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Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.

The 23ga and 25ga Adjustable Chandelier Illuminators are made to work with the Bausch and Lomb surgical system and Bausch and Lomb Valved ESA (Entry Site Alignment) systems (K012435). These devices are to be manufactured with distally located "Infusion Cannulas" that adequately secure themselves within 23ga and 25ga Bausch and Lomb Valved ESA Systems. The 23ga and 25ga Adjustable Chandelier Illuminators consist of a PMMA (Polymethylm-ethacrylate with Flourinated Polymer Cladding) acrylic fiber (for light transmission), white acetal handle assembly with finger slide for adjustability, PTFE (Polytetrafluor-oethylene) jacket (for fiber) and Stellaris style light connector to fit into the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486). The 23ga and 25ga Adjustable Chandelier Illuminators are to be provided sterile to the user, is a single-use device and is packaged in double Tyvek-to-poly pouches to facilitate introduction to the sterile environment. These provide illumination for eye surgery.

This document describes the premarket notification (510(k)) for the Peregrine 23ga and 25ga Adjustable Chandelier Illuminator. The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical performance tests conducted to evaluate the device. The reported performance is that all results were "acceptable" and the device "satisfactorily met the requirements." Specific numerical acceptance criteria or performance metrics are not provided in this summary.

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

The document does not explicitly state the numerical sample size for individual tests. However, it indicates that "Biocompatibility and sterility testing has been conducted on the 25ga Adjustable Chandelier Illuminators as a 'worst case device' and a family representative." This suggests a limited sample size, focusing on one representative (25ga).

The data provenance is internal, originating from Peregrine Surgical Ltd. It is retrospective, as these are bench tests conducted to support a premarket submission. No information about the country of origin of the data is provided beyond the company's location (New Britain, PA, USA).

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

Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The tests performed are bench tests evaluating physical and functional characteristics of a medical illuminator. The "ground truth" for these tests would be the established standards and specifications outlined in the referenced ISO and ASTM methods, or the company's internal test protocol specifications.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic assessment requiring adjudication among experts. The tests are objective measurements against defined 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

Not applicable. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device. The "standalone" performance refers to the device's functional characteristics as an illuminator, which were assessed through the listed bench tests.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance data is the defined acceptance criteria and specifications within the referenced ISO, ASTM, and Internal Test Methods. For example:

• Sterility: The device must meet the sterility assurance level (SAL) specified in ISO 11135-1.
• Biocompatibility: The device materials must meet the biological safety requirements outlined in ISO 10993-01.
• Light Output: The device's light output must meet the specified lumen value (3.7 lumen, as indicated in Table 5.2).

8. The Sample Size for the Training Set

Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.

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

Not applicable. No training set was used.

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Peregrine's 25ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, a Delrin handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an actylic fiber with PVC jacket and an aluminum illumination connector. Both connectors plug into existing laser and light sources.

The Laser Probe can only be used in combination with a medical laser in the Vis-NIR transmission range of 532nm to 810mm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The light portion of the device is designed for use with the Alcon Constellation Vision System. The Constellation uses a 50 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 400nm to 700mm.

The outer dimension of the glass fiber to be used in the proposed device is 98 microns or about .004 inches, which is about 25% of the size of the glass fiber in Peregrine's predicate device.

The acrylic fiber that will be used has an outer dimension of 254 microns or .01 inches, which is 25% of the size of the acrylic fiber used in the predicate device. The decrease in size of both fibers has created an acceptable device.

Here's a breakdown of the acceptance criteria and study information for the Peregrine 25ga Curved Illuminating Laser Probe, based on the provided text:

Device: Peregrine 25ga Curved Illuminating Laser Probe (PD725.37SA)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly derived from the comparison to the predicate device and the successful completion of performance tests. The goal was to demonstrate substantial equivalence, meaning the new device performs at least as safely and effectively as the predicate.

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

The document does not explicitly state a "test set" in the context of human data or a specific number of devices tested for each performance characteristic. Instead, it refers to:

• "3 performance tests" to evaluate light output, laser power output, and laser field clarity. The sample size for these tests is not specified.
• "Bend testing" performed on both the existing and proposed designs. The number of samples for bend testing is not specified.
• Biocompatibility testing. The number of material samples tested is not specified.
• Sterilization and shelf-life validation. This would involve a specific number of packages/devices, but the exact count is not given.

The data provenance is Peregrine Surgical Ltd. internal testing. The document does not specify country of origin for test data, nor does it explicitly state if it was retrospective or prospective, though performance and material testing are typically prospective.

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

Not applicable. The document describes engineering and material performance testing rather than studies involving expert human review of medical images or diagnoses. The "ground truth" here is based on measurable physical properties and compliance with established material and manufacturing standards.

4. Adjudication method for the test set

Not applicable. This type of adjudication (e.g., 2+1, 3+1) is relevant for studies where human experts interpret data (like images) and resolve discrepancies. The provided document details technical performance and material testing.

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 device is a surgical tool (laser probe), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

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

Yes, in essence, standalone performance tests were done. The "3 performance tests" (light output, laser power output, laser field clarity), "bend testing," and biocompatibility testing represent the standalone performance evaluation of the device itself, without human interpretation in a diagnostic context. The device's function is to transmit laser and light energy, and these tests evaluate that function directly.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily based on:

• Physical measurements and engineering specifications: Metrics like laser power efficiency, spot size, fiber dimensions, length, weight, etc., are directly measured and compared against the predicate device's established performance parameters.
• Material standards: Biocompatibility is assessed against established biological safety standards. Nitinol's use is justified by its existing approval in other ophthalmic devices and by specific bend testing.
• Sterilization and shelf-life validation standards: Compliance with AAMI Overkill Method according to ISO 11135-1 and residual testing.

8. The sample size for the training set

Not applicable. This device's development and evaluation do not involve machine learning or AI, so there is no "training set."

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

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

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources.

The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).

Here's an analysis of the provided text regarding the acceptance criteria and study for the 23ga Curved Illuminating Laser Probe (K122997).

It's important to note that this 510(k) summary is for a substantially equivalent device, meaning much of the performance evaluation relies on demonstrating equivalence to an already cleared predicate device (Peregrine's Illuminated Laser Probe, K031023) rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information provided isn't as detailed as what might be found for a novel device.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate device. The goal is to show that the new device either meets or performs similarly to the predicate in key areas, or that any differences do not raise new questions of safety or effectiveness.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved comparing parameters of one new device (23ga Curved Illuminating Laser Probe) against one predicate device (PD600.10).
   • Data Provenance: The testing was conducted by the manufacturer, Peregrine Surgical. No information on the country of origin or whether it was retrospective/prospective is provided, but it would have been prospective testing specifically for this 510(k) submission.

2. 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)

   • Not applicable in the context of this device. This is a comparison of physical and functional characteristics of medical instruments, not an evaluation requiring expert consensus on images or diagnoses. The "ground truth" for performance is established by direct measurement and comparison to the predicate's known performance or accepted engineering standards.
   • The document mentions that "Surgeons understand that light outputs are compromised due to the use of smaller needle/tube gauges," implying a general expert consensus or understanding within the ophthalmic surgical community, but no specific experts were involved in a formal ground truth establishment process for the test set.

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

   • Not applicable. This is not a study requiring adjudication of findings. Performance measurements were objective.

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 is a physical ophthalmic instrument, not an AI-powered diagnostic device, so no MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm. Performance tests were done on the device itself.

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

   • The "ground truth" for demonstrating substantial equivalence was the measured performance of the legally marketed predicate device (PD600.10) and established engineering/biocompatibility standards. For biocompatibility, testing results demonstrating 100% biocompatibility according to recognized standards served as the ground truth. For sterility, the specified SAL and validation method (AAMI Overkill, ISO 11135-1) serve as the ground truth.

7. The sample size for the training set

   • Not applicable. This is a physical device, not an AI-based system requiring a training set.

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

   • Not applicable given that no training set was used.

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For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.

The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability. It consists of a connector that gets plugged into the Coherent/Alcon laser, a silicone aspirating line with female luer which attaches to an aspiration line associated with the operating system, a glass fiber with PVC jacket, a silicone reflux boot, a Delrin handpiece, a 304 stainless needle and silicone sleeve (soft tip) attached to the distal tip of the stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

The provided document is a 510(k) Premarket Notification for the Peregrine Soft Tip Aspirating Laser Probe. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these documents.

Here's the information that can be extracted or deduced from the provided text, along with an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria for novel safety and effectiveness endpoints. The document lists comparative characteristics to predicate devices, but these are not presented as acceptance criteria for specific performance metrics of the new device.

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

This information is not applicable/provided. The 510(k) submission does not describe a clinical study with a "test set" in the context of evaluating performance against acceptance criteria. The comparison is based on device characteristics and intended use.

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

This information is not applicable/provided. As no clinical study or test set for performance evaluation is described, there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No test set and associated adjudication method are described.

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 device is an ophthalmic laser delivery and aspiration probe, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study or AI-related effectiveness analysis is irrelevant.

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

This information is not applicable. The device is a medical instrument, not an algorithm.

7. The type of ground truth used

This information is not applicable/provided. No specific ground truth establishment for performance evaluation is discussed since it's a 510(k) submission for a device, not a diagnostic algorithm. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. As it's a physical medical device and not an AI/algorithm, there is no "training set."

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

This information is not applicable/provided. As there is no training set, there's no ground truth establishment for it.

Summary of Relevant Information from the Document:

While the document doesn't provide the requested study design details, it demonstrates the basis for its substantial equivalence claim, which is the regulatory standard for a 510(k) submission.

• Device Description: The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability, consisting of a connector, silicone aspirating line, glass fiber with PVC jacket, silicone reflux boot, Delrin handpiece, 304 stainless needle, and silicone sleeve (soft tip).
• Indications for Use: For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.
• Substantial Equivalence Basis: The device is compared to two predicate devices: "Aspirating Laser Probe" (K954308, Manufactured by Gamp & Assoc.) and "Infinitech Aspirating Laser Probe" (K946135, Manufactured by Infinitech). The comparison table highlights similarities in:
  • Light transmission for photocoagulation
  • 905 SMA laser connector
  • Delrin Handpiece
  • Optical Fiber (Glass - Silica Core, .008" / 200 microns)
  • Silicone aspirating line
  • Female connector
  • Silicone Reflux Boot
  • Silicone Soft Tip
  • PVC Jacket
  • 304 Stainless Needle (20 Gauge)
  • Max power output (1 watt)
  • One difference noted is the length: Peregrine's device is 101 inches, while predicates are 96 inches.
• Sterilization: The device will be ETO Sterilized, validated using the AAMI Overkill Method.

The FDA's letter on page 2 confirms that the agency "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the "proof" that the device meets the regulatory requirements for market entry under a 510(k), based on its similarity to already approved devices.

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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip

The Peregrine Illuminated Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

The provided text describes a 510(k) premarket notification for a medical device (Peregrine Illuminated Laser Probe). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

The document details:

• Device Description: What the device is composed of and its function.
• Intended Use: For photocoagulation and illumination during ophthalmic surgery.
• Substantial Equivalence Comparison: A comparison of the Peregrine Illuminated Laser Probe to two predicate devices, highlighting similarities and differences in components and specifications. This is a regulatory comparison to justify substantial equivalence, not a performance study.
• Sterility Information: States the device will be ETO sterilized and the validation method (AAMI Overkill Method).
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices and allows marketing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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For photocoagulation during ophthalmic surgery. To be used with (specified equipment).
For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The Peregrine Straight Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

The provided text is a 510(k) Premarket Notification summary for the Peregrine Straight Laser Probe. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on manufacturing and materials rather than performance data from a clinical study. Therefore, the document does not contain the information required to populate the acceptance criteria and study details as requested. This type of submission typically focuses on demonstrating equivalence to an already approved device through design, materials, and intended use, rather than presenting novel performance data from human or extensive animal studies.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details on sample sizes, data provenance, or the nature of any test sets.
3. Information about experts, ground truth establishment, or adjudication methods for performance evaluation.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
5. Standalone (algorithm-only) performance data.
6. Details on the type of ground truth used for performance evaluation, beyond inferring that the probe is intended to achieve photocoagulation.
7. Information on training set sample sizes or how their ground truth was established, as this is not an AI/ML device submission.

The closest relevant information is about sterility, where it states:

• Acceptance Criteria (Implied): The device will be ETO Sterilized to achieve sterility.
• Study (Method): The method used to validate the sterilization cycle is the AAMI Overkill Method. This is a standard validation method for sterilization, but no specific performance data (e.g., sterility assurance level achieved) is reported in this summary.

In summary, the provided text describes a medical device in the context of a 510(k) submission, which focuses on device description, indications for use, and substantial equivalence to predicate devices. It does not contain the detailed performance study data requested in your prompt.

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For the delivery of forced humidified air or fluid during ophthalmic surgery.

The Peregrine Wet Set is an 8' tubing set designed to deliver humidified air or fluid into the eye during ophthalmic surgery. It consists of the following: An 8' PVC tube running from an air supply unit to a three channel IV spike for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to inject the air from the air supply unit through the solution, while at the same time deliver humidified air and saline through a dual PVC tube. The dual PVC tube is designed to transport the humidified air in one side and the saline in the other. The dual PVC tube attaches at the other end to a three way stopcock.

The provided text is a 510(k) Premarket Notification Summary for the Peregrine Wet Set, an air/fluid tubing set for ophthalmic surgery. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as would typically be found for a device requiring such evidence for approval.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and reader performance cannot be extracted from this document.

However, based on the provided text, here is what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly list acceptance criteria as quantitative thresholds for performance. Instead, it relies on a "Substantial Equivalence Comparison" table to show that the Peregrine Wet Set has similar features to two predicate devices (GRIESHABER GLOBAL CONTROL and ALCON VGFI TUBING SET). The "reported device performance" is implicitly that the device functions comparably to these predicate devices based on its design features.

   FEATURES	GRIESHABER GLOBAL CONTROL (Predicate)	ALCON VGFI TUBING SET (Predicate)	PEREGRINE WET SET (Device)
   Number of channels in drip chamber spike	2	2	3
   Pressurized air enters bottle	/INTO FLUID	/INTO AIR SPACE	/INTO FLUID
   Pressurized air to stopcock delivered from	AIR SYSTEM	AIR SYSTEM	BOTTLE
   Fluid Source	BOTTLE	BOTTLE	BOTTLE
   Air system required	YES	YES	YES
   Bottle hung at eye level	YES	YES	YES
   Bottle pressurized by air system	YES	YES	YES
   Delivery line for fluid to stopcock	YES	YES	YES
   Delivery line for air to stopcock	YES	YES	YES
   3-way stopcock for air/fluid selection	YES	YES	YES
   Filter at air line attachment to system	YES	YES	YES
   Extension tube into bottle air space	NO	YES	YES

   The key "acceptance criteria" here appear to be demonstrating that the Peregrine Wet Set possesses the functional characteristics necessary for its intended use, a fact supported by its design being largely analogous to legally marketed predicate devices, with some minor differences noted (e.g., 3 channels vs. 2, and the source of pressurized air to the stopcock). For sterility, the acceptance criterion is that it is ETO sterilized, with validation using the AAMI Overkill Method.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document does not describe a clinical performance study with a test set. This device is a tubing set, and its approval appears to be based on substantial equivalence to existing devices and verification of sterility, rather than performance in a patient cohort.

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):
   Not applicable, as no clinical performance test set or ground truth establishment by experts is described for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical performance test set or adjudication process is described.

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 device is a simple tubing set used for delivering air or fluid, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical performance study requiring ground truth is described. The relevant "truths" for this submission are the device's physical features, materials, and sterilization efficacy, which are evaluated against established standards and predicate devices.

8. The sample size for the training set:
   Not applicable. There is no training set mentioned for this device, as it is not an AI/machine learning device.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

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For pneumatic infusion of silcone oil into the posterior segment.

The Peregrine V.F.I. Tubing Set is 8' in length and designed to infuse silicone oil into the posterior segment of the eye. It consists of the following: A connector at the proximal end to fit into a pneumatic injection system, 8' PVC tubing running from the connector and attaching to a Delrin Syringe Head which incorporates a .2um filter, and a syringe assembly (Terumo) which is attaches to the syringe head.

The provided document is a 510(k) Premarket Notification for a medical device called the "V.F.I. (Viscous Fluid Injection) Tubing Set." It seeks to establish substantial equivalence to a predicate device, rather than demonstrate performance against specific acceptance criteria through a study.

Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) are not applicable to this type of regulatory submission.

The document primarily focuses on:

• Device Description: What the Peregrine V.F.I. Tubing Set is and what it's used for.
• Substantial Equivalence Comparison: Directly comparing its features to a legally marketed predicate device (Grieshaber & Co. V.I.S. Pack Tubing Set).
• Sterility: Mentioning that the device will be ETO sterilized and the validation method (AAMI Overkill Method).
• Intended Use: For pneumatic infusion of silicone oil into the posterior segment.

Key points from the document regarding the "study" for regulatory approval:

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device. This is determined by comparing its design, materials, indications for use, and technological characteristics.
• Study Proving Equivalence: The "study" is a comparative textual analysis presented in Section {1} "Substantial Equivalence Comparison." It lists features of the Peregrine V.F.I. Tubing Set alongside the predicate Grieshaber & Co. V.I.S. Pack Tubing Set.
• Reported Device Performance: The document states: "The Peregrine V.F.I. Tubing Set, product #PD300.01, is identical to the Grieshaber V.I.S. Pack with the exception of the labeling specifications." This implies that its performance is expected to be identical to the predicate.

Here's a breakdown of the requested information based on the provided text:

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

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

• Sample Size: Not applicable. This was a comparative analysis of device specifications, not a clinical trial or performance study requiring a "test set" of patient data or device units to be run.
• Data Provenance: Not applicable in the context of a clinical or performance study. The data provenance is the design specifications of the Peregrine device and the known specifications of the predicate device.

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

• Not applicable. There was no "test set" requiring expert ground truth establishment in this type of submission. The "ground truth" for substantial equivalence is the set of specifications of the predicate device and the new device.

4. Adjudication method for the test set

• Not applicable. No "test set" or adjudication process for performance data was described.

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 device is a medical tubing set, not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a physical tubing set, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this 510(k) submission is the documented specifications and indications for use of the predicate device (Grieshaber V.I.S. Pack Tubing Set). The new device is then compared against this "truth" to establish equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of device submission.

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

• Not applicable. There is no "training set" for this type of device submission.

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For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.

The Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to minipulate tissue, irrigate and aspirate, and coagulate blood. It consists of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running through the handprece and outer stainless needle, protruding beyond the tip approximately 2.5mm. Electrical connection for RF current is made via fine insulated wires from the inner and outer needles to the solderless connectors which attach to the coagulator. A 30" length of silicone tubing with a luer connector at the proximal end of the handpiece. The luer connector may be attached to a syringe for irrigation asperation The 2.5mm extension may be used for tissue manipulation.

This document is a 510(k) Premarket Notification for the Peregrine Fiber Optic Multi-Function Manipulator, indicating it's a submission for clearance to market a medical device, not a study reporting on the device's performance against acceptance criteria.

The provided text does not contain acceptance criteria or detailed information about a study proving the device meets specific performance metrics. It's a regulatory submission document for market clearance based on substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. This information is typically found in design verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) summary.

The document primarily states:

• Device Description: Peregrine Fiber Optic Multi-Function Manipulator is a fiberoptic illuminator with capabilities to manipulate tissue, irrigate and aspirate, and coagulate blood.
• Indications for Use: For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
• Predicate Device: Grieshaber & Co. 3-Function Manipulator. The document presents a comparison of features between the two devices but no performance data.
• Sterilization: The device will be ETO sterilized using the AAMI Overkill Method for validation.
• Regulatory Status: The FDA found the device substantially equivalent to pre-amendment devices for its stated indications for use.

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