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INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.

Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) submission for Instrumed Vessel Dilators. This is a traditional medical device, not an AI/ML powered device, therefore the typical AI/ML-related study criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context. The acceptance criteria and supporting "studies" are focused on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, material analysis, and existing market data, rather than clinical trials with human subjects or AI model performance metrics.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a 510(k) for a physical medical device:

Acceptance Criteria and Device Performance for Instrumed Vessel Dilators

The "acceptance criteria" for the Instrumed Vessel Dilators are primarily based on demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device meets specific performance characteristics and safety requirements, similar to the predicate. The "reported device performance" reflects how the Instrumed Dilators met these equivalence criteria through various non-clinical tests and evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

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

Given this is a physical device and not an AI/ML model, the concept of a "test set" for performance evaluation is different.

• Sample Size: The document does not specify exact sample sizes for each type of bench test (e.g., how many dilators were tested for tip retention, corrosion, etc.). It generally refers to "the proposed device" or "the new devices" in plural, implying a representative number were subjected to the specified tests.
• Data Provenance:
  • Bench Testing: Performed on the proposed Instrumed Vessel Dilators. The country of origin for this testing is not explicitly stated but assumed to be under the applicant's (INSTRUMED INTERNATIONAL, INC. in Schaumburg, IL) oversight. This is prospective testing performed specifically for the 510(k) submission.
  • Clinical Evaluation: Based on "literature research" and "market surveillance information." This includes "database evaluation," "scientific literature," and "data from market experience of the same or similar devices."
  • Market Experience: Data from Instrumed International's own sales (hundreds of dilators over 5 years to non-US markets) with "no reported customer complaint or potentially reportable event." This data is retrospective from global markets (markets other than US).

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

This question is not applicable to this type of device. The "ground truth" for a physical device like a dilator is established through engineering standards, mechanical tests, material specifications, and clinical consensus on safe and effective surgical practice. There is no concept of "experts establishing ground truth for a test set" in the way it applies to diagnostic AI systems. Expert surgeons would use these devices, but their role in a 510(k) for this product is primarily related to the general acceptance and understanding of dilator function and safety, not as ground truth adjudicators for a specific performance evaluation dataset.

4. Adjudication Method (for the test set)

This question is not applicable. The "test set" here refers to the physical devices undergoing bench testing. The outcomes of these tests (e.g., measured diameter, material composition, breakage force) are objective measurements against defined specifications or standards, not subjective interpretations requiring 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 conducted for diagnostic devices (especially imaging-based ones) to assess how human reader performance changes with or without an AI aid. Instrumed Vessel Dilators are surgical instruments, not diagnostic tools, so an MRMC study is not relevant.

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

No, a standalone study was not done. This concept applies specifically to AI algorithms. The Instrumed Vessel Dilators are physical devices that are inherently used "with human-in-the-loop" (i.e., by a surgeon).

7. The Type of Ground Truth Used

The "ground truth" for the Instrumed Vessel Dilators is based on a combination of:

• Engineering Specifications and Standards: For dimensional accuracy, material properties (ASTM F 899-07), mechanical strength, and corrosion resistance.
• Predicate Device Performance and Safety Profile: The established safety and effectiveness of the legally marketed predicate devices (KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, K030788 AND DEBAKEY VESSEL DILATORS) serve as a de facto "ground truth" for what constitutes acceptable device performance and safety for this class of device.
• Clinical Literature and Market Surveillance: General medical understanding of appropriate indications for use and safe practices for vessel dilation.
• Biocompatibility Standards: To ensure the material is non-cytotoxic and safe for contact with human tissue.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model involved; therefore, no "training set."

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

This question is not applicable. There is no AI model involved; therefore, no "training set" ground truth to establish.

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INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage - · suspicion of immediate or potential fetal compromise - · shortening of the second stage for maternal benefit

Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery. Forceps have 4 major components, as follows: - Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve). - Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing. - Lock: The lock is the articulation between the shanks. Many different types have been designed. . - Handles: The handles are where the operator holds the device and applies traction to the fetal . head. The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure. Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) submission for Instrumed Obstetrical Forceps. It details the device's description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the content provided, the acceptance criteria and the study proving the device meets them are articulated in terms of equivalence to predicate devices, rather than specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a test set or data provenance in the context of clinical studies with human participants. The evaluation relies on non-clinical and bench testing to demonstrate similarity to predicate devices. Therefore, traditional "sample size" for a clinical test set is not applicable here.

• Sample Size for Test Set: Not applicable as no human clinical test set is described. The evaluation is primarily based on non-clinical and bench testing of the device itself and comparison to predicate devices.
• Data Provenance: Not explicitly stated as the evaluation focuses on the physical device and its properties, materials, and design in comparison to existing devices.

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

This information is not provided in the document. Given that the submission is for substantial equivalence based on non-clinical and bench testing and comparison to predicate devices, there's no mention of a ground truth established by medical experts for a test set of patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document. As no human clinical test set requiring expert ground truth or adjudication is described, this section is not applicable.

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 conducted or described in this submission. The device is a surgical instrument (forceps), and its evaluation is based on material properties, design, and functional similarity to already marketed predicate devices, not on the interpretation of medical images by multiple readers.

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

This question is not applicable as the device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator (the surgeon).

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly established by the known safety and effectiveness of the predicate devices and the standards for material properties (e.g., ASTM F 899-09 for stainless steel). The claim is that the Instrumed Obstetrical Forceps functions equivalently to these well-established devices and uses appropriate materials, thus achieving safety and effectiveness.

• Implicit Ground Truth: Safety and effectiveness of legally marketed predicate devices and compliance with material standards.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set."

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

This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set" or its associated ground truth establishment.

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INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.

Instrumed gynaecological forceps are heavy forceps which have special designed jaws to hold securely without slipping during vaginal and abdominal hysterectorny procedures, yet do not lacerate the tissue to which it has been applied to even when it is necessary to exert traction.
The Instrumed gynaecological forceps are reusable surgical instruments.
To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:

• length and bending of the forceps and jaws .
• ring handles with a ratchet closure to adjust the amount of tension applied.
• jaw design, option of longitudinal grooves, teeth or cross serrations .
• the choice of jaw style depends on the surgeon's preference .
  The surgeon chooses the gynaecological forceps based on the anatomy of the site and the designs desired are based on the type of the surgical procedure.
  Instrumed gynaecological forceps are made of the ASTM F 899-07 standardized Stainless Steel.
  The instruments are offered in non-sterile condition.

This document is a 510(k) summary for a medical device called "Instrumed Forceps Gynaecological." It's a regulatory filing to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no acceptance criteria or dedicated study described that proves the device meets specific performance criteria in the way typically associated with advanced AI/Software as a Medical Device (SaMD) clearances or certain diagnostic devices.

Here's an analysis based on your requested information:

1. Table of acceptance criteria and the reported device performance

Explanation: This 510(k) is for a set of manual surgical instruments (gynecological forceps). For such devices, the "acceptance criteria" and "performance" are typically assessed through comparisons to predicate devices in areas like material composition, manufacturing processes, intended use, and general safety/effectiveness, rather than quantitative performance metrics like sensitivity/specificity for diagnostic AI. The document asserts comparability and successful completion of standard evaluations for surgical instruments like biocompatibility and sterilization.

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

• Sample Size: Not applicable. This document does not describe a clinical study with a "test set" of patient data in the context of device performance in a diagnostic or AI-driven sense. The "testing" mentioned is non-clinical and bench testing of the instruments themselves.
• Data Provenance: Not applicable.

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. There is no mention of a "test set" requiring ground truth established by experts. The device is a manual surgical instrument.

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 device is not an AI/SaMD product.

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

• Not applicable. This device is not an algorithm or SaMD.

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

• Not applicable in the context of diagnostic performance. For manual surgical instruments, "ground truth" relates to their physical properties, material conformity (e.g., ASTM F 899-07 standardized Stainless Steel), sterility, and ability to perform their mechanical function compared to similar devices. The document implies compliance with these standards through "non-clinical and bench testing."

8. The sample size for the training set

• Not applicable. This device is not an AI/Machine Learning model.

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

• Not applicable.

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INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.

The Instrumed Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:

• . Some have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
• Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross – action mechanism to apply tension to the vessel for occlusion.
• The choice of jaw style depends on the surgeon's preference, based on the type and delicacy of ↓ the vessel to be occluded.
  The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
  Instrumed vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy,
  The instruments are offered in non-sterile condition.

This is a 510(k) premarket notification for the Instrumed Vascular Clamp, a reusable surgical instrument. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria or quantitative performance metrics are provided in the document for the Instrumed Vascular Clamps. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The reported device performance is qualitative, asserting that the new device is "completely comparable" to the predicate devices.

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

The document states that "non-clinical and bench testing" was conducted. However, it does not specify the sample size used for the test set.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a surgical instrument, the non-clinical and bench testing would generally be prospective testing conducted by the manufacturer.

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

This information is not provided in the document. For a physical device like a vascular clamp, "ground truth" would likely be established through standardized engineering tests and material analyses, not through expert consensus in the typical sense of image-based or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation appears to be based on direct testing and comparison to predicate devices' specifications, not on expert adjudication of ambiguous cases.

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 conducted for diagnostic devices where human interpretation is a key component, not for surgical instruments like vascular clamps.

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

This question is not applicable as the device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the performance of the vascular clamps would be based on:

• Engineering Specifications/Standards: Performance criteria related to material strength, clamping force, corrosion resistance, sterilization effectiveness, and biocompatibility, as defined by relevant industry standards (e.g., ASTM F 899-07 for Stainless Steel).
• Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not provided and is generally not relevant for this type of device submission. There is no "training set" in the context of a physical surgical instrument; it's not a machine learning algorithm.

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

This question is not applicable as there is no "training set" for this device.

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The intended use of Instrumed Rongeurs is to access, cut and bite soft tissue and bone during surgery involving the spinal column.

A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue.

IVD (Intervertebral Disc) Rongeurs are used on cartilage that separates adjacent vertebrae of the spine A rongeur can be used to open a window in a bone. It is used in neurosurgery to expose areas for operation or to reduce pressure by segregating exposed areas.

To ensure the multi-purpose use of this devices, many different models are available.

Common names used for this kind of Rongeurs are: Kerrison, Sella Punch, IVD (Decker, MIS, Spence, Peapod, Selverstone, Williams, Cushing, Love-Gruenwald, Spurling, Cloward, Sypert, Ferris-Smith, Wilde, Hoen, Oldberg, Jackson, Schlesinger)

A manual rongeur is a manually operated instrument used for cutting or biting surgery involving the skull or spinal column.

All Rongeurs are offered in a non-sterile condition.

The provided 510(k) summary for the Instrumed Rongeur does not contain the kind of detailed performance study and acceptance criteria information typically found in submissions for diagnostic AI devices, or even for many other types of medical devices that require quantitative performance data. This Rongeur is a manual surgical instrument, and its 510(k) submission primarily relies on a comparison to predicate devices, rather than robust quantitative performance metrics.

Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the 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)

• Not applicable / Not provided. The submission focuses on design analysis and comparison to predicate devices, not on a clinical "test set" in the context of diagnostic performance. There is no mention of a specific sample size of patients or a test set of data.

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 "ground truth" establishment by experts, in the sense of reviewing diagnostic images or clinical outcomes, is mentioned. The assessment of substantial equivalence appears to be an internal engineering and regulatory comparison.

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

• Not applicable / Not provided. No adjudication method is mentioned as there is no "test set" and associated expert review.

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 / Not done. This refers to studies for diagnostic AI devices. The Instrumed Rongeur is a manual surgical instrument and does not involve AI assistance or human readers in an MRMC study context.

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

• Not applicable / Not done. This refers to performance of a standalone AI algorithm. The device is a manual surgical tool.

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

• Not applicable / Not explicitly defined in terms of quantitative data. The "ground truth" for this type of submission is implicitly the established safety, effectiveness, and functional characteristics of the predicate devices based on their historical use and regulatory clearances. The new device is evaluated against these benchmarks.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable / Not provided. As there is no training set, this information is not relevant.

Summary of the Study / Basis for Clearance:

The "study" in this context is a design analysis and comparison of the Instrumed Rongeur against several legally marketed predicate rongeurs (K062711, K023868, K943635, and others). The manufacturer claims that the new device is substantially equivalent to these predicates.

The core of the argument for safety and effectiveness is that:

• The Instrumed Rongeur shares similar technical characteristics, design, indications for use, target population, performance expectations, biocompatibility, sterilization methods, mechanical safety characteristics, and available sizes and configurations with the predicate devices.
• The materials used are "well researched" and do not introduce new safety or effectiveness concerns.

Essentially, the clearance is based on the premise that because the new rongeur is sufficiently similar to devices already proven safe and effective for their intended use, it too can be considered safe and effective without requiring extensive new clinical performance data.

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INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, endoscopes and surgical instruments can be manipulated.

Instrumed Retractors (frame, arm, blades, tubes) provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement and positioning of the retractor posterior, anterior cervical and down to the laminalspine, with its attachment to a rigid frame or a flexible arm to provide a self locking method of access to the spinal site through which a endoscope and/or surgical instruments can be manipulated.

The provided document, K071771, is a 510(k) Pre-Market Notification Summary for the Instrumed Retractors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with acceptance criteria for device performance as would be expected for novel devices or higher-risk classifications.

Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication methods, and ground truth establishment is not present in this document because it is not typically required nor performed for a 510(k) submission of this nature.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no quantitative table of acceptance criteria or specific device performance reported in a measurable way (e.g., accuracy, sensitivity, specificity, mechanical durability numbers). The 510(k) submission for the Instrumed Retractors relies on demonstrating "substantial equivalence" to predicate devices, meaning it performs similarly and is as safe and effective.

The summary states:
"The presented data that was conducted on the Instrumed Retractors shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness."

This is a general statement of equivalency rather than specific, quantified performance against predefined acceptance criteria. Testing likely involved mechanical testing to ensure the device performs its intended function (e.g., maintaining position, retracting tissue) and material safety, but specific performance metrics are not listed.

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

• Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical "test set" in the context of a prospective study to evaluate new performance metrics. The claim is based on comparison to predicate devices and the fact that "All models that are covered by this 510(k) premarket notification have been on the market (international) for many years with no device failures." This implies real-world usage data, but a formal "test set" with a defined sample size as for a new performance study is not discussed.
• Data Provenance: The statement "have been on the market (international) for many years with no device failures" suggests the data provenance is historical, real-world usage from established markets, likely outside the US initially, given the international mention. This is retrospective observational data rather than a controlled prospective study.

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

Not applicable. No ground truth establishment by experts for a specific test set is described, as the submission relies on substantial equivalence and historical performance rather than a new clinical performance study requiring such an assessment.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

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

No. This type of study is not mentioned or implied. The device is a surgical retractor, not an imaging or diagnostic device that would typically involve a multi-reader study. The comparison is between the new device and predicate devices based on design, materials, and intended use, not human reader performance with or without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:

Not applicable. The device is a physical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable in the conventional sense of establishing a medical diagnosis. The "ground truth" here is implied to be the proven safety and effectiveness of the predicate devices over time, coupled with the assertion that the new device shares similar characteristics and has also performed reliably ("no device failures") in prior (international) market use. The safety of the materials is also a "ground truth" established through prior research and use.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set, as this is not an AI/algorithm-driven device.

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

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

In summary, for K071771, the "study" that proves the device meets (implied) acceptance criteria is a demonstration of substantial equivalence to predicate devices and the historical safety record of the Instrumed Retractors in international markets. This is a common pathway for Class II medical devices that are similar to existing ones, and it does not involve the detailed clinical trial and performance metric reporting often associated with novel medical technologies or higher-risk devices.

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Instrumed Laparoscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures.

Instrumed Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures

This document describes a 510(k) premarket notification for Instrumed Laparoscopes and Accessories. The submission claims substantial equivalence to a predicate device, the Gimmi Laparoscope (K012660). Therefore, the study details you are asking for, which typically involve demonstrating performance against defined acceptance criteria, are not directly presented as they would be for a novel device requiring such proof.

Instead, the submission relies on demonstrating technical similarity and that the Instrumed instruments are "absolutely safe and effective for its intended use and do not raise any questions regarding safety and effectiveness" based on performance data conducted on the Instrumed instruments. However, the specific details or content of this "performance data" are not provided in this summary.

Given the nature of a 510(k) submission seeking substantial equivalence to a predicate device, a formal study demonstrating a device meets a specific set of acceptance criteria with detailed statistical analysis and power calculations, as you might expect for a new technology, is generally not required in the same way. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the specific questions about sample size, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable or not explicitly provided in this summary document focused on substantial equivalence.

Here's an attempt to address your questions based on the provided text, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "presented data that was conducted on the Instrumed instruments."

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

• Not applicable/Not specified. A formal expert-driven ground truth establishment for a test set is not described as part of this substantial equivalence claim.

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

• Not applicable/Not specified.

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-assisted device, and no MRMC study is mentioned.

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

• Not applicable. This is a medical device (laparoscopes and accessories), not an algorithm or AI.

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

• Not explicitly stated. The "performance data" would likely have involved engineering tests, material testing, and potentially some form of clinical observation or simulated use, but the nature of the "ground truth" (e.g., benchmark values, successful function, lack of adverse events) is not detailed.

8. The sample size for the training set

• Not applicable/Not specified. This is not a machine learning or AI device that would typically have a "training set."

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

• Not applicable/Not specified as there is no "training set" described.

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