Search Results

The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.

The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.

The provided text is a 510(k) summary for a Sevoflurane Vaporizer Adaptor, which is a medical device for filling anesthetic vaporizers. This document does not contain information about acceptance criteria, device performance, a study design, or ground truth establishment typically associated with an AI/ML medical device. The device described is a physical adaptor, not a software algorithm.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details as it pertains to AI/ML device validation.

Instead, the document details the device's classification, intended use, and its substantial equivalence to a predicate device (Keyed Filler Bottle Adaptor K053564). The evidence provided for its safety and effectiveness relies on its similarity to the predicate device and compliance with ISO 5360:2006 for anesthetic vaporizers.

The relevant information from the provided text is:

Device Name: Sevoflurane Vaporizer Adaptor
Intended Use: To be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
Predicate Device: Keyed Filler Bottle Adaptor (K053564)
Key Statement for Equivalence: "The general design and materials of the Sevoflurane Vaporizer Adaptor is very similar to the predicate device. The only differences are the connection into the vaporizer and the model types... These differences do not make the Sevoflurane Vaporizer Adaptor any less safe or less effective than the predicate device."
Standard Compliance: "The device complies with the requirements of ISO 5360:2006."

To reiterate, the original request is designed for AI/ML device submissions, and this document does not contain any information relevant to those specific criteria.

Ask a specific question about this device

The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.

The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.

This document describes a 510(k) premarket notification for a medical device called the "Nasal Scavenging Circuit." This type of submission focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its independent safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA) application.

Therefore, the study conducted is not a traditional performance study comparing specific metrics against pre-defined acceptance criteria in the way an AI/ML device would be. Instead, the "study" is a set of non-clinical bench tests designed to show that the new device does not raise new issues of safety or effectiveness compared to its predicate.

Here's an analysis based on the provided text, addressing your specific questions to the best extent possible given the nature of a 510(k) submission for this type of device:

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

The device's technological characteristics, indications for use, and performance specifications are stated to be the same as the predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)), implying that it performs at least as safely and effectively as the predicate.

Adherence to pertinent sections of voluntary standards (NIOSH Publication No. 94-129, ISO 5356-1, ISO 5367, ANSI Z79.11-1982, CGA V-5) for design indicates meeting established safety and performance benchmarks for components and functionality. |
| Effectiveness: Device performs its intended function for removal of expired/excess gases. | "The indications for use, the technology, and the performance specifications are the same for the Nasal Scavenging Circuit and the predicate device." This statement is the core of the substantial equivalence claim, meaning its effectiveness is considered equivalent to the predicate.

The bench testing would have demonstrated functional performance, such as gas flow, scavenging efficiency, and connection integrity, consistent with the predicate device and relevant voluntary standards, though specific numerical performance metrics are not detailed in this summary. |
| Substantial Equivalence: Device does not raise new issues of safety or effectiveness. | The FDA’s letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices," based on the provided data from the manufacturer. |

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 in the context of human data. The "test set" consisted of physical devices subjected to non-clinical bench testing. The number of units tested is not specified in this summary.
• Data Provenance: The testing was "bench testing" meaning it was conducted in a laboratory setting. The location of MINRAD Inc. (Orchard Park, New York, USA) suggests the testing likely occurred in the USA or a facility associated with the company.
• Retrospective or Prospective: Not applicable for bench testing. It's a controlled experimental evaluation of the physical device's performance.

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

• Not applicable. This is a physical device being evaluated for substantial equivalence through non-clinical bench testing, not an AI/ML diagnostic device requiring expert interpretation of clinical data to establish ground truth. The "ground truth" (or performance standard) would be defined by the technical specifications of the predicate device and the relevant voluntary standards.

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

• Not applicable. Adjudication methods like "2+1" typically apply to expert reviews of clinical cases (e.g., in radiology studies) where there might be disagreement among reviewers on a diagnosis or finding. This submission involves bench testing of a physical device. Performance would be an objective measurement against a standard, not a subjective interpretation 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. An MRMC study is not relevant for this device. This is a physical gas scavenging circuit, not an AI/ML-driven diagnostic tool that assists human readers in interpreting data.

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

• Not applicable. This device is a physical product, not an algorithm or AI system.

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

• The "ground truth" for this 510(k) submission is effectively the performance and safety profile of the predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)) and adherence to relevant voluntary standards (e.g., NIOSH, ISO, ANSI, CGA V-5). The bench tests verify that the new device meets or is equivalent to these established engineering and safety standards.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. No training set exists for this type of device submission.

Ask a specific question about this device

The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.

The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.

The provided 510(k) summary for the Light Sabre™ Spinal Access Device does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria in the way typically discussed for AI/ML-based medical devices. This document describes a medical device (biopsy needle) and focuses on substantial equivalence to a predicate device, manufacturing standards, and biological safety.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of what can be derived from the document:

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

The document does not explicitly state "acceptance criteria" or provide performance metrics in quantitative terms for the device's function (e.g., biopsy success rate, accuracy of guidewire placement). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.

1. ASTM F1140-00
2. ANSI/AAMI/ISO 11137:1994
3. ANSI/AAMI/ISO 11737-1:1995
4. AAMI TIR 17:1997
5. AAMI TIR 27:2001
6. ANSI/AAMI/ISO TIR 15843:2000
7. ANSI/AAMI ST 72:2002
8. ASTM D-5276-98(2004)
9. ASTM F88-06
10. ISO 11607
11. ISO 9626:1991
12. ISO 594:1986
13. ISO 10993-1:2003
14. ISO 10993-5:1999
15. ISO 10993-10:2002 |
    | Sterility | Provided sterile for single use (Implies meeting sterility requirements, likely dictated by ANSI/AAMI/ISO 11137:1994 and related standards). |
    | Mechanical Features | Needle Length: 10 - 15cm
    Needle Gauge/Diameter: 8, 11, 13 Gauge
    Stainless Steel Material: Stainless Steel 304
    Stylet/Cannula Hub Material: Gamma Stable Polycarbonate
    Includes method to remove biopsy sample: Included in Packaging is Core Sampler made of Stainless Steel 304
    Able to connect Syringe for Aspiration or Injection: Luer Lock per ISO 594-2:1998 (E) on Luer Adapter Component |
    | Substantial Equivalence | Considered substantially equivalent to the Light Sabre™ Bone Biopsy Needle (K982735). |
    | Laser Targeting Integration | Integrates a collimating channel and light-dispersing element into the stylet assembly to work with the MINRAD SabreSource™ Targeting System (K022935). (Implies functional compatibility with the targeting system). |

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

This document does not describe a "test set" in the context of clinical performance data for an AI/ML device. The testing mentioned refers to material qualification and compliance with industry standards, not a clinical study on patient data.

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

Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment.

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 a medical device (biopsy 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.

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

Not applicable. The "ground truth" for this device would relate to its physical properties, sterility, and biocompatibility, which are assessed through laboratory tests against established standards, not clinical ground truth like pathology for a diagnostic device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML product.

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

Not applicable.

Ask a specific question about this device

The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The MR Fiber Optic Intubating Laryngoscope Handle, Standard

This document is a 510(k) summary for a medical device called the "MINRAD INC.'s MR Fiber Optic Intubating Laryngoscope Handle, Standard." It outlines the device's information, intended use, and substantial equivalence to predicate devices, leading to its clearance by the FDA in 2006.

1. Table of acceptance criteria and the reported device performance

This document does not list specific acceptance criteria related to quantifiable performance metrics (e.g., accuracy, precision, sensitivity, specificity) or any reported device performance data in that context. The clearance is based on substantial equivalence, implying the device performs similarly to predicate devices without needing a new clinical performance study for this specific 510(k). The primary "acceptance criteria" for this submission are related to its similarity in technological characteristics and intended use to existing, legally marketed devices.

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 510(k) summary does not describe a clinical study with a test set in the traditional sense of evaluating performance metrics like sensitivity or specificity. The submission is based on demonstrating substantial equivalence to predicate devices, not on original clinical performance data for the new 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 noted above, there is no mention of a test set with ground truth established by experts.

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

Not applicable. No test set 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

Not applicable. This device is a physical medical instrument (a laryngoscope handle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No ground truth is described as having been established for this submission.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set.

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

Not applicable. No training set or ground truth for it is relevant to this device submission.

Ask a specific question about this device

The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

MR Fiber Optic Intubating Laryngoscope Handle, Short

The provided text is a 510(k) summary for the "MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short." This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance is not available in the provided text.

The document primarily states:

• The device's intended use: to facilitate and aid in tracheal intubation in an MRI or interventional MR environment (not exceeding 3.0 Tesla).
• Its classification: Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW).
• Predicate devices it is substantially equivalent to: MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle (K041852), Welch Allyn Laryngoscope, and Sun Med Laryngoscope.
• The assertion that it "raises no new issues of safety or effectiveness" due to its similar technological characteristics to predicate devices.

Ask a specific question about this device

The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle."

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the manner of a performance study for an AI/CADe device.

This document is a regulatory clearance for a traditional medical device (a laryngoscope handle) based on substantial equivalence to a predicate device, not on specific performance metrics from a clinical or technical study outlined in your request. The FDA's determination of substantial equivalence (510(k)) means they believe the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions. The document does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes for test sets, data provenance, or ground truth.
• Details about expert reviews, adjudication methods, or MRMC studies.
• Any mention of standalone algorithm performance.
• Information about training sets or their ground truth establishment.

The clearance is based on the device conforming to general controls and being equivalent to existing devices, specifically for use in an MRI environment up to 1.5 Tesla. The "indications for use" (Attachment 8, Page 2) simply state its purpose: "to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field." This is a statement of intended use, not a performance metric or acceptance criteria.

Ask a specific question about this device

The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.
The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.

The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient.

The provided text describes a 510(k) premarket notification for the SabreSource™ Drape. This is a medical device accessory and the submission focuses on its substantial equivalence to predicate devices, rather than establishing its performance through a study with acceptance criteria in the typical sense of a diagnostic or therapeutic device.

Therefore, the requested information for acceptance criteria and a study proving performance cannot be fully provided in the format requested, as that type of study was not conducted or required for this device. The information provided outlines the technological characteristics and intended use that form the basis for its substantial equivalence, which is the primary "proof" for this type of device.

Here's how to address the request based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device revolves around its ability to function as a sterile barrier and allow laser transmission, thereby being substantially equivalent to existing devices.

Study Details (Not applicable for this type of submission)

The provided document describes a 510(k) submission for a medical device accessory (a drape). For such devices, the primary "proof" is demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting a controlled clinical study with specific acceptance criteria, sample sizes, and ground truth in the way one would for a diagnostic algorithm or a novel therapeutic device.

Therefore, the following information is not available or applicable from the provided text:

• Sample size used for the test set and the data provenance: No test set or clinical study was mentioned or required for this 510(k) submission.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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, as this is not an AI diagnostic device or one involving human reader performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context is established by the functional characteristics of the drape (sterility, optical clarity) and its equivalence to predicates.
• The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
• How the ground truth for the training set was established: Not applicable.

In summary: The K041846 submission for the SabreSource™ Drape is a 510(k) premarket notification that relies on demonstrating substantial equivalence to predicate devices. The "proof" is in showing that its technological characteristics and intended use are similar to already approved drapes, and any differences raise "no new issues of safety or effectiveness." This type of submission does not typically involve the detailed performance studies, ground truth establishment, and expert reviews that would be required for a novel diagnostic or AI-powered device.

Ask a specific question about this device

A single use disposable spinal needle/cannula intended for the injection of fluids into or retraction of fluids from the body. A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.

The Light Saber™ Spinal Needle consists of a needle and a collimator to which a stylet is attached. The stylet is enclosed in a cannula/hub assembly with a matching tip. The female Luer of the cannula hub, for the attachment to the syringe, is designed to comply with ISO-594 for "Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Other Medical Equipment." The Light Saber™ Spinal Needles are provided in gauges of 18, 20, 22, 23, and 25. The Light Saber™ Spinal Needle will be provided in lengths of 3.75, 6.25, 8.75, 15 and 20 cm. The tip design for these needles will provide either a Quincke, Short Bevel or Chiba point. Depth markings are standard on the cannula.

The provided text describes a 510(k) premarket notification for the MINRAD, Inc. LIGHT SABER™ SPINAL NEEDLE. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

• Device Identification: Name, sponsor, common/classification names.
• Predicate Devices: Lists similar devices.
• Intended Use: Specifies the purpose of the device (injection/aspiration of fluids, use with MINRAD Inc.'s Dual Radiation Targeting System™ for improved accuracy).
• Technological Characteristics: Describes the physical attributes of the needle (needle/collimator, stylet, cannula/hub assembly, Luer compliant with ISO-594, various gauges, lengths, and tip designs).
• Substantial Equivalence: Asserts the device's equivalence to predicate devices, stating minor differences in general indications for use and size/needle tip configurations raise no new safety/effectiveness issues.
• FDA Correspondence: Official FDA letter regarding the substantial equivalence determination, outlining regulatory compliance information.
• Indications for Use Form: A formal declaration of the device's intended use and indications.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as this data is absent from the provided text.

To answer your request, the input text would need to include details of specific performance metrics, benchmarks, and the results of any tests or studies conducted to demonstrate the device meets those metrics.

Ask a specific question about this device

Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.

The Light Saber Introducer Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals.

The provided text, K013040 for the MINRAD, INC. Light Saber™ Introducer Needle, is a 510(k) summary and FDA clearance letter. It does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving a device meets those criteria, particularly for a device that relies on complex performance metrics like an AI/ML algorithm.

The Light Saber™ Introducer Needle is a physical medical device designed to gain percutaneous access for surgical procedures, and specifically to be used with a Dual Radiation Targeting System (DRTS) to improve needle placement accuracy.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this 510(k) submission for this type of device. The FDA clearance for this device, as indicated in the provided documents, is based on substantial equivalence to predicate devices, not on a clinical study demonstrating performance against specific numerical acceptance criteria for an AI/ML algorithm.

However, I can still extract relevant information about the device and its clearance process:

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

• Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds. For substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to predicate devices.
• Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) akin to those for AI/ML algorithms are reported. The document states:
  • "The Light Saber Introducer Needle is identical to a combination of its predicate devices."
  • "These minor differences raise no new issues of safety or effectiveness."
  • "Thus, the MINRAD, INC. Light Saber™ Introducer Needle is substantially equivalent to its 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)

• Not applicable. This submission does not describe a clinical test set of real-world cases with associated data for an AI/ML algorithm. The equivalence is based on design comparison and intended use, not statistical performance on a dataset.

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. Ground truth establishment by experts for a test set is not part of a substantial equivalence submission for a physical introducer needle.

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

• Not applicable. No test set or adjudication process as described for AI/ML algorithms is mentioned.

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. No MRMC study was conducted or reported for this device. The device itself is an introducer 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. The device is a physical introducer needle; there is no standalone algorithm performance to evaluate.

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

• Not applicable. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this submission. The "ground truth" for substantial equivalence is the existing regulatory classification and safety/effectiveness profile of the predicate devices.

8. The sample size for the training set

• Not applicable. There is no AI/ML algorithm involved, so no training set.

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

• Not applicable. No training set or ground truth establishment process as described for AI/ML algorithms is mentioned.

In summary: The provided 510(k) summary for the MINRAD, INC. Light Saber™ Introducer Needle focuses on demonstrating substantial equivalence to existing predicate devices based on design, intended use, and technological characteristics. It does not involve performance studies or data analysis in the way modern AI/ML medical devices require, as it is a physical surgical tool.

Ask a specific question about this device

"Disposable needle for obtaining biopsies from Bone and Bone Marrow."

Not Found

I am sorry, but the provided text does not contain the information requested. The document is an FDA letter regarding the 510(k) clearance for a bone biopsy needle and includes sections on "Indications for Use." However, it does not detail any acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed submission summary. Therefore, I cannot generate the requested table or answer the specific questions about the study.

Ask a specific question about this device