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The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.

Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II.

The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the E-PACK™ Procedure Kit. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document pertains to a procedure kit consisting of pre-packaged existing medical devices (sutures, clips, etc.) and its packaging design and sterilization, not an AI/ML-driven medical device or a diagnostic device whose performance is measured via metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information regarding acceptance criteria and study designs relevant to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, I can extract the information that is relevant to the device described:

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

The document describes performance testing related to product integrity and manufacturing processes, not diagnostic performance. The "acceptance criteria" here relate to meeting existing standards for medical device components and packaging.

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

The document does not specify exact sample sizes for each test (e.g., number of kits tested for stability or transit). It states that testing was "performed," and the results "provide reasonable assurance." The data provenance is internal design verification testing performed by Ethicon, Inc.

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

This is not applicable. The product is a pre-packaged kit of existing devices, and the "testing" relates to physical characteristics, sterility, and packaging integrity, not diagnostic or clinical accuracy requiring expert interpretation of ground truth.

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

Not applicable.

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 is not an AI/ML device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" here is defined by compliance with established international standards (e.g., ISO 10993-7 for biocompatibility, ISO 11607-1 for packaging, ISO 14971 for risk management) and the confirmed performance of the individual components within the kit, which were already legally marketed and had their own established safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

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Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.

Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a 510(k) submission for an absorbable surgical gut suture and details its intended use, characteristics, materials, and performance data, but it does not specify acceptance criteria, study results in the format of a table, sample sizes for test or training sets, data provenance, expert qualifications, or details about MRMC studies. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study against specific acceptance criteria.

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Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".

Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

The provided document is a 510(k) summary for the Demetech Absorbable Surgical Gut Suture (Plain and Chromic), demonstrating substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), expert involvement, and ground truth establishment is not applicable in this context.

However, I can extract the relevant information from the document to address the aspects that are present:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here refers to meeting the performance requirements defined by the United States Pharmacopeia (USP) for absorbable surgical sutures, specifically USP 23 and the current edition USP 24. The reported device performance is that Demetech's suture "meets or exceeds" these requirements.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of data in the context of AI/ML. The performance testing is likely conducted on batches of manufactured sutures. The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture performance is established by standardized physical tests, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used:
The ground truth used for evaluating the Demetech suture is standardized physical tests against the requirements of the United States Pharmacopeia (USP 23 and USP 24). This includes:

• General performance requirements for "Absorbable Surgical Suture"
• Specific requirements for "Diameter" ()
• Specific requirements for "Tensile Strength" ()
• Specific requirements for "Needle Attachment" ()
• Specific requirements for "Finish suture Length Requirement" (95% of stated label length)

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established: Not applicable.

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UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (surgical sutures) and does not contain any information about acceptance criteria, study details, or performance data for an AI/ML device. Therefore, I cannot generate the requested table and accompanying details based on the given input.

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MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.

The provided text describes a 510(k) premarket notification for a medical device, MONOCRYL* Plus Antibacterial Suture. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through clinical trials with defined acceptance criteria and extensive performance studies as might be described in a PMA (Premarket Approval) application.

Therefore, many of the requested details, such as specific acceptance criteria for numerical performance metrics, sample sizes for test sets to establish ground truth, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or not explicitly provided in this type of submission document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices. This means the new device must be as safe and effective as a legally marketed device and share similar technological characteristics and indications for use.
  • Specifically, for performance, the device had to conform to the USP Monograph for absorbable surgical sutures (except for diameter) and perform as intended and claimed in in-vivo/in-vitro testing.
• Reported Device Performance:
  • "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures."
  • "Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed."

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

• Not explicitly stated. The document mentions "non-clinical laboratory testing" and "in-vivo/in-vitro testing" but does not provide specific sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or included in a 510(k) summary.

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

• Not applicable. This submission doesn't involve subjective interpretations or diagnoses that would require expert-established ground truth in the way clinical diagnostic devices do. The testing described (USP monograph compliance, in-vivo/in-vitro performance) relies on objective measurement standards.

4. Adjudication method for the test set

• Not applicable. As there's no expert-established ground truth in this context, no adjudication method would be used.

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 suture, not a diagnostic imaging device or an AI-powered system that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This is a physical medical device (suture) and does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on objective, standardized measurements against the USP Monograph for absorbable surgical sutures and general biological/mechanical performance evaluations (in-vivo/in-vitro testing) to ensure it performs as intended and claimed. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner of diagnostic devices.

8. The sample size for the training set

• Not applicable. The device is a physical suture, not a software algorithm requiring a training set.

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

• Not applicable. (See point 8).

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The AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.

The AUTOBAHN Tissue Closure Device is a non-sterile, reusable device for use with the AUTOBAHN Disposable Cartridge. The AUTOBAHN Disposable Cartridge is a sterile; single-use disposable cartridge containing a standard type needle and standard, absorbable and non-absorbable, suture that is attached to the reusable AUTOBAHN Tissue Closure Device. The AUTOAHN Tissue Closure Device and Disposable Cartridge are indicated for soft tissue approximation and/ or ligation in general surgical procedures. The needle is contained within the AUTOBAHN Disposable Cartridge before, during, and after the case, aiding in the prevention of suture needle sticks to the surgeons, nurses, and OR staff. The AUTOBAHN tissue Closure Device needle is driven around inside the cartridge in a complete 360° arc. A completed stitch is placed each time the needle and suture are driven across the aperture and through tissue located within the aperture.

The provided text is a 510(k) Premarket Notification for a medical device (AUTOBAHN Tissue Closure Device and Disposable Cartridge). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text primarily describes:

• Device Description and Intended Use: The AUTOBAHN Tissue Closure Device and Disposable Cartridge are for soft tissue approximation and/or ligation in general surgical procedures, designed to prevent needle sticks.
• Predicate Device: FASTCLOSE Fascia Closure Device (K01105).
• Technological Characteristics: Stated as "identical" to the predicate device.
• FDA Communication: A letter from the FDA confirming substantial equivalence to the predicate device based on the submitted information.

To directly answer your specific points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) focuses on substantial equivalence based on technological characteristics and intended use being identical to a predicate device, not on specific performance metrics or acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no dedicated performance study is described.
4. Adjudication method for the test set: Not applicable, as no dedicated performance study 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 closure device, 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 physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no dedicated performance study is described. Substantial equivalence for this device relies on demonstrated technological similarity and safety/effectiveness of the predicate device.
8. The sample size for the training set: Not applicable, as no algorithm or training set is described.
9. How the ground truth for the training set was established: Not applicable, as no algorithm or training set is described.

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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.

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SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Not Found

The provided text is an FDA 510(k) clearance letter for a medical device (SERRALGut™ Suture). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It does not include the technical details of performance testing or clinical studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested information is not present in the document.

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Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Grams Absorbable Surgical Gut Suture (Plain and Chromic):

This document describes a 510(k) premarket notification for a medical device (surgical suture), not an AI/ML device. Therefore, many of the requested categories related to AI/ML specific studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable. The device's "performance" is based on conformity to established physical and chemical standards for surgical sutures.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and 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 explicitly stated. The document refers to "performance testing data" but does not give specific numbers of sutures tested.
• Data Provenance: Not specified, but implied to be from a manufacturing and testing process adhering to USP standards. Given the applicant's address (Grafton, Wisconsin, USA), it's highly likely the testing was conducted in the USA or by a facility adhering to US regulations. The testing methodology would be prospective based on current manufacturing batches.

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. The "ground truth" for suture performance is established by objective, standardized physical and chemical tests defined in the United States Pharmacopeia (USP Monograph). This does not involve expert consensus in the way an AI diagnostic tool would.
• Qualifications of Experts: Not applicable for establishing ground truth; however, the testing would be performed by qualified laboratory personnel following USP protocols.

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

• Adjudication Method: Not applicable. The performance is based on objective measurements against USP standards, not subjective assessment requiring adjudication.

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

• MRMC Study: No. This is a traditional medical device (suture), not an AI/ML device.

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

• Standalone Study: Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and chemical characteristics of the suture itself.

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

• Type of Ground Truth: The ground truth is defined by objective, standardized measurements against the specifications and test methods outlined in the United States Pharmacopeia (USP 23 and USP 24) for "Absorbable Surgical Suture", "Diameter" , "Tensile Strength" , "Needle Attachment" , and "Finish suture Length Requirement".

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device. The "training" for a physical device is its manufacturing process and quality control, which is implicitly ongoing.

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

• How Ground Truth for Training Set was Established: Not applicable. For a manufactured product like a suture, ongoing quality control and adherence to manufacturing specifications ensure consistency. The "ground truth" for the manufacturing process is its ability to consistently produce sutures that meet the USP standards, which are verified through the performance testing mentioned in the document.

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