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The Rocket IPC Platinum Cured Catheter is intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice.

The Rocket IPC Platinum Cured Catheter is a fenestrated silicone drainage catheter indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the body. The Rocket platinum Cured Catheter is used alongside the Rocket IPC drainage line and Rocket IPC bottles (these we included in the Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).

The provided document is a 510(k) Premarket Notification for the Rocket Platinum Cured Catheter. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests, primarily bench testing. It does not describe a study involving an AI/machine learning device; therefore, many of the requested criteria related to AI/ML device performance (e.g., human-in-the-loop, expert consensus for ground truth, training set information) are not applicable.

Below is a summary based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them for this specific type of medical device (a physical catheter).

The Rocket Platinum Cured Catheter underwent a series of non-clinical performance tests to demonstrate its safety and effectiveness and its substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes "Table 9.1: Summary of Verification Testing" which details specific acceptance criteria and the results.

Additional performance data in "Table 9.2: Summary of Further Testing Performed" (Biocompatibility tests):

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

• Sample Size for Bench Testing: For the tests listed in Table 9.1, the sample size used was 3 units for each specific test (e.g., Resistance to deformation, Force at break, Freedom from leakage).
• Data Provenance: The tests are non-clinical bench tests performed on the device itself.
  • Country of Origin: The submitter is Rocket Medical Plc., located in Washington, Tyne & Wear, United Kingdom. The tests would likely have been conducted in the UK or by a contracted lab.
  • Retrospective or Prospective: These are prospective laboratory performance tests designed to evaluate the physical and biological characteristics of the device.

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

This question is largely not applicable as the studies are focused on physical and biological performance of the catheter, not diagnostic image analysis or clinical decision support where expert medical interpretation forms ground truth. The "ground truth" for these tests is established by objective physical measurements (e.g., force, leakage, flow rate, chemical composition) and standardized biological assay results against predefined specifications in recognized international standards (e.g., ISO, EN, ASTM). The "experts" involved would be qualified laboratory technicians and scientists following validated test protocols.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML device relying on human consensus for ground truth. These are objective engineering and biocompatibility tests. Results are determined by direct measurement against quantitative or qualitative pass/fail criteria from international standards.

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

No, a MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI/ML devices where human readers (e.g., radiologists) interpret cases with or without AI assistance. The Rocket Platinum Cured Catheter is a physical medical device (catheter) for drainage, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• International Standards: Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, EN 1617/1618 for catheters).
• Objective Bench Test Measurements: Quantifiable physical properties (e.g., force, pressure, flow rate, deformation) measured in controlled laboratory settings.
• Biocompatibility Assay Results: Biological responses (e.g., cytotoxicity, sensitization, pyrogenicity, toxicity, irritation) observed in standardized in vitro and in vivo models.
• Predetermined Specifications: The device's performance is measured against internal design specifications and requirements derived from the relevant standards, ensuring Pass or Fail.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable. As a physical device, there is no AI/ML training set or associated ground truth to establish.

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The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease.

The device is indicated for:

• The palliation of dyspnea due to pleural effusion
• Providing pleurodesis (resolution of the pleural effusion)

This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, it contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and no drugs. It is for use by surgeons where the patients are already draped and insertion components are readily available. The Rocket IPC Insertion Kits are provided sterile and are for single use only.
The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone catheter, with a barium sulfate stripe through its length, intended for the drainage of pleural effusion. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the pleural space. This valve can only be operated with the specifically designed drainage line and drainage bottles supplied by Rocket Medical.

The provided text is a 510(k) Summary for a medical device (Rocket Indwelling Pleural Catheter (IPC) Insertion Kit). It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a new clinical study to prove the device meets specific acceptance criteria in the manner one would for a novel AI/software medical device.

Therefore, many of the typical bullet points for AI/software device evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, ground truth establishment for AI models) are not applicable to this document, as it outlines a comparison to a predicate device based on existing performance data and technical specifications.

However, I can extract the closest information analogous to "acceptance criteria" and "device performance" in the context of this 510(k) submission, which revolves around demonstrating that the new device is as safe and effective as the predicate.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):

The "acceptance criteria" here are implicitly that the subject device's performance characteristics match or are demonstrably equivalent to those of the predicate device. The "reported device performance" is not from new testing of the subject device (for most aspects), but rather a statement that its performance is identical to the predicate due to identical components and principles.

Regarding the study that proves the device meets acceptance criteria (interpreted as proof of substantial equivalence):

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

   • This is not a "test set" in the machine learning sense. The "study" for substantial equivalence relies on existing data and specifications of the predicate device (K123033) and a reference predicate (K162457).
   • No new clinical data or specific sample sizes are mentioned for demonstrating the subject device's performance (outside of the pre-existing data for the predicate).
   • Provenance: The predicate device (K123033) and reference predicate (K162457) are also from Rocket Medical PLC, GB. The general context of 510(k) submissions relies on historical data and verified performance of existing devices. The terms "retrospective" or "prospective" are not applicable here, as it's a comparison to established devices.

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

   • Not applicable. This is not a study requiring expert ground truth for a test set. The "truth" is established by the prior FDA clearances of the predicate devices.

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

   • 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 is a physical medical device, not an AI/software device involving human readers.

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

   • Not applicable. This is a physical medical device.

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

   • The "ground truth" for proving substantial equivalence relies on pre-existing regulatory clearances, performance data, and technical specifications of the predicate device(s). For the added components (Lidocaine HCl, USP and DuraPrep), their "ground truth" for safety and efficacy comes from their individual clearances and conformance to USP monographs and manufacturer validations (e.g., for EtO sterilization).

7. The sample size for the training set:

   • Not applicable. This refers to AI/ML model training, which is not relevant here.

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

   • Not applicable. This refers to AI/ML model training, which is not relevant here.

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The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic. recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).

This document is a 510(k) premarket notification for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a Class II medical device used for intermittent drainage and palliation of symptoms related to recurrent malignant ascites. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; K152105).

The table provided details the "Substantial Equivalence" comparison between the subject device and its predicate. This section outlines various parameters where the subject device is deemed equivalent to the predicate, with a specific focus on performance, biocompatibility, packaging, sterility, sterilization method, and shelf life.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of strict numerical thresholds or target metrics for the device's clinical performance (e.g., success rates in draining ascites, complication rates). Instead, the "Performance" section within the "Substantial Equivalence" table describes the types of tests conducted to demonstrate equivalence to the predicate. Therefore, the "acceptance criteria" are implied to be meeting the established safety and performance characteristics of the predicate device as evaluated through the specified tests. The "reported device performance" is that the subject device performs similarly to the predicate under these tests.

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

The document describes performance testing (resistance to deformation, force at break, freedom from leakage) and biocompatibility testing. However, it does not specify the sample sizes used for these tests. The data provenance is implied to be from Rocket Medical Plc. (UK manufacturer). Given the context of a 510(k) submission primarily comparing the subject device to a predicate, these tests would typically be prospective experimental studies performed on samples of the subject device. The document does not mention any clinical studies using human patients for the direct evaluation of this specific device's general performance.

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

This document describes a 510(k) substantial equivalence submission, which relies heavily on laboratory-based performance testing and adherence to recognized standards (e.g., for biocompatibility). It does not mention the use of experts to establish "ground truth" in the context of clinical interpretation or diagnostic accuracy, as might be seen for an AI or imaging device. The "ground truth" for the performance tests would be defined by the measurement instruments and protocols used in the laboratory settings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" here refers to physical performance and biocompatibility tests, not clinical data requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic data (e.g., imaging devices with AI assistance) to assess the impact of the device on reader performance. The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device for draining fluids, not a diagnostic tool requiring human interpretation for its primary function.

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

No, a standalone performance evaluation (in the context of an algorithm or AI) was not done. This device is a physical medical device, not an algorithm or AI software.

7. The Type of Ground Truth Used

For mechanical performance and material properties, the "ground truth" is established by objective measurements against defined engineering specifications and international standards (e.g., ISO standards for breaking force, leakage).
For biocompatibility, the "ground truth" is established by validated laboratory assays (e.g., cytotoxicity tests, sensitization tests) according to recognized standards like ISO 10993.
For sterility, the "ground truth" is established by specific sterility testing methods to confirm a Sterility Assurance Level (SAL) of 10⁻⁶.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this device.

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The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit will consist of the IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.

The provided text describes the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a 510(k) premarket notification for a Class II medical device used for intermittent drainage of symptomatic, recurrent malignant ascites and palliation of related symptoms.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Beyond these specific tests, the document also mentions compliance with numerous ISO and EN standards related to biocompatibility, sterilization, packaging, and quality management systems (Sections 9.1 and 9.2). The overall conclusion is that "the Rocket IPC design met all specifications and is adequate for its intended use" (Section 10.1).

2. Sample Size used for the test set and the data provenance:

• Sample Size: For the specific performance tests listed in the table, the sample size used was 3 for each test.
• Data Provenance: The document does not explicitly state the country of origin for the test data, but the applicant's address is United Kingdom (Washington, Tyne and Wear, NE38 9BZ, United Kingdom). It does not specify if the testing was retrospective or prospective, but bench testing on new devices is typically considered prospective for that specific testing, even if the overall design builds on existing knowledge.

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

• This information is not provided in the document. The tests performed are engineering/performance bench tests against established standards, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication method for the test set:

• This information is not applicable as the tests are objective material/performance characteristic evaluations, not assessments requiring human adjudication of subjective data.

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:

• No, an MRMC comparative effectiveness study was not done. This document describes the regulatory submission for a physical medical device (catheter kit) and its performance characteristics, 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 catheter kit for drainage, not an algorithm.

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

• The "ground truth" for the performance tests was defined by the acceptance criteria of the referenced ISO and EN standards. These standards stipulate objective physical and functional requirements (e.g., minimum force at break, no leakage, no significant deformation). In essence, the standard is the ground truth for these engineering tests.

8. The sample size for the training set:

• This information is not applicable as this is a physical medical device, not a machine learning model that requires a "training set."

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

• This information is not applicable as this is a physical medical device.

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The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

The devices are indicated for:

1. The palliation of dyspnea due to pleural effusion
2. Providing pleurodesis (resolution of the pleural effusion).

The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.

The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of pleural effusions. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the pleural cavity. The IPC System will consist of the IPC and components necessary for its' use such as convenience kits to aid in the implantation of the Rocket IPC.

The Rocket IPC System, a fenestrated silicone drainage catheter for pleural effusions, underwent performance testing in accordance with applicable FDA Guidance documents and ISO standards. The device demonstrated satisfactory performance against predefined acceptance criteria for various physical and functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

For the performance tests listed in the table, a sample size of 3 devices was used for each test. The document does not specify the country of origin of the data or whether the study was retrospective or prospective, as these were bench tests performed on the device itself.

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

This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not an adjudication process by human experts.

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

An MRMC comparative effectiveness study was not conducted. The document describes bench testing for device performance and a comparison of technological characteristics to a predicate device, but not a study involving human readers with and without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

This information is not applicable as the device is a physical medical device (catheter system), not an algorithm or AI system. The performance tests focused on the device's physical and functional properties.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests was established by objective, measurable criteria defined in referenced international and national standards (e.g., EN 1617:1997, EN 1618:1997, ASTM F1980). These standards define the acceptable performance limits for the device's physical and functional characteristics.

8. Sample Size for the Training Set:

This information is not applicable as the submission describes a physical medical device and its bench testing, not an AI or algorithm-based device that would require a training set.

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

This information is not applicable for the reasons stated above.

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For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies.

For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

CerviNeedle™ Disposable Cartridge Syringe

The provided text is a 510(k) summary for the Rocket Medical plc CerviNeedle™ Disposable Cartridge Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert qualifications are not present in this document.

Here's an analysis based on the provided text:

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

No explicit acceptance criteria or detailed performance data against them are provided in the 510(k) summary. The summary states:

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

Not provided. The 510(k) summary does not describe a performance study with a test set.

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 provided. The 510(k) summary does not describe a performance study that involved experts establishing ground truth for a test set.

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

Not applicable. No performance study requiring adjudication 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 manual cartridge syringe, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

Not applicable. This is a manual medical device, not an algorithm.

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

Not applicable in the context of a performance study for this device. The "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable. This device does not use machine learning or require a training set.

Summary of Safety and Effectiveness Information Presented (from the document):

The 510(k) submission for the CerviNeedle™ Disposable Cartridge Syringe relies on demonstrating substantial equivalence to existing predicate devices. The key elements are:

• Substantial Equivalence: The device is deemed substantially equivalent to the CooperSurgical Inc Potocky Needle™ Disposable Injection Needle (#K910252), Wallach Surgical Devices Inc, Endocervical Block Needle (#K021224), and A & A Medical Inc, Endocervical Block Needle (#K973671).
• Basis for Safety and Effectiveness: The conclusion of safety and effectiveness is drawn from "indications for use, technical characteristics and comparison to currently commercial marketed devices." This implies that because the device is technically similar and intended for the same uses as already approved devices, it is considered safe and effective.
• Ongoing Monitoring: Rocket Medical plc states they "continue to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information." This indicates a post-market surveillance commitment rather than detailed pre-market study data in the 510(k).

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The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

The provided text is a 510(k) summary for the Rocket Medical plc IR™ Guidewires, dated November 2, 2004. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based diagnostic or assistive device.

Instead, it pertains to a physical medical device (guidewires) and focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are relevant to the evaluation of AI/machine learning devices, not a traditional physical medical device like guidewires in this context.

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The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:

• For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
• Hormone therapy monitoring. .
• Endometrial dating .
• Detection of endometrial carcinoma .
• Bacterial culturing .

This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.

The provided document set describes the Rocket Medical plc Endometrial Sampling Syringe, which was submitted for 510(k) clearance. This means the device demonstrated substantial equivalence to a predicate device already on the market, rather than proving its safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies is largely inapplicable or not detailed in this specific submission.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of a 510(k) submission focused on substantial equivalence:

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

For a 510(k) submission, the "acceptance criteria" are typically related to demonstrating equivalence in design, materials, and intended use to a predicate device. "Reported device performance" in this context refers to the comparison against the predicate, primarily on physical characteristics.

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

• Sample Size: Not applicable. The submission states, "The device has yet to be clinically evaluated but has been subjected to a real laboratory performance testing against competitor product." This indicates in vitro or bench testing, not human subject testing with a "test set" in the sense of clinical data. There is no information on the number of samples used in this laboratory testing.
• Data Provenance: The device is manufactured by Rocket Medical plc in Tyne & Wear, England. The laboratory performance testing would have been conducted internally or by a contracted lab. The data is likely non-clinical/bench test data, not patient 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 described, no clinical "test set" with human subjects requiring expert ground truth establishment was used for this 510(k) submission. The evaluation was laboratory-based comparison to a predicate device.

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

Not applicable. No clinical "test set" with human subjects requiring adjudication was used.

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 an endometrial sampling syringe, not an AI-assisted diagnostic tool or a device that impacts human reader performance. 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 a medical device (syringe), not an algorithm or AI system.

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

Not applicable. For the in vitro or bench testing, the "ground truth" would be the measurable physical and functional specifications of the predicate device, against which the new device was compared. For example, comparing the actual sampling hole size of the Rocket syringe to the stated size of the Unimar Pipelle. There's no pathological, outcomes, or expert consensus ground truth mentioned for this type of submission.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

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Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers.

For use in ultrasound guided oocyte harvesting and tissue biopsy.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

Re-usable ultrasound needle guides have been in use for over 20 years. The device is safe and effective for the application for which it is intended. More recently concerns about cross infection and patient pain have produced some single use versions being in use for the past 3 years, without any known incident in the UK.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) premarket notification summary for the Embryon® Ultrasound Needle Guide, primarily focused on establishing substantial equivalence to legally marketed predicate devices.

The summary states that "The device is safe and effective for the application for which it is intended" and mentions that "Re-usable ultrasound needle guides have been in use for over 20 years" and "single use versions being in use for the past 3 years, without any known incident in the UK." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document is a regulatory submission for market clearance, not a clinical study report.

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