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The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.

The subject device is designed to deliver fixation springs via a minimally invasive sterile disposable instrument that is for single patient use. The fixation springs are made of nitinol and are composed of 3 coils that are approximately .18 inches in diameter. The spring is held within the lumen of a needle is inserted through the tissue or prosthetic material to be approximated or fixated and the spring is pushed out so that approximately 1 coil of the spring is released. The needle is then withdrawn from the tissue or prosthetic material while the remainder of the spring is pushed out thereby deploying at least one coil on the proximal surface of the tissue or prosthetic material. Because the spring is manufactured such that the coils are naturally pre-compressed against each other, the distal and proximal coils place a compression force on the tissue or prosthetic material that holds them together.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details.

The document is a 510(k) summary for a medical device (Coil Fixation Device) and focuses on describing the device, its intended use, and claiming substantial equivalence to a predicate device. It does not include the detailed study results or performance metrics you requested.

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The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).

A single-use, surgical instrument for placing stainless steel sutures.

The provided text is related to a 510(k) submission for the Manual Touché Suturing System. However, it does not contain information about acceptance criteria, device performance testing, or study details (like sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

The document primarily focuses on:

• Identifying the device (Manual Touché Suturing System).
• Claiming substantial equivalence to predicate devices (Powered Touché Suturing System and Salute Fixation System).
• Describing the subject device and comparing its technical aspects to predicate devices.
• Stating its intended use and indications.
• Providing the FDA's clearance letter for the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information on the study design elements you asked for. The document does not describe the specific testing or studies conducted to prove the device meets performance criteria.

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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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The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.

The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.

This document, K010620, is a 510(k) summary for the Salute staple removal instrument. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

• No Acceptance Criteria or Performance Data: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by comparing technical aspects and intended use. It does not present specific quantitative acceptance criteria (e.g., a specific success rate or precision/recall metric) or the results of a study designed to meet such criteria. It's likely that performance was demonstrated through bench testing and a comparison to the predicate device, rather than a formal clinical trial with defined acceptance criteria for a new AI/software device.
• Device Type: This device is an "Endoscopic Staple Removal Instrument," which is a physical, reusable surgical instrument, not an AI or software-based diagnostic device. Therefore, many of your questions, such as those related to AI algorithm performance (standalone, MRMC, training sets, ground truth for AI), are not applicable to this physical medical device.

Let's break down what can be answered based on the provided text, and why other questions cannot be:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or provide a table of reported device performance against such criteria. The basis for clearance is "substantial equivalence" to a predicate device, meaning its safety and effectiveness are considered comparable based on its design and intended use, not necessarily by meeting pre-defined quantitative performance metrics in a clinical trial.

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

• Not applicable/Not provided. As a physical instrument, a "test set" in the context of AI data is not relevant. The document does not describe any formal clinical or pre-clinical studies with a "sample size" in the way an AI/software device would have. Testing would typically involve bench testing (e.g., staple removal efficacy, durability, sterilization effectiveness) rather than a data-based test set from patients.

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/Not provided. This question relates to establishing ground truth for AI models, which is not relevant for this physical device.

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

• Not applicable/Not provided. This question is for AI/software device performance evaluation.

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/Not provided. This question is for AI/software device performance evaluation. The device is a surgical instrument.

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

• Not applicable/Not provided. This question is for AI/software device performance evaluation.

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

• Not applicable/Not provided. This question is for AI/software device performance evaluation.

8. The sample size for the training set

• Not applicable/Not provided. This question is for AI/software device development.

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

• Not applicable/Not provided. This question is for AI/software device development.

In summary: The provided 510(k) summary for the "Endoscopic Staple Removal Instrument" is for a physical medical device. It demonstrates substantial equivalence to a predicate device based on similar design, materials (implicitly), and intended use. The questions you've asked are largely tailored to the evaluation of AI or software-as-a-medical-device (SaMD), which operates on a different regulatory and evaluative framework.

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