Search Results

The Gynex brand Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix.

The CO-1000 Colposcope is a precise optical instrument designed specially for the gynecologic examination. The Gynex brand colposcope can be used to view vaginal and cervical tissues using stereoscopic optics. The Gynex CO-1000 Colposcope has detailed features that include wide field of view, long focal length, uniform illumination, adjustable brightness, ease of operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece magnification: 12.5X. Overall Magnification: 9X Focal length: 320mm. Individually adjustable evepieces. Smooth adjustable controls for fine focus. Universal Teflon ball joint gives you 360° easy motion for gross focus. Built-in green filter for enhanced contrast. Built-in rheostat. Easy replacement of halogen light bulb. Unit is completely assembled and ready for use once power is on.

The provided text describes a 510(k) Premarket Notification for the CO-1000 Colposcope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical studies and acceptance criteria. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets said criteria in the way one might expect for a novel device or a Premarket Approval (PMA) application.

Instead, the submission asserts that the CO-1000 Colposcope is substantially equivalent to the DFV CPG Colposcope (K021854). Substantial equivalence is established by comparing the device's intended use, basic design, materials, method of manufacture, physical dimensions, and clinical utility to the predicate device.

Given this, I cannot extract the specific information requested in your prompt regarding acceptance criteria and studies demonstrating their fulfillment, as this information is not part of this 510(k) summary.

However, I can provide available information based on the document's content:

Summary of Device Information based on 510(k) Submission:

The GYNEX CO-1000 Colposcope is a Class II device intended for direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina, used to diagnose abnormalities and select areas for biopsy.

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

• This document does not define specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or examination.
• The "performance" described relates to the device's functional features (e.g., magnification, focal length, illumination) and its claim of substantial equivalence to a predicate device.

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. This 510(k) submission does not describe a clinical study with a test set. The substantial equivalence argument relies on comparing the CO-1000 Colposcope's specifications and design to a legally marketed predicate device, not on new clinical data demonstrating its performance against a specific test set.

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

• Not applicable / Not provided. No test set or ground truth establishment is described in this regulatory submission.

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

• Not applicable / Not provided. No test set or 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:

• No. This device is a colposcope, an optical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• No. This device is a physical optical instrument, not an algorithm. Standalone algorithm performance is not applicable.

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

• Not applicable / Not provided. No new clinical study requiring ground truth is described. The basis for clearance is substantial equivalence to a predicate device, which inherently means the predicate device's existing regulatory clearance and presumed safety and effectiveness serve as the "ground" for the new device's clearance.

8. The sample size for the training set:

• Not applicable / Not provided. No training set is mentioned as this device is a physical instrument, not a learned algorithm.

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

• Not applicable / Not provided. No training set or ground truth establishment is described.

In summary, the provided document is a 510(k) premarket notification for a Class II medical device, a colposcope. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device, not on presenting new clinical data from studies designed to meet specific performance acceptance criteria. Therefore, most of the detailed questions regarding study design, sample sizes, and ground truth establishment are not addressed in this type of submission.

Ask a specific question about this device

Soft tissue cutting & coagulation
Intraepithelial neoplasia
Condylomata acuminata
Misc. Iesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

The Gynex Electrodes are made of thin 0.18mm hard tungsten wire with a high melting temperature and excellent conductiveness of electric current. The electrodes are available in three different styles intended for use in two different types of electrosurgical procedure. The three styles are curved wire loop electrodes, square wire loop electrodes and ball-type electrodes. The two intended uses are excisional procedures (wire loop) and fulguration or coagulation procedures (ball electrode).

All electrode styles consist of an insulated conductive metallic shaft of varing length terminating in a bare metalic "ball" a "square wire loop" or a "curved wire loop". The wire loop electrodes vary in both width and depth of the loop. Electrode shaft diameter is constant at 2,5mm.

The provided document is a 510(k) premarket notification for Gynex Electrodes, a gynecologic electrocautery device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as typically found for novel AI/ML devices.

Therefore, the information required to answer your specific questions about acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document.

However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating equivalence in a 510(k) submission.

Here's a breakdown of the available information in the context of your questions, explaining why certain sections are not applicable:

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

• Not Applicable in this context. For a 510(k) submission of a traditional medical device like electrocautery electrodes, "acceptance criteria" and "reported device performance" are typically demonstrated through comparison to a legally marketed predicate device rather than through a novel performance study with specific metrics like sensitivity, specificity, etc., as would be expected for an AI/ML device. The "acceptance criteria" here is substantial equivalence to the predicate.

  The comparison table provided in the document (Section 11) is the closest equivalent, demonstrating how the Gynex Electrodes are substantially equivalent to the predicate device (Cooper Surgical Single-Use Wire Electrodes) across various features.

  Feature	Gynex Disposable Electrodes	Predicate Device (Cooper Surgical Single-Use Wire Electrodes)	Substantially Equivalent (SE)?
  Intended Use	Soft tissue cutting & coagulation, Intraepithelial neoplasia, Condylomata acuminata, Misc. lesions (polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon)	Same	YES
  Design	Tugnsten wire, Curved loop, Square loop, Brass ball electrode	Tugnsten wire, Curved loop, Square loop, Brass ball electrode	YES
  Sterile	Yes	Yes	YES
  Sizes	Various curved, square, and ball electrodes (listed)	Various curved, square, and ball electrodes (listed), plus additional sizes	YES
  Material	Tungsten wire, Stainless steel, Brass, Teflon	Tungsten wire, Stainless steel, Brass, Teflon	YES
  Origin	Europe	Europe	YES
  Manufacturer	Gynex Corporation	Cooper Surgical	YES
  Product Code	HGI	HGI	YES
  K - Number	Pending	K952483	YES

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. This document describes a medical device (electrodes) that falls under a 510(k) submission. It does not involve a diagnostic AI/ML algorithm that would typically require test sets or data provenance in the way your question implies. The "study" is primarily a physical and functional comparison to a predicate device.

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 above, there is no "test set" and thus no need for experts to establish ground truth as would be relevant for an AI/ML diagnostic algorithm.

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

• Not Applicable. No test set requiring expert adjudication is involved.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would be performed.

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

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

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

• Not Applicable. The "ground truth" equivalent in a 510(k) for a device like this is the established performance and safety profile of the legally marketed predicate device. The comparison demonstrates that the new device shares fundamental scientific technology, design, materials, and intended use with this predicate, implying equivalent safety and effectiveness.

8. The sample size for the training set

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

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

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

In summary: The provided document is a regulatory submission (510(k)) for a conventional medical device (electrocautery electrodes). The criteria you've asked about are specifically designed for evaluating Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under different regulatory and evidentiary standards than the device described in this 1999 filing. This document demonstrates substantial equivalence to a predicate device based on design, materials, intended use, and performance characteristics, rather than through a clinical performance study with AI-specific metrics.

Ask a specific question about this device

1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.

The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.

The provided text is a 510(k) premarket notification for the GYNEX Extended Reach Needle. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information on detailed acceptance criteria or a specific study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement. This type of regulatory submission for a simple medical device like a needle typically demonstrates safety and effectiveness through comparison to existing devices and compliance with relevant standards, rather than complex performance studies.

Therefore, many of the requested sections about study details, sample sizes, expert qualifications, and ground truth cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy. The "Comparison Table" in the document focuses on features for establishing substantial equivalence to the predicate device, not on quantitative performance against specific acceptance criteria.

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. The document does not describe a clinical performance study with a test set. The validation is based on comparison to an existing predicate device and adherence to manufacturing and materials standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no test set requiring expert ground truth is described.

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

Not applicable, as no test set 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 disposable needle, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a disposable needle, not an algorithm.

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

Not applicable, as no ground truth is established for performance evaluation of this device type in this submission. The "ground truth" for regulatory approval here is primarily based on the predicate device's established safety and efficacy, and compliance with manufacturing and materials standards.

8. The sample size for the training set

Not applicable, as there is no training set for an AI algorithm described.

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

Not applicable, as there is no training set for an AI algorithm described.

Summary of available information:

The provided document describes the GYNEX Extended Reach Needle as a Class II medical device intended for administering regional anesthetic blocks. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily the Potocky Needle (K910252) and preamendment devices.

Acceptance Criteria (Implicit via Substantial Equivalence and Standards):

While not explicitly presented as a "table of acceptance criteria" with numerical performance targets, the document establishes implicit acceptance criteria based on:

• Indications for Use: The Gynex needle must be suitable for administering paracervical-pudendal anesthetic, matching the predicate.
• Design: Leuer lock & threaded hub, comparable to predicate.
• Sterilization Method: Supplied sterile and non-pyrogenic via radiation, with a Sterility Assurance Level (SAL) of at least 10⁻⁶. This is a critical safety criterion.
• Dimensions/Sizes: 90mm with a 5mm 27 gauge tip, matching the Potocky predicate.
• Material: 302 Stainless Steel, matching the predicate.
• Manufacturing Standards: Compliance with voluntary standards such as ASTM, GYNEX Corporation Standard Operating Procedures (SOPs), vendor certification/qualification, Quality Systems Regulations (QSR), ISO materials standards, and ISO 9000 series quality regulations. This implies the device must meet specified mechanical properties, biocompatibility, and manufacturing quality.
• Packaging: Individually packaged and labeled, with instructions for inspection and handling to maintain sterility.

Reported Device Performance (Implicit/Feature Comparison):

The "Comparison Table" provides the "reported device performance" in terms of features relative to the predicate:

Note on Sterilization: The "NO & YES" for sterilization indicates that Gynex's radiation sterilization method differs from "Steam Autoclave - reusable" but is equivalent to "Potocky - Supplied sterile - disposable." The FDA found this acceptable for substantial equivalence.

This document serves as a regulatory submission demonstrating substantial equivalence for a medical device, and as such, does not typically include detailed clinical performance studies often associated with diagnostic or AI-driven devices.

Ask a specific question about this device

Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.

The Gynex Endospeculums are made of 300 series instrument grade stainless steel. There are two styles, plain handle and ratchet handle. Both have "gold" plate handles. Tip sizes are 3mm and 4mm for both handle types. Overall length of both types is 270mm (approx. 10 in.). The device is essentially identical to the Kogan endospeculum listed above. The blade tips are spring closed and pressing the handles together opens spreads the tips to compress the cervical wall and expand the cervical os or urethra for inspection.

Here's an analysis of the provided text regarding the Gynex Endospeculum, focusing on acceptance criteria and supporting studies:

It's important to note that the provided documents are a 510(k) premarket notification for a Class II medical device. For such devices, particularly those like manual surgical instruments, the "acceptance criteria" and "study" for performance are often centered around demonstrating substantial equivalence to a legally marketed predicate device and adherence to manufacturing and materials standards, rather than clinical trials with statistical endpoints for AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

For the Gynex Endospeculum, the acceptance criteria are not explicitly stated in numerical performance metrics as might be seen for software or diagnostic devices. Instead, they are implicit in the comparison to the predicate device and adherence to industry standards, ensuring the device is safe and effective for its intended use.

Explanation of "Acceptance Criteria":
In this context, the acceptance criteria are largely met by demonstrating that the Gynex Endospeculum is substantially equivalent to the predicate device ("Kogan Endospeculum, Gynecology, Obstetrics, V. Mueller, The Surgical Armamentarium, 1973"). This means it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The comparison table directly addresses this by showing similarities in design, materials, and sizes. Additionally, compliance with various quality and manufacturing standards serves as a form of acceptance criteria for ensuring safe and reliable production.

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

This is not applicable in the traditional sense of a "test set" for an AI algorithm or a clinical trial with patient data.

• Sample Size: Not applicable. The device is a manual surgical instrument. Its "performance" study is primarily a comparison of its physical and functional characteristics to a predicate device.
• Data Provenance: Not applicable for a "test set." The comparison is based on the characteristics of the predicate device (Kogan Endospeculum) which is a historical preamendment device. The design specifications and materials of the Gynex Endospeculum itself are the "data" being presented.

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

Not applicable. There is no concept of "ground truth" or expert review of a "test set" in the context of this 510(k) submission for a manual surgical instrument. The evaluation is focused on substantial equivalence to an existing device and adherence to manufacturing specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of AI performance or clinical study adjudication. The FDA's review process itself can be seen as an adjudication of substantial equivalence based on the provided information, but it's not a method applied to a dataset for device performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, imaging systems, or AI-powered tools where human interpretation is involved. The Gynex Endospeculum is a manual surgical instrument.

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

No, a standalone performance study was not done. This concept is relevant for AI algorithms. The Gynex Endospeculum is a physical, manual instrument and does not have an "algorithm-only" mode. Its performance is inherent in its physical properties, design, and manufacturing quality, and how it is used by a healthcare professional.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" (e.g., pathology, outcomes data) is typically used for diagnostic or AI-driven devices to validate accuracy. For a manual surgical instrument like the Gynex Endospeculum, the "truth" is established by its physical and functional characteristics matching the predicate device and meeting manufacturing standards, ensuring it performs its intended mechanical function safely and effectively.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for a manual surgical instrument. This concept is exclusive to machine learning and AI algorithms.

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

Not applicable. As there is no training set, there is no ground truth established for one.

Ask a specific question about this device

• Snare, grasp, hold & manipulate cervical and intravaginal tissue
• GYNEX Tenaculum Grasp/manipulate the cervix & soft tissue
• GYNEX Iris Hook Grasp/manipulate cervical tissue
• GYNEX Angle Hook Grasp/manipulate cervical tissue

The Gynex Iris and Angle Hooks & Emmett Tenaculums are made of 302 instrument grade stainless steel. All are used in similar way, each being a hook-like device used to snare, grasp, hold and manipulate the cervix, fundus and adjacent soft tissue. The important difference between the styles is that the radius of the hook tip is much smaller in the "Iris" and "angle" hook types. The devices are slender tapered metal rods, knurled on the proximal end and formed into a fine arc (hook) on the distal or working end. The devices are used to snare, hold and manipulate cervical and intravaginal tissue. Overall length of the hook/tenaculums is approximately 250mm for each type. The diameter of the hook tips is approximately 3mm for the Iris/angle styles and 8mm for the Emmett tenaculum style hook.

The Gynex Iris Hook, Gynex Angle Hook, and Gynex Emmett Tenaculum are manual surgical instruments, not AI/ML-driven devices. Therefore, the request regarding acceptance criteria and studies proving the device meets them in the context of AI/ML performance metrics (such as effect size of human readers with/without AI assistance, standalone algorithm performance, training set details, and ground truth establishment for AI models) is not applicable.

The provided document is a 510(k) premarket notification for traditional medical devices. The safety and effectiveness of these devices are established through substantial equivalence to legally marketed predicate devices, rather than through performance studies employing AI/ML specific methodologies.

Here's a breakdown of the available information relevant to traditional device clearance, framed to address the prompt where possible, noting the inapplicability of AI/ML-specific questions:

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

For these manual surgical instruments, "acceptance criteria" are typically met by demonstrating substantial equivalence to predicate devices, focusing on design, materials, indications for use, and sterilization. Performance is assessed qualitatively based on these similarities and the known safety of the predicate devices.

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 applicable. There was no "test set" in the context of an AI/ML study. The premarket notification relies on comparison to existing legally marketed devices (predicate devices) to establish substantial equivalence. No clinical performance data or specific test set for quantitative evaluation of device "performance" (beyond design and material specifications) is provided in this type of submission.

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. There was no ground truth establishment for a test set as this is not an AI/ML device. The "ground truth" equivalent for a traditional device 510(k) is the established safety and effectiveness of the predicate devices based on their long history of use and regulatory clearance.

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

This information is not applicable. There was no adjudication method used as there was no test set in the context of an AI/ML study.

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. This is not an AI-assisted device, so no MRMC study involving AI assistance would have been conducted or is relevant.

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

This information is not applicable. This device is a manual surgical instrument, not an algorithm.

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

This information is not applicable in the context of AI/ML ground truth. For a traditional 510(k) submission, the "ground truth" for demonstrating safety and effectiveness is primarily established through substantial equivalence to legally marketed predicate devices. This means the device performs similarly, has similar technological characteristics (materials, design, intended use), and therefore is considered as safe and effective as the predicate. The "truth" is that the predicate devices have proven safe and effective over time.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there was no training set.

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

This information is not applicable. This is not an AI/ML device, so there was no training set or ground truth establishment for it in that context.

Ask a specific question about this device