Search Results

The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use: AUTOTRANSFUSION 1) for the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations CHEST DRAINAGE - 1) to evacuate air and/or fluid from the chest cavity or mediastrinum - 2) to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum - 3) to help re-establish and maintain normal intrathoracic pressure gradients - 4) to facilitate complete lung re-expansion to restore normal breathing dynamic.

The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a multi-chamber collection/reinfusion system. The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a sterile, single use devices intended for the collection of autologous blood (autotransfusion) and as chest drainage collection units.

The provided text describes a 510(k) submission for the Pleur-evac® Sahara Plus Continuous Reinfusion Autotransfusion System. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment relevant to the request.

The document confirms that this device is "substantially equivalent" to a previously marketed device (K963850) based on "a detailed device description, performance testing and conformance with consensus and voluntary performance standards." However, the details of these performance tests, including specific acceptance criteria and study results, are not elaborated upon in the provided sections.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them because the necessary details are absent from the provided text.

Ask a specific question about this device

Monodek™ Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Monodek Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture is a sterile, monofilament and is provided in a variety of lengths, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.

The provided text describes a 510(k) summary for the Monodek™ Synthetic Absorbable Surgical Suture, which focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance (beyond meeting USP requirements for sutures except for oversized diameter)
• Sample sizes for a test set or data provenance for such a test
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth for a test set
• Sample size for a training set
• How ground truth for a training set was established

The information provided focuses on regulatory equivalence:

Acceptance Criteria for Substantial Equivalence:

The primary "acceptance criteria" for the device, as presented, are based on demonstrating substantial equivalence to predicate devices and conformance with established standards and guidance documents. These implicitly act as the performance benchmarks.

Study Proving Acceptance Criteria:

The "study" used to demonstrate that the device meets these acceptance criteria is a regulatory submission based on comparison to predicate devices and adherence to established standards.

• Study Type: This is not a clinical trial or a performance study in the typical sense of a novel device proving its efficacy or accuracy against specific clinical endpoints. Instead, it is a 510(k) premarket notification demonstrating substantial equivalence to legally marketed predicate devices.
• Methodology: The determination of substantial equivalence was based on:
  • A detailed device description.
  • Performance testing (implied by meeting USP requirements, though specific test results or protocols are not detailed in this summary).
  • Conformance with voluntary performance standards (ANSI/AAMI/ISO 10993-1, USP Section XXV).
  • Adherence to FDA guidance documents ("Guidance for Surgical Suture 510(k)s" and "Class II Special Controls Guidance Document: Surgical Sutures").

Missing Information (as per your requested categories):

The document does not describe any specific studies that would involve:

• Sample sizes for a test set (as there wasn't a separate "test set" in the context of an AI device)
• Data provenance
• Number of experts or their qualifications for ground truth in a performance study
• Adjudication method
• MRMC comparative effectiveness study or effect size (as this is a physical medical device, not an AI diagnostic tool)
• Standalone performance (not applicable for this type of device)
• Type of ground truth (e.g., pathology, outcomes data) for a diagnostic performance study
• Sample size for a training set
• How ground truth for a training set was established

In summary, for this specific medical device (a surgical suture), the "acceptance criteria" are met by demonstrating broad equivalence to existing, approved products and adherence to industry standards and regulations, rather than through a performance study that measures accuracy or efficacy against a defined ground truth in a test and training set, which would be typical for AI/diagnostic devices.

Ask a specific question about this device

The Tissue Retractor System is intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.

The RadLite™ Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.

The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and maintain a cavity by retracting the subcutaneous layer to expose the conduit. The retraction is sufficient to allow enough exposure to dissect and retract subcutaneous tissue for performing all types of surgical procedures. This system consists of the following components:

• Handle: The handle securely holds the retractor blade, light panel, and provides a host adaptor for ACMI connection to a variety of commercially available light sources.
• Retractor/blade: The stainless steel retractor blade attaches to the handle for lifting the subcutaneous layer.
• Fiber Optic Light Panel: The light panel fits securely into the handle on the underside of the retractor blade to provide illumination for the procedure.

The provided document, K022989, is a 510(k) Summary of Safety and Effectiveness for the "Tissue Retractor System" from Genzyme Biosurgery. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information regarding acceptance criteria or a study proving device performance against such criteria.

The document primarily covers:

• Manufacturer Information: Genzyme Biosurgery
• Device Identification: Tradename (Tissue Retractor System), Classification (Endoscopic Instruments and Accessories per 21 CFR §876.1500), Common Name (Tissue Retractor).
• Predicate Devices: SaphLITE® System (K960400) by Genzyme Biosurgery and ENDOPATH® Ultra-Retractor (K973139) by Ethicon Endo-Surgery, Inc.
• Device Description: Components (Handle, Retractor/blade, Fiber Optic Light Panel) and function (creating and maintaining a cavity by retracting the subcutaneous layer).
• Intended Use: Dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.
• Comparison of Characteristics: States "The technological characteristics of the New Device are the same as the predicate devices."
• Conclusion of Substantial Equivalence: Based on detailed device description, conformance to consensus standards, and voluntary standards.
• FDA Response Letter: Confirms substantial equivalence and outlines regulatory responsibilities.
• Indications for Use: Reiterates the intended use in extraperitoneal spaces and for tissue retraction in all types of surgical procedures.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance studies because this information is not present in the provided text. The 510(k) pathway often relies on demonstrating equivalence to existing legally marketed devices rather than conducting extensive performance studies against specific acceptance criteria for a novel technology that would require such detailed reporting.

Ask a specific question about this device

The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Saph-LOOP is the addition of a means for deployment of a length of Tevdek™ suture with a pre-tied knot for ligation of conduit in minimally invasive and general procedures, particularly conduit harvesting procedures. The deployment device consists of a long tube carier with an offset tip at the distal end, a handle and a pull ring at the proximal end.

The provided text is a 510(k) summary for the Saph-Loop™ Ligating Loop, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information cannot be extracted directly from this document.

Here's an analysis based on the available information:

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

This information is not provided in the document. 510(k) summaries for devices like sutures often rely on comparison to a predicate and adherence to recognized standards, rather than defining specific performance metrics and acceptance thresholds for a new clinical study. The device is a variation of an existing suture with a new deployment mechanism.

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. As this is a 510(k) for a modified device, the submission primarily focuses on technical comparison to the predicate device and conformance to standards, not a new clinical study with a test set.

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/provided. No "ground truth" or expert consensus for a test set is mentioned, as there isn't a new clinical study described in this summary.

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

This information is not applicable/provided. There is no description of a test set or adjudication process in the summary.

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. The Saph-Loop™ Ligating Loop is a surgical device, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable. See point 5.

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

This information is not applicable/provided. No new ground truth data is established or discussed in this 510(k) summary. The "ground truth" for this submission is substantial equivalence to the predicate device, demonstrated through descriptive comparison and adherence to standards.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device and submission type.

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

This information is not applicable/provided. See point 8.

Summary of what is known from the document regarding meeting acceptance criteria (substantive equivalence):

The device gained 510(k) clearance by demonstrating substantial equivalence to the predicate device, the Tevdek® II suture (K001440).

The basis for this substantial equivalence included:

• A detailed device description of the Saph-Loop™ Ligating Loop.
• The Saph-Loop™ uses the same suture material (Tevdek™) as the predicate.
• The difference lies in the addition of a deployment mechanism (carrier tubing, handle, pull ring) for the pre-tied knot.
• Conformance to consensus standards and voluntary standards (though specific standards are not listed in this summary).

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates that the submitted evidence was sufficient for the FDA to determine that the Saph-Loop™ Ligating Loop met the acceptance criteria for a 510(k) clearance based on substantial equivalence.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device