Search Results

The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

The ACETM Stapler is a surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract. The single-patient-use, disposable stapler head is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. The stapler head is attached to a reusable, flexible stapler handle that controls the position and articulation of the stapler head. In use, the stapler is introduced into the patient through the mouth. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication (tissue fold) in the GI tract, which is then compressed. The stapler then places a double ring of titanium staples (8 staples). A non-absorbable ring helps reinforce the staple placement in the tissue. The tissue compression and stapling functions are controlled by commercially available inflation syringes. An endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The overtube, flexible endoscope, vacuum pump and inflation syringes used with the stapler are all commercially available medical devices, not the subject of this 510(k), and are not supplied with the stapler.

This document describes the BaroSense ACE™ Stapler and Cartridge, a surgical stapler used for staple closure on the wall of the stomach or gastrointestinal tract. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary for a medical device seeking substantial equivalence to a previously cleared predicate device.

Here's a breakdown of why the requested information is absent and what is provided:

Missing Information (and why it's missing from this type of document):

• A table of acceptance criteria and the reported device performance: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on detailing specific performance acceptance criteria and results. Such criteria and results would typically be found in detailed test reports, not in this high-level summary.
• Sample size used for the test set and the data provenance: Clinical study details are not typically provided in this type of 510(k) summary for a device seeking substantial equivalence based on bench and animal testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no human-read test set is described.
• Adjudication method for the test set: Not applicable as no human-read test set is described.
• 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 is a surgical stapler, not an AI-assisted diagnostic or imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical stapler.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no human-read test set is described. Performance is based on physical and mechanical testing.
• The sample size for the training set: Not applicable. This is a surgical stapler, not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "acceptance criteria" and "study":

The document states:

• "All patient-contacting components of the ACE Stapler are composed of materials of known biocompatibility and tested to the requirements of ISO 10993 for the predicate device." This implies that biocompatibility is an acceptance criterion, and testing to ISO 10993 is the study demonstrating it.
• "The only new material for the modified device is a white orientation marking on the flexible portion of the stapler handle. The new material has also been tested to the requirements of ISO 10993." This reinforces biocompatibility testing as an acceptance criterion for new materials.
• "The safety and effectiveness of the device was further established through a series of bench and animal tests. All testing yielded acceptable results." This is a general statement that safety and effectiveness were verified through bench and animal studies, and the results were acceptable. It does not provide specific performance metrics or acceptance criteria beyond "acceptable results."

Summary of available information:

• Safety and Effectiveness: Established through bench and animal tests. (Specific performance metrics and acceptance criteria for these tests are not detailed beyond "All testing yielded acceptable results.")
• Substantial Equivalence: The primary "acceptance criteria" for K120147, as a 510(k), is substantial equivalence to the predicate device K110829 by demonstrating similar technological characteristics and indications for use, despite minor modifications (staple pattern, stapler head diameter, stapler handle diameter, longer articulation section). This is not a performance criterion in the typical sense, but rather a regulatory one. |
  | Sample size (test set) & Data Provenance | Not specified for bench or animal tests. Data provenance is implied to be from BaroSense, Inc.'s internal testing. |
  | Number of experts & qualifications for ground truth (test set) | Not applicable. No expert-based ground truth for a test set is described. Tests are physical/mechanical. |
  | Adjudication method for test set | Not applicable. |
  | MRMC comparative effectiveness study | Not applicable. This is a surgical stapler, not an AI/imaging device. |
  | Standalone (algorithm only) performance study | Not applicable. This is a surgical stapler. |
  | Type of ground truth used | Not applicable in the context of human expert review. Performance is assessed against engineering specifications, biocompatibility standards (ISO 10993), and functional performance in bench and animal models (though specific metrics not detailed in this summary). |
  | Sample size for training set | Not applicable. This is a surgical stapler, not an AI/ML device. |
  | How ground truth for training set was established | Not applicable. |

In essence, the document serves as a regulatory summary to demonstrate substantial equivalence, not a detailed technical report on performance testing and acceptance criteria. It mentions "bench and animal tests" yielded "acceptable results" to establish safety and effectiveness, and new materials were "tested to the requirements of ISO 10993" for biocompatibility, but it does not elaborate on the specific acceptance criteria or the study details.

Ask a specific question about this device