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Bondek Plus Synthetic Absorbable Surgical Suture 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.

Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.

This document describes the marketing authorization for the BONDEK® PLUS Synthetic Absorbable Surgical Suture. It is a 510(k) Summary of Substantial Equivalence, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device.

Key takeaway: This device is a surgical suture, and the acceptance criteria and supporting studies will revolve around its physical properties, biocompatibility, and performance in comparison to existing sutures, rather than accuracy metrics for a diagnostic device.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing "acceptance criteria" and "reported device performance" in the context of typical diagnostic or AI device studies (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this surgical suture is based on its similarity in intended use, materials, design, and performance characteristics to predicate devices, and conformance with voluntary performance standards.

Therefore, the "acceptance criteria" are implied to be meeting the requirements of these standards and being comparable to the predicate devices. The "reported device performance" refers to the demonstration of this conformance and comparability.

• Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending))
• Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198)
• Lukens Medical Corp. Lukens® PGA suture (#K965162) |

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not mention a specific "test set" in the way one would for diagnostic device studies involving data samples. The evaluation of a surgical suture primarily involves bench testing (to meet physical standards) and biocompatibility testing (often in vitro and in vivo animal studies, or reliance on established material safety).

• Sample Size: Not specified in terms of clinical or data samples. The "data" here refers to the results of bench and biocompatibility testing required by the aforementioned standards.
• Data Provenance: Not specified. This would typically be from laboratory testing conducted by the manufacturer or accredited labs, and potentially animal studies for biocompatibility, rather than human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission for a surgical suture. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret medical images or data. For a physical device like a suture, the "ground truth" is established by adherence to recognized engineering, material science, and biological standards through objective testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods are used in studies where multiple human readers or algorithms provide interpretations that need to be reconciled for a definitive "ground truth." This is not how a surgical suture's performance or equivalence is evaluated. Its performance is measured against objective standards.

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 is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for diagnostic AI devices, not for a synthetic absorbable surgical suture.

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

This is not applicable. This question pertains to AI algorithms, which are not part of this medical device (a surgical suture).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this surgical suture, the "ground truth" is defined by:

• Voluntary Performance Standards: Such as ISO 10993-1 (biocompatibility) and U.S.P. Section 1475 (physical properties of sutures).
• Material Science and Engineering Principles: Ensuring the suture material meets specifications for strength, degradation, and handling characteristics.
• Comparability to Predicate Devices: Demonstrating that the new device performs equivalently to existing, legally marketed sutures based on their established performance profiles.

There is no "expert consensus" or "pathology" in the typical sense for establishing performance of the suture itself, although expert surgeons would evaluate its handling characteristics in practice. Outcomes data might be collected in a larger clinical trial for novel claims, but for a 510(k) for a well-understood device type, it's primarily bench and biocompatibility data.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical surgical suture, not an AI or software device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as point 8.

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The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.

The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are designed to provide a picture of the surgical field during endoscopic procedures. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras take the image that would be normally seen by the naked eye, and displays it on a color monitor. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras provide imaging through standard, commercially available, legally marketed endoscopes.

The Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras both consist of a Camera head, camera control box, and camera cable, camera cable connector soaking cap and coupler accessories. A coupler couples the camera head to the commercially available endoscope.

The provided 510(k) summary for the Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras is a premarket notification for a medical device. These documents primarily focus on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting detailed "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way a clinical trial or performance standard for algorithms would.

In this context, "acceptance criteria" would relate to regulatory compliance and equivalence to predicate devices, and the "study" would be the testing performed to demonstrate that compliance.

Here's an analysis based on the provided text, addressing your points as much as possible within the limitations of a 510(k) summary:

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

The 510(k) summary does not explicitly state acceptance criteria in terms of performance metrics (like sensitivity, specificity, resolution, etc.) for image quality or clinical utility. Instead, the acceptance criteria are implicitly that the device performs similarly to the predicate devices and meets relevant safety and electromagnetic compatibility (EMC) standards.

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

This information is not provided in the 510(k) summary. The "testing" mentioned refers to compliance with electrical safety and EMC standards, not a clinical performance study involving patient data or images. For a device like an endoscopic camera from this era, clinical performance was largely assumed by its equivalence in function and image output to existing devices.

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)

This information is not applicable and therefore not provided. The testing described (EMC and electrical safety) does not involve clinical "ground truth" established by experts.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the type of testing described here.

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 MRMC study was done. This device is a basic endoscopic camera for direct visualization, not an AI-powered image analysis tool. Therefore, discussions of "improving human readers with AI" are not relevant to this submission.

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

No standalone algorithm performance study was done. This device is hardware for image capture, not an algorithm.

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

No clinical "ground truth" was used. The testing was for compliance with electrical safety and electromagnetic compatibility standards.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is an imaging hardware component, not an AI algorithm requiring a training set.

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

This information is not applicable and therefore not provided. As per point 8, there is no AI algorithm or training set discussed in this 510(k).

In summary of the 510(k) context:

This 510(k) notification is primarily focused on demonstrating that the new endoscopic camera is substantially equivalent to legally marketed predicate devices. This means showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The "performance testing" referred to (EN 55011 & EN 60601-1-2) relates to electrical safety and electromagnetic compatibility, which are standard engineering tests for medical devices, rather than clinical efficacy studies often associated with AI or novel diagnostic tools. Therefore, many of the questions you asked, which are highly relevant for AI/algorithm-based devices, are not applicable to this type of medical device submission.

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Bondek Synthetic Absorbable Surgical Suture 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.

Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.

This document is a 510(k) summary for the Bondek® Synthetic Absorbable Surgical Suture. It establishes substantial equivalence to previously marketed devices and outlines the indications for use and device description. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

This type of information is typically found in submissions for devices that involve diagnostic or AI components, where performance is measured against a ground truth. For sutures, the "performance" is generally related to material properties, biological compatibility, and mechanical strength, which are assessed through conformance to standards (e.g., USP, ISO 10993-1) as mentioned in the document. The document states:

"The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"."

This indicates that the "acceptance criteria" were compliance with these established standards, and the "study" was the performance testing conducted to demonstrate this compliance. However, the specific data from these tests is not provided in this summary.

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The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand.
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.

The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.

The provided document is a 510(k) summary for a surgical instrument holder called SAPHLIFT. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than performance studies with defined acceptance criteria.

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The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.

The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.

The provided text is a 510(k) summary for the "Rapid Transfer Blood Bag," a medical device. This document focuses on the regulatory submission process and the intended use of the device, rather than detailed performance studies or specific acceptance criteria with reported data.

Therefore, the document does not contain the information requested to comprehensively fill out the table regarding acceptance criteria and study details.

Here's a breakdown of what can be extracted and why other sections cannot be completed:

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

• Cannot be filled. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., blood transfer rate, efficiency, mechanical strength, sterility, biocompatibility data from specific tests). It's a regulatory submission summarizing the device and its intended use, rather than a detailed study report.

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

• Cannot be filled. The document does not describe any specific testing, test set sample sizes, or data provenance.

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. This question pertains to studies involving expert review for ground truth establishment, typically for diagnostic or image-based devices. The Rapid Transfer Blood Bag is a device for fluid transfer, and its evaluation would not typically involve expert consensus on "ground truth" in this manner.

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

• Not applicable. See point 3.

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 not an AI/diagnostic software, so MRMC studies are irrelevant.

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

• Not applicable. This device is not an algorithm or AI.

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

• Not applicable. See point 3.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model that requires a training set.

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

• Not applicable. See point 8.

In summary, the provided document is a regulatory affairs submission (510(k) summary and FDA letter) focused on demonstrating substantial equivalence to predicate devices, rather than a detailed technical study report containing performance data and acceptance criteria.

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The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.

The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible shaft, and tip. The Handle includes two knobs that control the orientation and position of the tip. The proximal knob tightens the cable that adjusts the tip between 0 and 90 degrees. The distal knob rotates the tip between 0 and 360 degrees.

The provided document describes a 510(k) premarket notification for the Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle. This type of submission is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic algorithm would.

The document primarily focuses on establishing "substantial equivalence" based on operational and technological characteristics. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as performance metrics with thresholds (e.g., accuracy > 90%). The "acceptance criteria" for a 510(k) submission like this are essentially demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness.
• Reported Device Performance: The document provides a comparison of characteristics between the proposed device and predicate devices. This isn't "performance" in the statistical sense, but rather a functional comparison.

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

This information is not applicable to this 510(k) submission. There is no "test set" in the context of evaluating a diagnostic algorithm's performance. The submission relies on comparative analysis with predicate devices and descriptive information.

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)

This information is not applicable. There is no "ground truth" establishment in the context of a performance study for this type of mechanical surgical instrument.

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

This information is 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

This information is not applicable. This device is a surgical instrument, not an AI or diagnostic tool designed to assist human readers.

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

This information is not applicable. This device is a surgical instrument, not an algorithm.

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

This information is not applicable.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of mechanical surgical instrument.

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

This information is not applicable.

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"Cutalon" Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

"Cutalon" Nonabsorbable Polyamide Surgical Sutures are composed of the long-chain aliphatic polymers extruded Nylon (Nylon 6) sutures which conform to the United States Code of Federal Regulations, 21 CFR Part, 878.5020. "Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon. Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5).

This document describes the Genzyme "Cutalon" Nonabsorbable Polyamide Surgical Suture, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a novel device evaluation.

Below is an analysis structured to address your points, acknowledging that much of the information requested (like detailed performance studies, expert involvement, and statistical sample sizes for training/test sets) is not applicable or present for a 510(k) submission based on substantial equivalence to an already marketed device.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The "Cutalon" Nonabsorbable Polyamide Surgical Suture does not present a novel technology requiring de novo performance studies against specific acceptance criteria. Instead, its acceptance is based on demonstrating substantial equivalence to a predicate device (Genzyme's existing Nylon Suture) that has already met regulatory requirements. The key "acceptance criteria" here are aligning with existing standards and demonstrating no new questions of safety or effectiveness.

The "study" proving the device meets these criteria is primarily a comparison analysis and biocompatibility testing, rather than a clinical trial or performance study against quantitative metrics like accuracy, sensitivity, or specificity.

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)

For substantial equivalence submissions like this, dedicated "test sets" with statistically determined sample sizes for performance evaluation (e.g., accuracy against a gold standard) are not typically required or provided.

• Biocompatibility Testing: The specific sample sizes for tests like USP Muscle Implant, Sensitization, Acute Systemic Toxicity, Hemocompatibility, Cytotoxicity, and Genotoxicity are not explicitly stated in the summary. These tests typically involve animal models or in-vitro cultures. The provenance would be the testing laboratories, likely in the US, following recognized standards (ISO 10993-1). These are prospective tests performed on the "Cutalon" device.
• Comparison to Predicate: The "test set" in this context is the predicate device itself and its historical performance, which has been marketed since December 1976.

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)

This is not applicable. No "ground truth" in the clinical sense (e.g., disease diagnosis) needed to be established by experts for comparing performance. The "ground truth" for this submission revolves around:

• USP standards: These are established by pharmacopeial experts.
• Biocompatibility standards (ISO 10993-1): These are established international standards by experts in toxicology and materials.
• Predicate device characteristics: These were established during the original market approval (PMA N85-060 in 1976 and subsequent 510(k) K930738 in 1994) and are accepted as given.

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

Not applicable. There was no "adjudication" of performance data from a test set in this context. The FDA's review process itself involves regulatory experts evaluating the submission against established regulations and guidance documents.

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 a medical device (suture), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-assisted performance metrics are irrelevant.

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

Not applicable, as this is not an AI algorithm.

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

The "ground truth" for this 510(k) submission is primarily derived from:

• Regulatory Standards: United States Code of Federal Regulations (21 CFR Part 878.5020 for Nylon sutures).
• Pharmacopeial Standards: United States Pharmacopeia (USP) requirements for nonabsorbable sutures.
• International Biocompatibility Standards: ISO 10993-1 Biological Evaluation of Medical Devices.
• Predicate Device Data: The established safety and effectiveness profile of Genzyme's existing Nylon Suture that has been on the market since 1976, which served as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

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

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