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To create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management.

The new kit is designed to permit percutaneous creation of a tracheostomy stoma and subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. It employs the well understood and established procedure for dilating a stoma and introducing the tracheostomy tube using the Seldinger over a guide wire system. The kit contains all of the standard components to which the user are accustomed: scalpel, needle and cannula, syringe, guidewire, guiding catheter, Gauze pads, short pre-dilator, dilator system, and tracheostomy tube introducers. The kit differs from the above two kits in that it employs a single tapered dilator to replace the multiple serial dilators. The packaging is the same as that used in K022212. It is designed with an outer blister, which contains an inner tray. The tray layout is designed to present the user with the components in the order of use. Each pack is EO sterilised and individually packed in a carton together with the directions for use.

The provided text is a 510(k) summary for a medical device (Percutaneous Dilation Tracheostomy Kit) and a letter of substantial equivalence from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as typically found in an AI/ML device submission.

The document describes a physical medical device and its equivalence to predicate devices, focusing on its design, intended use, and regulatory classification. It does not involve any AI/ML components or performance metrics related to diagnostic accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested table and study details based on the input text.

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The Portex Reinforced Tracheal Tubes (cuffed and uncuffed) are designed for oral or nasal intubation for airway management during anaesthesia. The product may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.

Single use. A Tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen. The Portex Ltd PVC, Single-use Reinforced tracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gases are directed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric applications who require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The reinforced tracheal tube (Cuffed Murphy eye) is available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm only. The reinforced tracheal tube (Uncuffed) is available in sizes 3.0, 3.5, 4.0, 4.5 and 5.0mm only.

This document is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial publication. Therefore, much of the requested information regarding a device meeting specific acceptance criteria through a dedicated study is not present in this submission.

However, I can extract the available information and explain why other details are missing based on the nature of a 510(k) submission.

Analysis of the Provided Text and Missing Information:

The document describes the Portex Ltd. PVC, Single Use Reinforced, Oral/Nasal Endotracheal Tube. It details the device, its intended use, and compares its technological characteristics to several predicate devices to establish substantial equivalence.

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

This information is not explicitly present in the provided 510(k) summary. A 510(k) submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics (materials, design, performance standards) rather than reporting against specific, pre-defined acceptance criteria from a new, comprehensive performance study that would generate detailed performance metrics like sensitivity, specificity, accuracy, etc.

The document states:

• "TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:" section, which lists comparisons of materials, design (reinforced tube, cuff, print markings, inflation line, pilot balloon, connector) between the proposed device and various predicate devices. This implicitly suggests that the acceptance criteria are met if these characteristics are deemed equivalent to existing, safely marketed devices.
• "PERFORMANCE / CLINICAL DATA: Performance data for the proposed device is shown in Section 8.0 Performance." However, Section 8.0 is not included in the provided text. This section would likely contain the specifics of any performance testing conducted. Without it, we cannot create a table of acceptance criteria and reported device performance.

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

This information is not available in the provided text. Since the document is a 510(k) summary focused on substantial equivalence, it does not typically detail the specifics of clinical trial design, sample sizes for test sets, or data provenance in the way a research paper would. If performance data were included in the unprovided Section 8.0, it might contain some of this information, but it's not guaranteed to be as detailed as requested.

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)

This information is not applicable/available from the provided text for the following reasons:

• The device is an endotracheal tube, a mechanical device. Its performance is typically evaluated through engineering tests (e.g., tensile strength, kink resistance, material biocompatibility) and sometimes limited clinical observations, not through image interpretation or diagnostic tasks that would require "ground truth" established by experts in the context of diagnostic accuracy.
• The 510(k) process for such devices relies on demonstrating equivalence to predicate devices, often through non-clinical bench testing and material characterization, rather than extensive clinical studies requiring expert consensus on "ground truth."

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

This information is not applicable/available for the same reasons as point 3. Adjudication methods are relevant in studies where human interpretation of data is involved and a consensus or tie-breaking mechanism is needed to establish ground truth or evaluate diagnostic performance, which is not the primary mechanism for evaluating an endotracheal tube in a 510(k) submission.

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/available.

• The device is a physical medical device (endotracheal tube), not an AI-powered diagnostic tool or imaging software.
• Therefore, an MRMC study and the concept of "human readers" improving with AI assistance are irrelevant to this device.

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

This information is not applicable/available for the same reasons as point 5. This device is not an algorithm.

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

This information is not applicable/available for the same reasons as point 3. The evaluation of this device would involve engineering specifications, biocompatibility testing, and potentially some clinical observation of device function (e.g., ease of insertion, kink resistance in use), rather than ground truth in the diagnostic sense.

8. The sample size for the training set

This information is not applicable/available. The device is not a machine learning model, so there is no "training set."

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

This information is not applicable/available for the same reasons as point 8.

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Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.

Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter

Embryo Replacement Catheters: The Embryo Replacement Catheters (for use in ultrasound-guided transfers) are single use devices for the introduction of embryos into the uterine cavity following in-vitro fertilisation. The devices have overall lengths; 18cm (CE 118A) and 23cm (CE 123A) and consist of a soft, flexible inner cannula, with end opening, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a lumen that is uniform throughout its length, with a series of 1cm graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.

Trial Transfer Catheters: The Trial Transfer Catheters (for use in ultrasound-guided transfers) are single use devices used to assess the passage through the cervix prior to embryo transfer. The devices have overall lengths; 18cm (CE 418A) and 23cm(CE 423A) and consist of a flexible inner cannula, with blind end, and a detachable outer sheath that is attached to the inner catheter by a Luer taper. The inner catheter is of dimensions 1.5mm (OD) x 0.76 mm(ID) with a series of graduations at the proximal end. The inner catheter protrudes from the outer sheath by 5cm and the outer sheath has a series of 1cm graduations at the distal end.

The provided text is a 510(k) premarket notification for a medical device, the Wallace (Sure View TM) Embryo Replacement Catheters & Trial Transfer Catheters. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies proving efficacy and safety with specific acceptance criteria as you might find for a novel device.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance derived from a study proving the device meets those criteria. Specifically, it lacks:

• Explicit Acceptance Criteria: The document does not define specific performance metrics (ee.g., sensitivity, specificity, accuracy, precision, etc.) that the device must meet, nor does it quantify acceptable thresholds for these metrics.
• A "Study" in the traditional sense: There isn't a prospective or retrospective clinical trial described with a defined protocol, recruitment, data collection, and statistical analysis to assess the device's performance against pre-defined criteria.
• Reported Device Performance: Since there's no study, there are no reported numerical performance results for the device.

Instead, the submission relies on the concept of substantial equivalence. The performance section states: "Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects." This implies that the device's performance characteristics are considered to be similar enough to the predicate devices that no new robust performance studies are deemed necessary by the submitter or the FDA (as indicated by the clearance letter).

Here's a breakdown of why the requested information isn't available in the provided text, and what information is present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) for a substantially equivalent device, the "acceptance criteria" are implicitly that the device performs as well as or similarly to the predicate device, especially for its intended use and any new technological characteristics. Here, the key technological difference is enhanced ultrasound visibility, which is stated to be substantially equivalent to another predicate (Cook Echotip®). The "study" proving this is a comparison to the predicate devices rather than a de novo clinical trial with specific performance endpoints.

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

• Not Applicable / Not Provided: The document does not describe a clinical "test set" or a study involving patient data to assess performance. The comparison for substantial equivalence appears to be based on design, material, and manufacturing similarities, and the inherent properties of the enhanced ultrasound visibility material compared to a similar predicate.

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

• Not Applicable / Not Provided: There is no clinical "test set" and therefore no ground truth established by experts described in this submission.

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

• Not Applicable / Not Provided: No test set or adjudication method 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

• No: This is a submission for a physical medical catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study with AI assistance is not relevant and was not performed.

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

• No: This is a physical medical catheter, not an algorithm, so a standalone performance study in this context is not applicable.

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

• Not Applicable / Not Provided: No ground truth in the context of clinical performance assessment is described, as the submission focuses on substantial equivalence based on material, design, and intended use comparison to predicate devices. The "ground truth" for clearance in this context is the FDA's determination that the new device is as safe and effective as the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable / Not Provided: As there is no AI component or machine learning model, there is no "training set" in the context of this device.

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

• Not Applicable / Not Provided: No training set is described.

Summary of what the document does provide regarding the "study":

The "study" in this 510(k) context is a demonstration of substantial equivalence to predicate devices. The key comparison for performance relates to the enhanced ultrasound visibility. The submission states:

• "The proposed devices are made from the same materials as Predicate 1 & 2. with the exception that the material is modified to enhance the visibility of the catheter under ultrasound. In this respect, the inner catheter is substantially equivalent to Predicate 3 [Cook Echotip® Soft-Pass Embryo Transfer Catheter already marketed in the USA under K983594]."
• "Comparison of the performance of the proposed device with the predicate confirms substantial equivalence in all aspects."

This indicates that the "proof" the device meets implied performance criteria (i.e., being safe and effective for its intended use, particularly with enhanced ultrasound visibility) is based on:

1. Material and design similarity: The proposed device's physical characteristics (tip protector, outer sheath, print markings, hubs) are identical or substantially equivalent in material composition and profile to existing predicate devices (Wallace Embryo Transfer Catheter, K990350; Wallace Trial Transfer Catheter, K990348).
2. Comparison of enhanced feature to an already cleared predicate: The ultrasound visibility feature is deemed substantially equivalent to another predicate that already possesses such a feature (Cook Echotip® Soft-Pass Embryo Transfer Catheter, K983594).

No new clinical trials with specific performance endpoints were required or conducted as part of this 510(k) submission.

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The Thermovent HEPA HME breathing system filter provides bacterial and viral filtration protecting the patient and the breathing circuit or ventilator. It also provides passive heat and humidification to the patient.

The Thermovent HEPA (High Efficiency Particulate Air) HME (Heat and Moisture Exchange) breathing system filter is a single use bacterial and viral filter with 'HEPA' grade filtration properties. The filter is intended for use with ventilators, anaesthesia breathing circuits, positive breathing systems and passive spontaneous breathing intubated patients. The Thermovent HEPA is a hydrophobic filter, which acts as an effective barrier to both air and liquid borne contaminates. The filter media repels liquid and therefore prevents any liquid moving from the patient side of the device through to the ventilator circuit. To maximise the filtration surface area, the filter media is pleated before assembly into the filter housing. The Thermovent HEPA also acts as a passive, hydrophobic humidifier. The expired gasses from the patient condense on the surface of the media, while releasing latent heat and warming the filter element. On inspiration, the airflow is warmed by the filter element, while the liquefied water is vaporised, thus allowing humidified air to be returned to the patient. The Thermovent HEPA has a Luer port on the machine side of the housing to allow monitoring of the patients gasses, after filtration. The filter housing also features a peg where the user can park the gas sampling port is in use. The devices are packed individually in flexible thermoformed pouch type unit packs.

The provided document does not contain a study or detailed acceptance criteria for a device's performance. Instead, it is a 510(k) summary and FDA clearance letter for the Portex Thermovent HEPA HME Breathing Filter.

The document indicates that the device's performance was evaluated against a set of voluntary standards rather than through a specific clinical or performance study with defined acceptance criteria and statistical analysis.

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

However, I can extract the information related to the standards the device complies with, which implicitly serve as its performance "acceptance criteria" in the context of this 510(k) submission.

Here's what can be extracted based on the provided text, focusing on the compliance with standards:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information (2-9), the document does not provide these details as it describes compliance with existing standards rather than a de novo study:

• 2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to compliance with standards, which would involve specific tests defined by those standards, but the sample sizes for those tests are not detailed here. Data provenance is not specified.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable/Not provided, as there was no "ground truth" to establish in the context of a study described here. Compliance with standards is typically verified by testing laboratories.
• 4. Adjudication method for the test set: Not applicable/Not provided.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any comparison of human readers with/without AI assistance.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical filter, not an AI algorithm.
• 7. The type of ground truth used: Not applicable. The "ground truth" here is compliance with the specifications and performance requirements outlined in the cited standards.
• 8. The sample size for the training set: Not applicable/Not provided. This is not an AI device with a training set.
• 9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary: The provided text is a 510(k) summary demonstrating substantial equivalence by showing compliance with recognized performance standards, not a report of an independent clinical or performance study with detailed acceptance criteria, ground truth establishment, or human-in-the-loop evaluations.

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The Portex Blue Line Ultra Suctionaid Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid allows aspiration of mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.

The Blue Line Ultra Suctionaid (BLUS) tracheostomy tube provides an airway to the patients lungs when the upper airway / larynx / pharynx or oral & nasal routes are occluded or compromised due to traumatic injury, illness, or during surgery, and is elective for long term ventilated patients. The tube can be used for ventilated, or spontaneously breathing patients. The BLUS is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLUS is cuffed. The cuff provides a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. BLUS has a clear suction line terminating with a suction orifice above the cuff which allows any pooled secretions to be aspirated. The suction line terminates with a connector for suction devices and a Luer port to connect to either a syringe or a vacuum control valve which is included in the pack. The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent. The BLUS is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the stoma site for tube change insertion. The BLUS tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula, Tracheostomy tube disconnection wedge, cleaning brush and a patient notes label. The change kit includes a tube change J tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO. Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.

The provided text is a 510(k) summary for the Portex Ltd. Blue Line Ultra Suctionaid Tracheostomy Tube. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria with specific metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics are not present in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size (Test Set): Not specified. The document refers to "Performance data for the proposed device is shown in section 8.0 Performance," but Section 8.0 is not included in the provided text. The submission relies on comparison to predicate devices, not specific clinical trial data with a defined test set.
• Data Provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence, the "study" is primarily a comparative analysis against existing devices in terms of design, materials, and intended use, rather than a prospective clinical study generating new data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/Not specified. Ground truth as typically understood for AI models (e.g., expert consensus on images) is not relevant here. The evaluation is based on engineering design, material properties, and comparison to legally marketed predicate devices.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable/Not specified. This type of adjudication is typically for diagnostic interpretation studies, which is not the nature of this 510(k) submission.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This document is for a physical medical device (tracheostomy tube), not an AI diagnostic/interpretive tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No, a standalone algorithm performance study was not performed. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and the demonstration that the proposed device is substantially equivalent in its design, materials, and intended use. This is primarily an engineering and regulatory comparison rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for Training Set

• Sample Size (Training Set): Not applicable/Not specified. This concept is for AI/ML models, not for the regulatory approval of a physical medical device through a 510(k) pathway.

9. How Ground Truth for Training Set was Established

• How Ground Truth was Established: Not applicable. (See #8).

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Portex Blue Line Ultra Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

The Blue Line Ultra (BLU) tracheostomy tube provides an airway to the patients lungs when the upper airway / larynx / pharynx or oral & nasal routes are occluded or compromised due to traumatic injury, illness, or during surgery, and is elective for long term ventilated patients. The tube can be used for ventilated, or spontaneously breathing patients. The BLU is available in sizes 6.0, 7.0, 7.5, 8.0, 8.5 and 9.0mm only. BLU is available in cuffed and uncuffed variants. The cuff provides a seal against the trachea, ensuring that inspiratory and expiatory gasses are routed through the tube and not allowed to escape to the patients upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration. The outer tube can be used with or without an inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent. The BLU is supplied pre-loaded onto an obturator. The obturator reduces the risk of the distal end of the product from damaging the trachea upon insertion. The obturator has an internal pathway for a guide wire, so that a guide wire can be used to help position the tube through the stoma site for tube change insertion. The BLU tracheostomy tube is packed in several kit variants to suit clinician preferences. Each kit contains a tracheostomy tube holder, an inner cannula cleaning brush, disconnection wedge and a patient notes label. The change kit includes a tube change i tip guide wire. This wire is used to help place a second tracheostomy tube in a pre-existing stoma when the first tube needs to be changed. Each kit is individually packed in a blister and shelf carton (tracheostomy tube holder and cleaning bush packed outside of the blister in a polyethylene bag), and the products are sterile by ETO. Replacement Blue Line Ultra inner cannula are available in packs of 20 or 50. The cannula are individually packed in a blister to maintain sterility, and contained within a shelf carton. The inner cannula lines the bore of the outer tube, and can be removed, cleaned and replaced to ensure that the bore of the tube is kept patent.

This document is a 510(k) summary for the Portex Ltd. Blue Line Ultra Tracheostomy Tube. It details the device's description, intended use, and comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain acceptance criteria or a study proving device performance against such criteria in the manner of a clinical trial or performance study with quantified metrics.

The document states: "Performance data for the proposed device is shown in section 8.0 Performance." but Section 8.0 is not included in the provided text. Without Section 8.0, it is impossible to provide the requested information about acceptance criteria and performance data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory filing (510(k)) focused on establishing substantial equivalence to existing devices, not presenting the results of a standalone performance study with detailed metrics and statistical analysis.

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The Wallace Dual Lumen Oocyte Retrieval Sets are sterile single-use devices for ultrasonic-guided transvaginal collection of oocytes from the ovarian follides.

The Wallace Dual Lumen Oocyte Retrieval Sets are sterile, single-use devices for ultrasound ~ guided transvaginal collection of Oocytes from ovarian follicles. The set consists of a dual-lumen stainless needle attached to polyurethane tubing. The needle is 33cm in length and available in 16 gauge or 17 gauge sizes, each having 1cm of echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Retrieval tubing is attached to the proximal end of the hub and is available in two lengths, protruding a total distance of either 60cm, 75cm or 95cm until it passes through a silicone bung. The Retrieval tubing is sleeved at the needle connection with a silicone sleeve (Blue 16g). Flushing tubing is attached to the top of the hub and extends to either 60cm, 75cm before it terminates in a clear female luer connector. A pump adapter component is included in each pouch pack to allow connection of the pink female Luer connector to vacuum tubing with an internal diameter of between 4 and 10.5mm.

The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for the "Wallace Dual Lumen Oocyte Retrieval Set," focusing on its substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested information.

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Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.

A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.

The provided text describes the 510(k) summary for the Portex Ring Pessary, which is a medical device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert adjudication, or MRMC comparative effectiveness studies.

The document primarily focuses on:

• Device Identification: Applicant, name, classification, predicate device.
• Device Description and Intended Use: What it is, what it's for, contraindications, and warnings.
• Technical Characteristics: Mentions that "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use" and lists "Visual and Dimensional" tests.
• Data Submitted (Safety): States that a biological safety assessment was performed in accordance with ISO 10993, Part 1:1994.

Therefore, I cannot provide the requested table and study details as the information is not present in the given text.

Summary of what can be extracted (and what cannot):

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated. The document mentions "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device" including "Visual and Dimensional" tests, and biological safety per ISO 10993. No specific quantifiable criteria or pass/fail thresholds are given.
• Reported Device Performance: No specific performance metrics or results (e.g., success rate in preventing prolapse, reduction in stress incontinence) are provided.

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

• Sample Size: Not mentioned for any performance or efficacy testing.
• Data Provenance: Not mentioned.

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

• Not mentioned. The document relies on pre-clinical testing and comparison to a predicate device, not clinical studies with expert-established ground truth.

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

• Not applicable/Not mentioned, as there is no described test set requiring adjudication in the context of clinical performance or diagnostic accuracy.

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 pessary, not an AI-assisted diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

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

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

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

• For biological safety, the ground truth would be established by the ISO 10993 standards and associated laboratory tests.
• For physical characteristics (visual and dimensional), the ground truth would be engineering specifications and quality control measurements.
• No "ground truth" equivalent to what would be used for a diagnostic device (e.g., pathology for cancer detection) is described for this product.

8. The sample size for the training set:

• Not applicable/Not mentioned. There is no "training set" as this is a physical device, not a machine learning model.

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

• Not applicable.

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The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles.
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.

Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.

The Wallace Oocyte Retrieval Set is a medical device and therefore its acceptance criteria is based on safety and efficacy rather than performance metrics like sensitivity or specificity.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify a distinct test set or sample size for each performance test. The device is a "set" implying multiple components and likely multiple units were subjected to these tests. Given the 2001 date, it is highly probable that all testing was retrospective and conducted in the UK, where the applicant (SIMS Portex Ltd) is located.

3. Number of Experts and Qualifications

No information is provided regarding the number or qualifications of experts involved in establishing acceptance criteria or interpreting test results. The implication is that internal company experts conducted and assessed the tests.

4. Adjudication Method

No formal adjudication method is described. The acceptance appears to be based on the internal assessment of the conducted tests.

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

Not applicable. The Wallace Oocyte Retrieval Set is a medical device, not an AI or imaging diagnostic tool that would typically involve a multi-reader, multi-case study.

6. Standalone (Algorithm Only) Performance

Not applicable. The Wallace Oocyte Retrieval Set is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth for acceptance appears to be established by adherence to internal company-developed tests and the ISO 10993 standard for biological safety, rather than external expert consensus, pathology, or outcomes data in the context of diagnostic accuracy. The "two-cell Mouse Embryo Assay" provides a biological ground truth for embryo toxicity.

8. Sample Size for Training Set

Not applicable. The device is not an AI model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable.

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