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

Not Found

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.

Not Found

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.

Not Found

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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Ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea.

The Ophthalmic Solutions, LLC, The Fremstad Ring™ is used as a sponge. The device material consists of cellulosic and synthetic fibers. 14mm diameter, round, inner diameter 11mm, thickness 0.1 mm.

This 510(k) summary describes a new medical device, The Fremstad Ring™, an ophthalmic sponge, and its substantial equivalence to predicate devices. It focuses on sterility and biocompatibility testing. The document does not describe an AI medical device or a study involving human readers or AI algorithms. Therefore, I am unable to provide the requested information about acceptance criteria and an AI study, as those elements are not present in the provided text.

Specifically, the document contains:

• A general description of The Fremstad Ring™ and its intended use.
• A comparison table for substantial equivalence based on material and sterility with predicate devices.
• Details on sterility validation (ETO sterilization, SAL of 10^-6).
• Biocompatibility studies (cytotoxicity, ocular irritation, sensitization) and their conclusions.
• A letter from the FDA confirming substantial equivalence for the device.

Since the provided text does not relate to an AI device or a study assessing its performance against acceptance criteria, I cannot fulfill the request for information regarding AI performance metrics, sample sizes for test/training sets, expert qualifications, or MRMC studies.

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The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ silicone lenses for surgical placement in the human eye.

STAAR Surgical Company's Foam Tip™ Injector is used to fold and insert STAAR Surgical UV-ELASTIC™ silicone intraocular lenses for surgical placement into the human eye. The new Foam Tip™ Injector utilizes the same design principles (i.e. a plunger pushing or threaded mechanism) to push the IOL through a cartridge for injection into the eye as the existing MicroSTAART™ injectors. The new injector system differs from the MicroSTAART™ injector in that it contains a disposable Foam Tip™ plunger insert which may be attached to the sterilized injector body prior to lens loading. This attachable Foam Tip™ plunger insert is encapsulated inside a holder that protects the sponge from damage. The holder acts to guide the plunger as it slides into the injector body and performs as a wrench to remove the plunger from the injector once the lens has been implanted. Once the sponge portion of the foam plunger insert is hydrated, it enables the surgeon to have greater control in ejecting the lens properly through the cartridge and into the eye. Like the existing MicroSTAAR™ injectors, the new Foam Tip™ Injector body is provided sterile and can be resterilized for multiple use. The new Foam Tip™ plunger insert is also provided sterile but is intended for single use only.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the Foam Tip™ Injector System (K980696):

Acceptance Criteria and Device Performance for Foam Tip™ Injector System (K980696)

1. Table of Acceptance Criteria and Reported Device Performance

Additional Acceptance Criteria and Performance (Accelerated Aging Studies)

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

• Sample Size: 40 functional ejection tests were conducted for the functional testing.
• Data Provenance: The text does not explicitly state the country of origin or whether the study was retrospective or prospective. It describes laboratory or in-house testing performed by or for STAAR Surgical Company.

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

The document does not specify the use of "experts" to establish ground truth in the traditional sense of clinical opinion or image interpretation. The ground truth for functional performance (lens tears, haptic damage, resolution efficiency, particulates) was established through direct observation and measurement in a controlled testing environment, likely by trained technicians or engineers.

4. Adjudication Method for the Test Set

Not applicable. The criteria for functional testing were objective and directly observable/measurable (e.g., presence/absence of tears, adherence to resolution requirements). There was no "adjudication" between multiple expert opinions.

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

No. This document describes non-clinical functional and accelerated aging tests of the device itself, not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This device is a mechanical injector system, not an algorithm or AI. The tests performed are standalone in the sense that they evaluate the physical device's performance directly.

7. The Type of Ground Truth Used

The ground truth was established through objective physical measurements and observations within a controlled laboratory setting (e.g., visual inspection for tears/damage, resolution testing, particulate analysis, microbial challenge results, chemical analysis).

8. The Sample Size for the Training Set

Not applicable. This is a non-AI/algorithm device. The concept of a "training set" does not apply to the development and testing of a mechanical injector system in this context.

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

Not applicable, as no training set was used.

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The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.

The Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are packaged individually as a sterile, dried and compressed sponge. They are used to absorb fluids from the operative field in ophthalmic surgery. M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde.

This is a 510(k) premarket notification for a medical device, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified. This pathway focuses on equivalence rather than clinical performance studies demonstrating meeting specific acceptance criteria as you might find in a clinical trial for a novel device.

Here's what can be extracted based on the provided text, and where information is missing:

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

• Acceptance Criteria: Not explicitly defined or reported in the document. The basis for clearance is "substantial equivalence" to predicate devices.
• Reported Device Performance: Not reported in terms of specific metrics (e.g., accuracy, sensitivity, specificity). The claim is that the devices are "identical in size, shape, material composition and intended use" to the predicate devices.

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable/not provided. This document is a premarket notification for substantial equivalence, not a clinical study report with a test set.
• Data provenance: Not applicable.

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

• Not applicable. Ground truth establishment for a test set is not part of a 510(k) substantial equivalence submission for this type of device.

4. Adjudication method for the test set

• 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

• Not applicable. This is not an AI-based device, and no MRMC study is mentioned.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• Not applicable. For a 510(k) based on substantial equivalence for this type of device, the "ground truth" is essentially the established safety and effectiveness profile of the predicate device(s).

8. The sample size for the training set

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

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

• Not applicable.

Summary of Device and 510(k) Basis from the Text:

• Device Name: Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch.
• Intended Use: To absorb fluids from the operative field in ophthalmic surgery.
• Material: Formalized PVA sponge.
• Regulatory Basis: Substantial equivalence (510(k)) to predicate devices (Merocel Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears).
• Reason for Substantial Equivalence Claim: The M-PACT devices are "identical in size, shape, material composition and intended use" to the Merocel predicate devices. The only differences mentioned are in labeling and packaging.

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