Search Results

The Suturtek 360° Sternal Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needle stick injuries.

The SuturTek 360° Sternal Closure Device™ is a an instrument that is used to pass stainless steel needles through sternum for fixation with stainless steel sutures. It is used to hold and close the sternum after a sternotomy.

The device is sterilized before each use. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the tissue. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are placed in the same manner and then the ends of the suture are tied together in the usual fashion.

The provided document is a 510(k) Summary of Safety and Effectiveness for the SuturTek 360° Sternal Closure Device™. This submission process seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a standalone study with ground truth establishment and expert adjudication.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of device performance evaluation.

Instead, the submission relied on demonstrating equivalence to the predicate device, the SuturTek FASTCLOSE™ Sternum Closure Device™ (K032468).

The document states:

• "Documentation was provided which demonstrated that the SuturTek 360° Sternal Closure Device™ is substantially equivalent to the predicate device, the SuturTek FASTCLOSE™ Sternum Closure Device™ K032468"

This type of submission focuses on comparing the new device's design, materials, and intended use to a device already cleared by the FDA, rather than conducting a de novo study to establish performance metrics against a defined standard.

Ask a specific question about this device

The SuturTek Surgical Steel Suture is intended for use in sternal closure.

The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.

The provided text describes a 510(k) summary for a surgical steel suture and does not contain detailed information about acceptance criteria, device performance, or a study proving its conformance beyond general bench testing. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

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

• Acceptance Criteria: Not explicitly stated. The document mentions "Bench testing was performed to demonstrate that the SuturTek Surgical Steel Suture would perform as intended." without listing specific performance metrics or thresholds.
• Reported Device Performance: Not explicitly stated. The document indicates that bench testing was performed and implies successful performance ("would perform as intended"), but no quantitative results are provided.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not mentioned.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. It's bench testing, so "country of origin" of data wouldn't typically apply in the same way as clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as the testing described is bench testing, not a clinical study involving expert interpretation or ground truth establishment in a diagnostic sense.

4. Adjudication method for the test set

• Not applicable as the testing described is bench testing.

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

• No, a MRMC comparative effectiveness study was not done. The device is a surgical suture, not an AI or imaging diagnostic device.

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

• Not applicable. The device is a surgical suture, not an algorithm.

7. The type of ground truth used

• Not applicable in the conventional sense. For bench testing of a physical device, the "ground truth" would be the engineering specifications and performance standards against which the device is tested. These specifics are not detailed in the provided text.

8. The sample size for the training set

• Not applicable, as this is 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, as this is a physical medical device.

Summary of available information:

• Study Type: Bench testing.
• Purpose of Study: To demonstrate that the SuturTek Surgical Steel Suture would perform as intended.
• Conclusion of Study (implied): The bench testing was successful, as the FDA granted 510(k) clearance based on substantial equivalence.
• Device Intended Use: For use in sternal closure during thoracic surgery.
• Comparison Basis: Substantial equivalence to predicate devices (Aesculap: Steelex Sternum Set; K023411 and CP Medical: Surgical Steel Monofilament Stainless Steel; K030351). The operating principle, materials, intended use, and design of construction are stated to be the same as predicate devices.

Missing Information (critical for your request): Detailed acceptance criteria, specific performance results, sample sizes, and expert involvement (as the study was bench testing).

Ask a specific question about this device

The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.

The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.

The provided text describes a 510(k) premarket notification for the SuturTek FASTCLOSE Sternum Closure Device. It details the device, its intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or the other requested information for the device's performance.

Based on the provided information, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: The document only states "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended." No specific performance metrics or results are provided.

2. Sample sized used for the test set and the data provenance

• This information is not provided in the document. The document mentions "Bench testing," but no details on sample size or data provenance are included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. Bench testing typically does not involve expert-established ground truth in the same way clinical studies or image-based AI studies do.

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

• This information is not provided in the document. Adjudication methods are typically relevant for human review of data, which is not described for this device's testing.

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

• This information is not provided in the document. The device is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.

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

• This information is not provided in the document. The device is a manual instrument, so "standalone" performance in the context of an algorithm is not applicable.

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

• This information is not provided in the document. For bench testing of a surgical device, ground truth would likely refer to engineering specifications or mechanical performance metrics, but these are not detailed.

8. The sample size for the training set

• This information is not provided in the document. The device is a physical instrument, so a "training set" in the context of machine learning is not applicable.

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

• This information is not provided in the document. As above, a "training set" is not relevant for this type of device.

Summary Table of Available Information:

General Conclusion:

The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence to predicate devices and describes the device's design and intended use. It confirms that "Bench testing was performed to demonstrate that the FASTCLOSE Sternum Closure Device would perform as intended," but it does not include the detailed performance data, acceptance criteria, or study methodologies that would be required to answer most of your specific questions. This level of detail is often found in the full 510(k) submission, but not typically in the publicly available summary.

Ask a specific question about this device

The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.

The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.

It is designed to aid in the prevention of suture needle stick injuries.

The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.

The provided text describes a 510(k) premarket notification for the SuturTek FASTCLOSE™ Suturing Device. The submission focuses on demonstrating substantial equivalence to a previously marketed device (K011105) and highlights an added "Sharps Injury Prevention Feature Claims."

However, the document does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML device. The provided text describes a medical device (suturing device) and its premarket notification, which is a different type of submission than what would typically include AI/ML performance data.

Here's a breakdown of why the requested information cannot be extracted from the given text:

1. AI/ML Device: The SuturTek FASTCLOSE™ Suturing Device is a manual instrument, not an AI/ML powered device. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," "MRMC comparative effectiveness study," or "standalone algorithm performance" as they relate to AI/ML devices are not applicable or discussed in this document.

2. Acceptance Criteria and Device Performance: The document states that "Tests applicable to the type of safety device and safety features of the FASTCLOSE Device per the FDA Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps Injury Prevention Features' (March 1995) were: Simulated Use Testing." However, it does not provide:

   • Specific quantitative acceptance criteria (e.g., "sharps injury reduction rate of X%").
   • The reported device performance against those criteria (e.g., "achieved Y% reduction").
   • Any details about the methodology, sample size, or results of the "Simulated Use Testing."

3. Ground Truth, Experts, Adjudication: These terms are relevant for evaluating diagnostic or predictive AI/ML models where there's a need to establish a definitive correct answer (ground truth) often through expert consensus. For a mechanical surgical device with a sharps injury prevention feature, the "ground truth" would likely be the actual occurrence or non-occurrence of a sharps injury during simulated use, and typically wouldn't involve expert adjudication in the same way an image interpretation task would. No such details are present.

In summary, the provided document is a 510(k) summary for a mechanical surgical device and does not contain the specific information you've requested regarding acceptance criteria and performance studies in the context of an AI/ML device.

To illustrate, if this were an AI/ML device, the detailed information about acceptance criteria and study results would typically be found in a "Performance Testing" section that provides quantitative metrics (e.g., sensitivity, specificity, AUC) and a thorough description of the study design. This document does not include such a section.

Ask a specific question about this device