truth used:

• Ground Truth: The "ground truth" was the characteristics and performance of the predicate device (Salute Stapler and Staples by Onux Medical, Inc.) and the results of bench testing for physical properties (Q-ring shape, dimensions, etc.) and biocompatibility standards.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. This document does not describe an AI/ML device or a training set.

9. How the ground truth for the training set was established:

• Ground Truth (Training Set): Not applicable.

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The Salute Fixation System is indicated for use in a variety of laparoscopic / endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

A minor modification has been made to the Salute staples in that a coating has been added to the surface of the staples. A reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs. This instrument may be used laparoscopically with 5mm trocars.

This 510(k) premarket notification for K014286 describes a minor modification to an existing Endoscopic stapler and staple system (Salute Fixation System) by adding a coating to the surface of the staples.

Crucially, the provided document does NOT contain specific acceptance criteria, performance data, or detailed study information required to populate most of the requested fields. This submission relies on substantial equivalence to predicate devices (ProTack™ laparoscopic stapler and Ethicon staples) which also use a similar coating.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned.

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)

• Not applicable as no specific test set or ground truth establishment process is described for this submission. The submission relies on equivalence to existing devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no specific test set or adjudication process is described.

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 stapler, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a surgical stapler, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable as no specific ground truth for performance evaluation is described. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that the established safety and effectiveness of those predicates extend to this modified device.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

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