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The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.

SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle.

They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them:

Note: The provided document describes a "Substantially Equivalent" (SE) determination, which focuses on comparing a new device to an existing legally marketed device (predicate device). This is different from a de novo premarket review where novel performance criteria might be established. Therefore, the "acceptance criteria" here largely refer to demonstrating comparable performance to the predicate device and compliance with relevant standards. The "study" is primarily a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many eye spears were tested for absorbency, or how many units for sterility). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

Data Provenance: The tests were conducted by the manufacturer, Huizhou Foryou Medical Devices Co., Ltd. located in China. The data would be considered prospective for the purpose of demonstrating the specified characteristics for this device submission.

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

This information is not applicable to this type of 510(k) submission. "Ground truth" established by experts is typically relevant for studies involving diagnosis, image interpretation, or clinical decision-making. This submission deals with the physical and biological properties of a medical device (eye spear). The acceptance criteria are based on established international and national standards (ISO, ASTM, USP, BS EN) and comparison to a predicate device, rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

Not applicable. As the tests are non-clinical and objective (e.g., measuring absorbency, cytotoxicity), there is no "adjudication method" in the sense of resolving discrepancies between human interpretations of clinical data. The results would be objectively measured and compared against the defined standard or specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiology interpretation). This 510(k) pertains to a non-diagnostic, single-use medical device (an eye spear) and does not involve AI or human interpretation in its intended use.

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

No. This device is a physical medical instrument, not a software algorithm or an AI-powered system, so the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this device is the objective measurement against established industry and regulatory standards, and comparison to the characteristics of the predicate device.

• For biocompatibility: Adherence to ISO 10993 standards.
• For physical properties (absorbency, particulate release, etc.): Measurement against specific test methods (e.g., BS EN 13726-1, USP ) and demonstration of comparable performance to the predicate device.
• For sterility: Achieving a defined SAL and passing endotoxin tests.
• For packaging: Passing specified ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model, so there is no "training set" in the context of data used for algorithm development.

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

Not applicable. As there is no training set for this device, this question is not relevant.

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Network Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field.

Network Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field.

Network Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.

Network Eve Spears, Points, Drains, Wicks and Shields are single devices designed for tissue manipulation, fluid management and shielding of light in ophthalmic surgery. Spears and points consist of a triangle of dry Polyvinyl Alcohol (formalized) Sponge (PVA) or Cellulose sponge, either attached to a polypropylene handle for handling or separate to be picked up by forceps. The triangular shape allows the surgeon to carry out pinpoint absorption of liguid. Drains and Wicks are PVA Sponges in various sizes and shapes for wicking of fluid away from the operative field. Shields are circular-shaped PVA Sponges that moisten the cornea and reduce the light intensity on the retina during surgery.

This submission, K130117, focuses on demonstrating substantial equivalence for the Network Eye Spears, Points, Wicks, Drains and Shields to existing predicate devices. It does not contain information about a study with acceptance criteria in the typical sense of measuring device performance against specific targets for diagnostic accuracy or clinical outcomes. Instead, the "acceptance criteria" are based on meeting established safety and performance benchmarks through non-clinical testing, primarily biocompatibility, sterility, and shelf-life, to show equivalence to legally marketed predicates.

Here's a breakdown of the requested information based on the provided text, with many points being "Not Applicable" (N/A) due to the nature of the device and the submission type:

Acceptance Criteria and Device Performance

This submission demonstrates substantial equivalence to predicate devices rather than proving performance against specific numerical acceptance criteria for a novel diagnostic or therapeutic effect. The "acceptance criteria" are the successful completion of non-clinical tests aligning with regulatory standards and showing comparability to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. This submission relies on non-clinical laboratory testing and comparison to predicate devices, not a clinical "test set" of patient data. The sample sizes for biocompatibility, sterility validation, and accelerated aging tests would be determined by relevant ISO standards, but specific numbers are not provided in the summary.
   • Data Provenance: Not applicable in the context of patient data. The tests were performed by Network Medical Products, Ltd. as described in the submission.

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

   • Not applicable. There was no "ground truth" established by experts for a clinical test set in this submission; the evaluation criteria are defined by recognized standards (ISO 10993, ISO 11137, Blue Book Memo G95-1) for device safety and performance.

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

   • Not applicable. There was no clinical "test set" requiring adjudication.

4. 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 manual surgical tool (sponges, wicks, shields) and does not involve AI or human readers for interpretation.

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

   • Not applicable. This device is a manual surgical tool and does not involve algorithms.

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

   • Not applicable in the context of clinical ground truth. The "ground truth" for demonstrating equivalence is based on established regulatory standards and the known safety and performance of already-marketed predicate devices. For biocompatibility, laboratory assay results are the "truth." For sterility, established SAL is the "truth." For materials, the chemical composition and physical properties are the "truth."

7. The sample size for the training set:

   • Not applicable. This submission does not involve a "training set" as it's not an AI/machine learning device. The "training" for the manufacturing process would be part of the quality system, but no specific data points are provided here.

8. How the ground truth for the training set was established:

   • Not applicable.

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AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the AlphaMed™ Surgical Spear, and it primarily focuses on regulatory approval and substantial equivalence to a predicate device.

The document does not contain details about:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Types of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a regulatory communication, not a scientific study report.

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The Cenefom PVA Surgical Spear is indicated for short-term transient use in ophthalmic surgical procedures for absorbing excess fluids from the operative field.

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The provided FDA document (K082460) is a 510(k) clearance letter for the Longtek Cenefom PVA Surgical Spear and does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.

This document solely focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• The device's regulation number, name, and regulatory class.
• General controls and other regulations that apply to the device.
• The indications for use for the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or AI performance, as this document does not pertain to those aspects.

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Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate.

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The provided text is a 510(k) clearance letter from the FDA for the "Ultracell Absorbent Stick." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory approval document confirming substantial equivalence to a predicate device, not a technical report detailing performance studies.

Therefore, I cannot provide the requested information based on the input text.

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The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.

The M-Pact Corneal Light Shield is designed to be placed on the surface of the cornea during ophthalmic procedures to shield the retina from excessive illumination. The Corneal Light Shield is transient to minimal short-term use only. The Shield is nonabrasive, and is formulated to resist tearing or shedding of fibers.

This document does not contain an acceptance criteria table or a study proving that the device meets specific acceptance criteria.

Instead, this is a 510(k) summary notification for a medical device called the "M-Pact Corneal Light Shield." The document focuses on demonstrating substantial equivalence to a predicate device (Merocel Corneal Sponge), rather than proving performance against defined acceptance criteria through a specific study.

The "Substantial Equivalence Table" in the document lists features of the M-Pact Corneal Light Shield and the predicate device, showing that they share similar technological characteristics. This is a comparison of design and material properties, not a performance study against acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.

Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron.
Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge.
Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery. Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton.
Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.

The provided text focuses on the summary of safety and effectiveness for several medical devices (Corneal Light Shield, Instrument Wipes, Surgical Spears and Sponges, Fluid Wicks) and their FDA 510(k) clearance. It does not contain information on acceptance criteria for a device, nor does it describe a study proving the device meets specific acceptance criteria using the detailed points requested in your prompt.

Specifically, the document discusses:

• Historical context and problem statement: The need for corneal protection during ophthalmic surgery due to light-induced retinal damage.
• Device description: Materials and sterilization methods for the Hurricane Medical products.
• Predicate device comparison: The 510(k) clearance process implicitly relies on substantial equivalence to predicate devices, but the technical details of how current devices meet specific performance metrics are not described.
• FDA Clearance: The letter from the FDA confirms the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text. This document is a regulatory summary for device clearance, not a detailed study report.

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