Search Results

Holder for electrosurqical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

The Quiver Laparoscopic Extendable is a telescoping instrument holder comprised of two separate parts. One component (the outer or top component) has two open ends and the other component has one open end and one closed end. It is provided assembled and sterile, allowing compact storage and shipment then extension by the user to hold long surgical instruments. After use, the device can be collapsed for compact disposal. A loop handle attached to the top can be used for hanging the device in a convenient place.

This document is a 510(k) premarket notification for a medical device called the "Quiver Laparoscopic Extendable." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets a specific set of acceptance criteria through a full-scale clinical trial in the way a novel AI algorithm might. Therefore, many of the requested items related to "study" and "ground truth" are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific quantitative thresholds that the device was required to meet, as would be typical for an AI algorithm. Instead, it lists various evaluations and tests conducted to ensure the device's safety and functionality in comparison to a predicate device. The performance is described qualitatively.

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

The document does not specify a distinct "test set" in the context of clinical data for an AI/algorithm, as this is a physical medical device. The "tests" performed (e.g., Extension/Collapsing Test, Drop Test, Packaging Integrity Test) would involve a sample size of the manufactured device units, but these specific numbers are not provided.

The "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven device.

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

Not applicable. This device does not involve expert-established ground truth in the way an AI diagnostic tool would. The ground truth for functional product testing is typically based on engineering specifications and validated test methods.

4. Adjudication method for the test set

Not applicable. There's no adjudication in the sense of expert review for diagnostic agreement in this context.

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 a physical instrument holder, not an AI-assisted diagnostic or treatment device.

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

Not applicable. This is a physical instrument holder, not an algorithm.

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

The "ground truth" in this context is based on:

• Engineering Specifications: For dimensional measurements, assembly, and functional parameters.
• International Standards: Such as ISO 11135:2007 for sterilization validation, and EN ISO 14971:2012 for risk management.
• Material Science Principles: For biocompatibility and thermal resistance.
• Internal Quality Control Procedures: For visual inspection and various in-house tests.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve AI model training.

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

Not applicable. This is a physical device and does not involve AI model training.

Summary of the Study (Performance Data):

The document describes the following evaluations and tests performed on the Quiver Laparoscopic Extendable:

• Visual inspection and dimensional measurement of all molded components: To ensure parts meet design specifications.
• Full assembly physical inspection and measurement: To verify proper assembly and final dimensions.
• Extension/Collapsing Test: To confirm the device's ability to extend and collapse as intended.
• Application Test: To verify its function as an instrument holder.
• In-house Drop Test: To assess the device's durability under typical handling conditions.
• Packaging Integrity Test: To ensure the sterility barrier and physical protection of the device during transport and storage.
• Accelerated aging test (real-time aging test ongoing): To predict shelf-life and material stability over time.
• Biocompatibility testing: For hemocompatibility, cytotoxicity, sensitization, irritation, and systemic injection of the material, even though it's not a patient-contact device.
• ETO sterilization method validation: According to ISO 11135:2007 Sterilization of Health Care Products, achieving a Sterility Assurance Level (SAL) of 10^-6.
• Risk evaluation: Conducted in accordance with EN ISO 14971:2012 (Risk Management) and EN 62366:2008 (Usability Engineering), leading to the definition and implementation of mitigation measures for identified risks.

The overall "study" is a collection of engineering and material verification tests aimed at demonstrating that the device is safe and performs as intended, and importantly, is substantially equivalent to the predicate device. These tests, rather than a clinical trial, are the basis for the FDA's 510(k) clearance for this type of device.

Ask a specific question about this device

The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests.

Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.

This document details a Special 510(k) Summary for a medical device called the ITL SampLok® Luer Kit. A Special 510(k) is used for modifications to a manufacturer's own legally marketed device. In this case, the modification is the pre-attachment and co-packaging of two previously cleared devices: the SampLok® Needle Holder and the Nipro Luer Adaptor.

The core of a Special 510(k) relies on demonstrating that the modification does not introduce new risks or alter the fundamental safety and effectiveness of the device as previously cleared. Therefore, the "acceptance criteria" and "study" are not presented in the traditional sense of a de novo device submission with extensive clinical trials. Instead, the demonstration revolves around showing that the modified device's performance is either identical to or within the established safety and effectiveness parameters of its predicate components.

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

Acceptance Criteria and Device Performance for ITL SampLok® Luer Kit

The provided document describes a Special 510(k) Summary for the ITL SampLok® Luer Kit. For a Special 510(k), the "acceptance criteria" and "device performance" are typically demonstrated by showing that the modified device's technical characteristics and intended use are identical or substantially equivalent to its legally marketed predicate components, and that the modification (pre-attachment and co-packaging) does not negatively impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on a specific test set, its sample size, or data provenance in the context of a performance study. For a Special 510(k) regarding the pre-attachment of two already cleared devices, the "proof" primarily relies on:

• The fact that the individual components have already been cleared and demonstrated safety and effectiveness (their "test sets" and data would have been part of their original 510(k)s).
• Justification that the act of pre-attaching and co-packaging does not alter the fundamental characteristics or introduce new risks. This typically involves engineering analysis, risk assessments, and perhaps basic functional testing if deemed necessary, rather than a large-scale performance study.

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

Not applicable. As noted above, there is no mention of a traditional "test set" requiring ground truth establishment by experts in this Special 510(k) summary. The reliance is on the prior clearance of the individual components.

4. Adjudication Method for the Test Set:

Not applicable. No test set or ground truth adjudication described.

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

Not applicable. This type of study assesses human reader performance, typically with image interpretations or similar diagnostic tasks. The ITL SampLok® Luer Kit is a physical medical device for blood collection; therefore, an MRMC study is not relevant to its clearance.

6. Standalone Performance Study:

Not applicable in the traditional sense of an algorithm's standalone performance. The "standalone performance" of the ITL SampLok® Luer Kit is inherent in the demonstrated performance and clearance of its individual components (SampLok® Needle Holder and Nipro Luer Adaptor). The Special 510(k) argues that packaging them together does not diminish this performance.

7. Type of Ground Truth Used:

Not applicable. The clearance is based on the substantial equivalence of the components and the lack of new risks from the packaging modification, rather than performance against a specific "ground truth" derived from patient outcomes or pathology.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set.

Ask a specific question about this device

The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.

The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.

This K021017 document is a 510(k) summary for a medical device called the LeeSpec™ Disposable Vaginal Speculum. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.

Therefore, the "acceptance criteria" for this device are primarily based on its substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the 510(k) summary itself, which highlights the similarities to the predicate device.

Here's an analysis of the provided information relative to your requested categories:

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

For a 510(k) of this nature, the "acceptance criteria" are not performance metrics in the way one might think of a diagnostic test (e.g., sensitivity, specificity). Instead, they are the criteria for substantial equivalence to the predicate device. The "reported device performance" is the statement that the characteristics of the new device match those criteria.

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

• This 510(k) summary does not describe an analytical or clinical study with a "test set" in the traditional sense of evaluating performance metrics. It's a comparison to a predicate device.
• Therefore, there is no sample size for a test set, no data provenance, and no retrospective or prospective study mentioned in this document. The "data" here is the descriptive information of the device and its comparison to the predicate.

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)

• As there is no traditional "test set" or clinical study, there are no experts mentioned in this document as being used to establish ground truth. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate device.

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

• None mentioned, as there was no formal "test set" 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

• No MRMC study was done. This device is a physical speculum and does not involve AI or human readers in the context of diagnostic interpretation.

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

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

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

• For this type of device and 510(k) submission, the "ground truth" for performance is the established safety and effectiveness of the legally marketed predicate device (Medisul Disposable Vaginal Speculum K000414), which serves as the benchmark against which the new device is compared. The expectation is that because the new device is substantially equivalent in its design, materials, and intended use, it will have similar performance characteristics to the predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an algorithm being developed or a clinical trial in the sense of patient enrollment for a new treatment.

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

• Not applicable. No training set was used.

Ask a specific question about this device

Ask a specific question about this device

The AV Fistula Needle Protector (AVFNP) is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures.

The AV Fistula Needle Protector (AVFNP) is a disposable, single-use, non-sterile needle protector, which is used as an aid in preventing accidental needle stick injuries upon completion of hemodialysis and apheresis procedures. The design of the AVFNP is compatible with currently marketed AV Fistula needle sets produced by most major manufacturers.

The hinged assembly allows the AVFNP to be included on AV Fistula needle sets at the time of manufacture or during a hemodialysis or apheresis procedure (i.e., before needle insertion or just prior to withdrawal). Once the AVFNP is clipped over the tubing, it can be engaged at any time by moving the AVFNP down the tubing to rest behind the butterfly wings of the AV Fistula needle. Prior to withdrawal of the needle, the AVFNP should be held securely between the index finger and thumb while the other hand pulls the tubing and needle assembly into the AVFNP. This position shields the point of the needle. A lock, an additional safety feature, can be activated once the needle has been shielded by pressing the top and bottom of the AVFNP together. This lock restricts further access to the needlepoint and contains any blood that may drop from the needle. An audible click can be heard when the lock is activated.

The AVFNP can be operated with either hand and leaves the other hand free to apply pressure to the puncture point and/or stabilize the AVFNP while withdrawing the needle. The AVFNP can be stabilized by holding, between the index finger and thumb, either the ribbed area on the front (e.g., when health care professional applies pressure to the puncture site during withdrawal of the needle) or the thumb rest on the back (e.g., when patient applies pressure to the puncture site during withdrawal of the needle).

The provided document is a 510(k) summary for a medical device called the "AV Fistula Needle Protector (AVFNP)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and detailed study designs as might be found for a novel, higher-risk device.

Therefore, the information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance, is not typically included or required in a 510(k) submission like this. The regulatory pathway for this device (Class II) allows for substantial equivalence based on comparison to predicate devices, focusing on technological characteristics, intended use, and materials.

Here's a breakdown of why many of your excellent questions cannot be answered by this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish new, quantitative acceptance criteria for performance beyond demonstrating that its specifications (e.g., dimensions allowing complete encapsulation and preventing finger access) are "adequate" and "same" as the predicate. It relies on the predicate devices already having met such criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No dedicated "test set" or clinical study with human or simulated data is described for the AVFNP in this summary. The comparison is primarily based on design and materials.

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 there is no test set requiring expert ground truth for specific medical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.

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 physical needle protector, not an AI or imaging diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable, as there is no "training set" for an algorithm.

9. How the ground truth for the training set was established: Not applicable.

However, I can extract the relevant information regarding the basis for acceptance for the AV Fistula Needle Protector (AVFNP) within the context of a 510(k) submission:

Basis for Acceptance (Substantial Equivalence):

The device gained acceptance based on its substantial equivalence to existing legally marketed predicate devices, specifically the Bloodpack Needle Protector (BNP) (BK980008) and the Medisystems Apheresis Needle with Guard (K932074).

1. Table of Acceptance Criteria and Reported Device Performance (as demonstrated through substantial equivalence):

Reported Device Performance (based on comparison):
The document states, "The intended use, design, materials of fabrication, and performance are the same as the predicate devices..." This implies that the AVFNP performs equivalently to the predicates in preventing needle stick injuries because its fundamental characteristics match those of previously cleared devices for the same purpose. The details about its operation (hinged assembly, locking mechanism, one-handed operation) further describe its designed functionality.

Summary of Study Information (or lack thereof, due to 510(k) pathway):

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or clinical data is detailed for the AVFNP in this summary. The "testing" mentioned under 'Specifications' refers to internal verification that the device dimensions adequately covered various needle sizes, implied to be laboratory-based rather than a clinical study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/imaging device).
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for the substantial equivalence determination is the existing regulatory clearance and presumed safety/effectiveness of the predicate devices based on their own prior reviews.
• 8. The sample size for the training set: Not applicable (no algorithm).
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device