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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.

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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.

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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.

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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.

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