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Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.

Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed.

The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.

This document is a 510(k) clearance letter for the Qitexio® 4-Way Stopcock, a physical medical device (an intravascular administration set), not an AI/Software as a Medical Device (SaMD).

Therefore, many of the requested criteria related to AI/SaMD performance studies (e.g., sample size for test/training sets, ground truth establishment for AI, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Bench testing: Verifying physical properties, mechanical integrity, and resistance to fluids.
• Biocompatibility testing: Ensuring the materials are safe for patient contact.
• Sterilization and packaging integrity testing: Confirming the device remains sterile and its packaging intact.
• User-related risk analysis: Assessing potential human factors issues.

Below is an attempt to address your request based only on the information provided, highlighting why certain sections are not applicable to this physical device.

Acceptance Criteria and Device Performance for Qitexio® 4-Way Stopcock

As the Qitexio® 4-Way Stopcock is a physical medical device, not a software or AI-based device, the concept of "acceptance criteria" and "device performance" in this context refers to meeting established engineering, material, and safety standards rather than diagnostic accuracy or algorithmic performance metrics. The information provided in the 510(k) summary focuses on demonstrating that the device meets these standards and is substantially equivalent to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not present a single, consolidated table of quantitative acceptance criteria with specific performance values. Instead, it refers to compliance with recognized consensus standards (e.g., ISO, ASTM, USP) and internal criteria. The "Conclusions" column in Table 2 (Performance Testing) serves as the "reported device performance" by stating that the test results were "satisfactory for the requirements" or "compliant with Medex internal criteria."

Here's an attempt to synthesize the closest equivalent based on the provided text, focusing on the key performance attributes mentioned:

Information Not Applicable to This Device Type (Physical Medical Device)

The following points are not applicable to this 510(k) submission as it pertains to a physical, non-AI/software medical device. If this were an AI/SaMD, this information would be critical.

• 2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for a physical device refers to bench testing on physical samples, not a data test set for an algorithm. There is no "data provenance" in the sense of clinical data from patients.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and laboratory standards and measurements, not expert consensus on clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in expert labeling of data, which is irrelevant for physical device 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. MRMC studies are used for evaluating the impact of AI on human reader performance, which doesn't apply to a mechanical stopcock.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance, not a physical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for this device is based on established engineering and material science standards (e.g., "Luer Lock standard," "ISO," "ASTM," "USP" requirements).
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical medical device.
• 9. How the ground truth for the training set was established: Not applicable. No training set for a physical medical device.

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Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, gentourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: orthopedics.

The Aurolance AM diode laser system consists of a unit, footswitch, power cord assembly, unit key, and protective eyewear. The Aurolance 980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The Aurolance 810 diode laser system consists of a unit, footswtich, power cord assembly, unit key and protective eyewear. The LaserPro D980 diode laser system consists of a main unit, footswtich, power cord assembly, unit key, and protective eyewear. The LaserPro D810 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear.

A review of the provided PDF reveals that it describes the FDA's decision to clear several Diode Laser Systems for marketing based on their substantial equivalence to previously marketed predicate devices. It does not contain information about acceptance criteria, the specific studies performed, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance. The document focuses on regulatory approval rather than detailed performance evaluations of an AI/ML algorithm.

Therefore, I cannot provide the requested information because the provided text does not contain the details about acceptance criteria and studies for an AI/ML device. The document is an FDA 510(k) clearance letter for a physical medical device (Diode Laser System), not an AI/ML software device.

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The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.

·Laser must operate at a wavelength between 532 and 1064 nm.

• Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.

• · Laser must have a numerical aperture of 0.35 or less.
  · Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector.

Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected.

During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.

The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.

The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a non-AI medical device (SLT Select Fiber Delivery System and Contact Tips).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details for an AI device from the provided text.

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TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

The TopFine® LDS (Low Dead Space) Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is a permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and is manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by Ethylene Oxide gas.

The proposed device has 2 models depending on the diameter of the needle.

The provided document is a 510(k) premarket notification for a medical device, specifically a syringe. It does not contain information about an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, it is not possible to describe acceptance criteria or a study related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence of the "TopFine® LDS (Low Dead Space) Syringe" to a predicate syringe through various performance tests and material comparisons.

Here's an analysis based on the information provided, specifically addressing the technical performance of the syringe, not AI/ML:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Syringe)

The document details various performance criteria for the syringe. There isn't a single table explicitly labeled "Acceptance Criteria and Reported Device Performance" with detailed numerical results for each criterion. However, the "Comparison of technological characteristics with the predicate device" section (page 5) and "Performance data" section (page 7) implicitly define the acceptance criteria by stating compliance with recognized standards and providing general results.

Here's an attempt to construct a table based on the provided information, focusing on criteria where reported performance is available, even if only generally stated as "Same" or "Complies."

Since this is concerning a non-AI/ML medical device, the following points are not applicable or cannot be answered from the provided text:

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 specify exact sample sizes for each physical or biological test. It only mentions that tests were "conducted."
   • Data provenance (country of origin, retrospective/prospective) is not mentioned for the testing data.

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 this is not an AI/ML device requiring expert ground truth for image/data interpretation. This refers to standard performance testing.

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

   • Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or AI/ML output.

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. "Clinical studies were not required to support substantial equivalence."

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.

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

   • For the syringe, "ground truth" would be established by direct physical measurements, chemical analyses, and biological assays according to the specified international and national standards (e.g., ISO, USP, ASTM). For example, the "dead space" measurement itself would be the ground truth for that specific characteristic, and the acceptance criterion is a predefined maximum value (≤ 0.03 ml).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device with a training set.

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

   • Not applicable. This is not an AI/ML device.

In summary, the document addresses a traditional medical device (syringe) and demonstrates its substantial equivalence to a predicate device through adherence to manufacturing standards, material comparisons, and performance testing against established physical, chemical, and biological criteria, rather than through AI/ML performance metrics.

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Qitexio Luer Lock Syringes are manual devices used to inject fluids into the body. They are also used for delivery of Lipiodol (Ethiodized Oil) Injection.

Medex, a subsidiary of Guerbet Group, designed and manufactures the Qitexio® Luer Lock Syringe, a disposable, handheld syringe available in 3 different volumes (1, 3 and 20 mL). Oitexio® Syringes are standard syringes which are verified to endure the potentially damaging chemical effects of Lipiodol® (Ethiodized Oil), an oil-based contrast media manufactured by Guerbet.

Qitexio® Luer Lock Syringes are manual devices used to inject fluids into the body. Qitexio® Syringes are also used for delivery of Lipiodol® (Ethiodized Oil) Injection.

They are single-use devices, sterilized by gamma radiation.

Standard five-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting movable plunger, O-Ring, rotative finger flange, and backstop. Fitting offered with male luer lock.

This document describes the premarket notification (510(k)) for the Qitexio Luer Lock Syringes, a medical device. The information provided heavily focuses on proving the substantial equivalence of the new device to a predicate device, the Merit Syringe (K173601).

The acceptance criteria for this type of device (a piston syringe) are primarily defined by conformity to established FDA recognized consensus standards and a battery of performance, biocompatibility, and sterilization tests. The document does not describe an AI/ML-driven device or study. Therefore, some of the requested information regarding AI/ML study design, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable to this submission.

Here's a breakdown of the acceptance criteria and proof, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Qitexio Luer Lock Syringes, acceptance criteria are generally met by demonstrating conformity to recognized consensus standards and by passing specific performance tests. The document repeatedly states that the device "complies with" or "met the established acceptance criteria" for these standards and tests. Specific numerical performance results are not provided in this summary, as is common for 510(k) summaries which focus on demonstrating equivalence rather than presenting raw data.

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Autokeeper® Safety Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Not Found

This FDA letter is a 510(k) clearance for the Autokeeper® Safety Pen Needle. It primarily addresses regulatory compliance and substantial equivalence to a predicate device. It does not contain a detailed study report or acceptance criteria for device performance as would be found in a clinical study or detailed engineering report.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from the provided text. This document is a regulatory approval letter, not a scientific study report.

To provide the requested information, a different document, such as a summary of safety and effectiveness data or a clinical study report, would be necessary.

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Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.

Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

The document provided describes the Top Fine® Pen Needle and its equivalence to a predicate device (Feel Fine Insulin Pen Needle). The acceptance criteria are based on bench testing to demonstrate equivalent performance to the predicate device.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Notes:

• The document explicitly states that the "principal device demonstrated equivalent performance to the predicate devices during bench testing" and that "The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864." The general conclusion statement also implies compliance for other aspects.
• For several criteria, specific numerical acceptance limits are not provided in the document, but compliance with the standards (ISO 11608-2, ISO 7864, ISO 11135, USP 39, KP 11) serves as the acceptance criteria.

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

• Sample size for the test set: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench tests" being conducted.
• Data provenance: The tests were conducted by MedExel Co., Ltd. in Korea (company address listed as "252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea"). The nature of bench testing implies the data would be prospective for the device being tested.

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

Not applicable. The "ground truth" for a medical device like a pen needle typically refers to its physical and functional performance against established engineering and medical standards, not expert opinions or diagnoses. The "bench tests" are designed to objectively measure these parameters.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation relies on objective measurements against engineering and medical standards, not subjective expert judgment requiring adjudication.

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 hypodermic single lumen needle, not an AI-powered diagnostic tool. Therefore, MRMC effectiveness studies with human readers 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

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is evaluated through physical and functional bench tests.

7. The type of ground truth used

The ground truth used is based on established engineering and medical device standards and objective physical and functional performance measurements. Specifically, the document mentions:

• ISO 11608-2:2012 (Needle systems for medical use - Part 2: Needles for pen injectors)
• ISO 7864:1993 (Sterile hypodermic needles for single use)
• ISO 11135: 2007 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices)
• USP 39: Bacterial Endotoxin test
• KP 11: Endotoxin Test Method

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.

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

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

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UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

The XTRAC Ultra Excimer Laser System, Model AL10000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength of 308 nm. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.

This document describes the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000. However, the provided text does not contain information about acceptance criteria or a study proving the device meets them in the way a typical diagnostic or AI device submission would.

Instead, this is a 510(k) premarket notification for a medical device that appears to be seeking substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials to demonstrate efficacy from scratch.

Here's an analysis based on the provided text, highlighting what is and is not present:

Acceptance Criteria and Study for PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000

The provided 510(k) summary for the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, does not detail explicit acceptance criteria for clinical performance or a rigorous clinical study designed to prove the device meets such criteria. Instead, the submission relies heavily on substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a substantial equivalence submission for a laser device, the "acceptance criteria" revolve around demonstrating that the new device's technological characteristics (e.g., wavelength, energy output, repetition rate, safety features) are either identical to or do not raise new safety or efficacy concerns compared to the predicates. The clinical performance itself is accepted based on the established performance of the predicate devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size (Test Set): Not applicable. No new clinical "test set" was used for performance evaluation in the context of this 510(k) submission.
• Data Provenance: Not applicable. The submission refers to previously cleared indications and performance of predicate devices, rather than new data generated for this specific model's effectiveness.

3. Number of Experts and Their Qualifications (for Ground Truth)

• Not applicable. No new ground truth establishment by experts for a test set is described in this submission. The efficacy of UVB phototherapy for the stated conditions is presumably well-established from the predicate devices' clearances.

4. Adjudication Method (for Test Set)

• Not applicable. No new clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is a laser system for dermatological treatment, not a diagnostic imaging or AI-assisted interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This device is a physical laser system, not an algorithm.

7. Type of Ground Truth Used

• Implicit Ground Truth: The ground truth for the efficacy of targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma is implicitly derived from the clinical evidence and regulatory clearances of the predicate devices. The submission argues that since the new device operates similarly and introduces no new safety/efficacy issues, the prior established "ground truth" (i.e., that these treatments are effective for these conditions) applies.

8. Sample Size for the Training Set

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

9. How Ground Truth for the Training Set Was Established

• Not applicable.

Summary of Approach:

The PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, gained market clearance through the 510(k) substantial equivalence pathway. The core argument is stated in Section 6 and 7:

• Identical Intended Use: The intended use (targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma) is identical to previously cleared predicate devices (K992914, K003705, K011382, K020847, K031451, K041943).
• Similar Technology: The difference is "limited to a moderate increase in the maximum laser repetition rate."
• No New Safety/Efficacy Issues: The manufacturer believes this increase "will not affect the device's safety or intended use as compared to the identified predicates."
• No Duplicative Clinical Data Required: Because the device "does not introduce any new indications for use, and will perform in an identical manner as the identified predicates," PhotoMedex states that "duplicative clinical data is not required."

Instead of clinical performance testing, the submission highlights Product Performance Testing (Section 8), which includes:

• Conformance to IEC 60601 standards.
• Conformance to 21 CFR Part 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products).
• Certification to UL 60601-1 Medical Electrical Equipment classification standard.
• Risk management utilizing ISO 14971.

These product performance tests ensure the device meets safety and operational standards but do not constitute clinical efficacy trials as would be expected for a novel diagnostic or therapeutic approach.

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UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.

The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which is effective for the treatment of skin conditions that respond favorably to and available UV-B phototherapy. UV-B is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that require treatment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.

The provided text describes a 510(k) summary for the VTRAC Excimer Lamp System. Unfortunately, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a novel study with specific performance metrics against acceptance criteria. It mentions that the device is "designed, tested and are to be manufactured in accordance with both mandatory and voluntary standards" (e.g., 21 CFR PART 820, EN60601-1, etc.) to ensure safety and effectiveness. However, it does not provide the results of such testing or a direct comparison to acceptance criteria.

Therefore, I cannot provide the detailed table and information as requested because the source document does not contain this specific type of clinical or performance study data.

Here's what I can extract based on the provided text, acknowledging the limitations:

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" Argument):

Missing Information (Not available in the provided text):

1. Sample size used for the test set and the data provenance: Not applicable as a specific test set for performance against acceptance criteria in a study is not described. The "published clinical data" mentioned is not detailed or provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method: Not applicable.
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 an excimer lamp system for phototherapy, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
6. The type of ground truth used: Not applicable for a performance study. Clinical outcomes and expert assessment would typically be the ground truth for treatment efficacy had a study been detailed.
7. The sample size for the training set: Not applicable as this is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a medical device (an excimer lamp system). It focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a detailed clinical study with specific performance acceptance criteria and results from a test set. The "acceptance criteria" are implied by the safety and effectiveness of the predicate devices and compliance with general standards.

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This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.

The provided text describes a 510(k) submission for the "p&p Safety Syringe," seeking clearance based on substantial equivalence to a predicate device, the "SEZ safety syringe [K031163]". The document focuses on comparing the new device to the predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy, etc.) as might be found for a diagnostic algorithm.

Instead, the "clinical investigation" mentioned is likely a human factors study or a performance study designed to demonstrate that the safety mechanism of the p&p Safety Syringe functions as intended and is comparable to or better than the predicate device in terms of preventing needlestick injuries, as per guidance documents like "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA."

Given the information provided, here's a breakdown, with acknowledgements of missing details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets (e.g., "must achieve X% reduction in needlestick injuries"). Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the SEZ safety syringe [K031163], in terms of:

• Intended Use: Identical clinical application (intramuscular and subcutaneous injections, prevention of needlestick injuries).
• Principle of Operation: While the mechanism of activation differs, the outcome (locking the needle to prevent injury) is equivalent. The provided text details the steps for each device's safety feature activation.
• Performance Characteristics:
  • Volume: 3ml/cc (Identical)
  • Nozzle type: Male conical lock fitting (Luer Lock Tip) with rotatable internally threaded neck, functionally equivalent to the predicate's female conical lock fitting with rotatable internally threaded neck for needle attachment.
  • Barrel Marking: Conforms to ISO7886-1:1993(E) (Identical)
  • Reuse: Non-reusable (Identical)
  • Biocompatibility: Conforms to ISO 10993-1 (Identical)
  • Materials: Identical (Polypropylene, thermoplastic rubber, Medipeel film, Ethypel paper)
  • Sterility: Sterilized by ethylene oxide gas, SAL = 10-6 (Identical)

The "reported device performance" is that "The results of the investigation showed that the p&p Safety Syringe is clinically acceptable" and "In all material respects, the p&p Safety Syringe is substantially equivalent to the predicate device." While not precise metrics, this is the reported performance against the overarching regulatory requirement of substantial equivalence.

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

The document mentions "A clinical investigation was performed," but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full study report, which is not provided here.

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

This information is not provided in the document. For a medical device focused on safety features, "experts" might refer to healthcare professionals evaluating the ease of use and effectiveness of the safety mechanism.

4. Adjudication Method for the Test Set

This information is not provided.

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

No, an MRMC comparative effectiveness study in the context of diagnostic AI (e.g., radiologists interpreting images with and without AI assistance) was not done. This submission is for a physical medical device (safety syringe), not a diagnostic algorithm. The "clinical investigation" mentioned would likely involve observational studies or human factors assessments of the syringe's physical safety mechanism.

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 safety syringe, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for a safety syringe would primarily be established through:

• Experimental testing: Verifying the mechanical function of the safety lock (e.g., does it consistently lock, can it be easily unlocked unintentionally).
• Human factors evaluation/clinical observation: Assessing whether healthcare professionals can effectively activate the safety mechanism in a clinical setting and if it demonstrably reduces the risk of needlestick injuries.
• Comparison to predicate device performance: Demonstrating that the new device performs at least as well as a legally marketed device in preventing injuries.

The document states, "A clinical investigation was performed, and test for the comparison between p&p Safety Syringe and the legally marketed predicate device was performed in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'." This guidance would outline the expected methods to establish "ground truth" or evidence of effectiveness for such devices, which primarily relies on performance testing and potentially user studies to confirm the safety feature's efficacy.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical safety syringe and does not involve AI model training.

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

This question is not applicable as the device is a physical safety syringe and does not involve AI model training.

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