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POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.

This document describes the Polyester Surgical Suture, a nonabsorbable, sterile suture composed of Poly (ethylene terephthalate), intended for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Tri-Cron® Non-Absorbable Polyester Surgical Suture and Ethibond® Nonabsorbable Polyester Surgical Suture) through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the POLYESTER surgical suture are primarily based on conformance to United States Pharmacopeia (U.S.P.) standards and demonstrating substantial equivalence to the predicate devices. The document explicitly states that the device meets these requirements.

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

The document states: "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device."

• Sample Size: The specific sample sizes for the non-clinical tests are not provided in this summary.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's non-clinical testing for a device intended for U.S. market (submitted to FDA), it's highly likely the testing was conducted in a controlled laboratory environment, potentially in the U.S. or by a compliant international facility.

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

This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through expert consensus on qualitative assessments.

4. Adjudication Method for the Test Set

This section is not applicable as the ground truth for this device is established through non-clinical, objective measurements against U.S.P. standards, not through human adjudication of qualitative data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device relies on demonstrating substantial equivalence to already approved predicate devices through non-clinical testing.

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

This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI model.

7. The Type of Ground Truth Used

The ground truth used for evaluating the POLYESTER surgical suture is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. This involves objective physical and functional property measurements (e.g., suture diameter, length, knot pull tensile strength, needle attachment strength).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.

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

This question is not applicable as the device is a physical surgical suture and does not involve AI or machine learning models that require training sets.

In summary, the Polyester Surgical Suture demonstrated conformance to U.S.P. standards and substantial equivalence to predicate devices through non-clinical laboratory testing of its physical and functional properties. No clinical studies, expert-based ground truth, or AI-related evaluations were performed or required for this 510(k) submission.

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The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances.

Limb Holders (protective restraints) Foam Limb Holder w/Quick Release Buckle Proprietary Names: Polvester Pile Wrist/Ankle Restraint Soft Flannel Wrist/Ankle Restraint Wrist Restraint, Universal

The provided text is a 510(k) summary for Zimmer Limb Holders (protective restraints) from 1996. It details the device's intended use, classification, and comparison to existing legally marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.

The document discusses:

• Safety and Effectiveness: It states that the Zimmer line of restraints has been manufactured and in commercial distribution for over 20 years and are exempt from 510(k) premarket notification procedures and Good Manufacturing Practice Regulations.
• Intended Use: To prevent restless, confused, elderly, or unsteady patients from injuring themselves or clinical personnel.
• Regulatory Context: It mentions Health Care Financing Administration Regulations and Joint Commission on Accreditation of Healthcare Organizations standards related to restraint use, emphasizing appropriate supervision and least restrictive restraint.
• Problems: States that the most significant problems with restraints are attributed to misuse or misapplication, not design or materials.

Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on regulatory classification and existing market presence rather than a detailed performance study with specific acceptance criteria.

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The polyester nonabsorbable surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck. The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck's Ti-cron* is dyed blue (D&C Blue #6).

Here's an analysis of the provided text regarding acceptance criteria and device performance:

This document describes a 510(k) submission for a medical device, but it fundamentally lacks the detailed information required to answer most of your detailed questions about AI device performance and studies. The device described is a Polyester Nonabsorbable Surgical Suture, which is a physical, non-AI medical device. The document predates the widespread use of AI in medical imaging and diagnostics, and thus, its content is focused on traditional medical device equivalency rather than AI performance.

Therefore, the following answers are based on the limited information provided for a non-AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Additional Note: The document states the R.K. Medical sutures are "equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck" in terms of the above parameters.

Regarding the remaining questions on AI device studies:

The provided document does not contain any information about an AI-powered device, image analysis, diagnostic algorithms, or any type of study that would involve:

• AI performance metrics (sensitivity, specificity, AUC)
• Sample sizes for test or training sets for an AI model
• Data provenance for AI input data
• Experts establishing ground truth for AI analysis
• Adjudication methods for AI
• Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance
• Standalone (algorithm-only) AI performance studies
• Types of ground truth for AI (pathology, outcomes)
• Training set details for AI algorithms

Therefore, it is impossible to provide answers to questions 2 through 9 based on the given text. This document is for a physical surgical suture, not an AI device.

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