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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.

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

The ACE™ 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, circular row of titanium 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. The stapler may be introduced over a guidewire. If multiple plications are required, an endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The guidewire, 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.

The BaroSense ACE Stapler and Cartridge underwent bench and animal testing to establish safety and effectiveness. The device's biological evaluation also conforms to ISO 10993-1:2009 for biocompatibility, ISO 11137-1:2006 for sterilization of healthcare products - radiation - Part 1, and ISO 11137-2:2006 for sterilization of healthcare products - radiation - Part 2. The report explicitly states that for each of these ISO standards, the test data demonstrated conformity and the standards themselves include acceptance criteria.

Here's a breakdown of the specific aspects you requested, based on the provided text:

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)

The document mentions "a series of bench and animal tests" but does not specify the sample sizes for these tests. The country of origin for the data, whether it was retrospective or prospective, is also not provided in the given text.

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)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation mainly references compliance with recognized international standards (ISO) and general "bench and animal tests."

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

The document does not describe any adjudication method for test sets.

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

There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study being performed, nor is there any mention of AI assistance or human reader improvement with AI in the provided text. This device is a surgical stapler, not an AI-powered diagnostic tool.

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

This question is not applicable. The BaroSense ACE Stapler is a medical device, not an algorithm or AI system. Its performance is inherent to its mechanical and material properties, and its functionality is directly operated by a human user (surgeon) with a flexible endoscope for visualization.

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

For biocompatibility and sterilization, the "ground truth" is adherence to the specifications and requirements defined within the referenced ISO standards (ISO 10993, ISO 11137-1, ISO 11137-2). For general safety and effectiveness, the document generally refers to "acceptable results" from bench and animal tests. No specific expert consensus, pathology, or outcomes data is detailed as the direct ground truth apart from the standards themselves.

8. The sample size for the training set

This question is not applicable as the device is a mechanical surgical stapler and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the same reason as point 8.

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