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The SabreLine™ and SabreGuard™ Laser Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Coloplast surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector.

The Coloplast SabreGuard™ and SabreLine™ Laser Fibers are fiber optic laser delivery devices that transmit laser energy to soft and hard tissue in contact and non-contact mode during surgical laser procedures. The devices are 3.0 meters in length and are terminated with a SMA-905 connector on the proximal end. A laser fiber is made of silica inner core, with a primary and secondary cladding surrounded by a polymeric jacket. The laser fibers are compatible with laser systems operating in wavelengths between 500 nm - 2200 nm. The laser delivery devices are intended for use with any cleared surgical laser with a SMA-905 connector. Coloplast reference SUNXXX are equipped with a round tip, Coloplast reference SUEXXX are equipped with a radius tip; Coloplast reference SUDXXXX and RUSXXXX are equipped with a straight tip. Single use laser fibers are delivered sterile in a retail box of 3, with an instruction for use in paper version. Reusable laser fibers are delivered sterile in a retail box of 1, with an instruction for use in paper version.

This document describes the Coloplast SabreLine and SabreGuard Laser Fibers (K182831).

A table of acceptance criteria and the reported device performance is not explicitly provided in the given text. However, the document outlines the types of performance data (mechanical testing, biocompatibility, sterilization, and packaging) that were conducted to support the substantial equivalence determination. The conclusion states that the device is substantially equivalent to the predicate based on "non-clinical data provided, similar intended use, materials, design and construction, biocompatibility, and technological characteristics," implying that the performance data met unstated internal acceptance criteria for these characteristics.

Based on the provided information, I can extrapolate the types of tests done and their implied acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions "a comprehensive regimen of testing" and "mechanical testing was completed as follows to verify the product design performance," implying that sufficient samples were tested to achieve statistical significance or meet regulatory requirements for each test.
• Data Provenance: The document explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means all data is non-clinical performance data, likely derived from in vitro and benchtop testing. The origin of this data is Coloplast's internal testing.

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 as the device is a laser fiber and its substantial equivalence was determined through non-clinical performance data, not through expert-reviewed clinical data or diagnostic accuracy studies. There was no "ground truth" to be established by experts in a diagnostic context for these tests.

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

• This information is not applicable for the same reasons above. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which were not part of this 510(k) submission.

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

• This information is not applicable. The device is a medical instrument (laser fiber), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

• This information is not applicable as the device is a medical instrument, not an algorithm or AI system.

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

• For the non-clinical performance tests, the "ground truth" was established by engineering specifications, material standards, and validated test methods. For example, for tip diameter, the ground truth would be the design specification for the tip diameter. For biocompatibility, the ground truth would be the criteria for non-toxicity, non-sensitization, etc., as defined by ISO 10993-1.

8. The sample size for the training set:

• This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• This information is not applicable for the same reasons above.

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The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six mon-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The designed for use with supplemental fixation and with autogenous and/or

allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. Choice Spine Interbody Fusion System (Harrier™):

The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Choice Spine Vertebral Body Replacement System (Hawkeye™):

The Choice Spine Vertebral Body Replacement (VBR) System is in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Vertebral Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion

The implant components are available in two material varieties, Materials: polyetheretherketone (PEEK-OPTIMA® LT1, Invibio® or Zeniva® PEEK, Solvay) as described by ASTM F2026 with integral radiopaque markers manufactured from tantalum as described by ASTM F560. The second implant variety is Titanium alloy (Ti-6Al-4V ELI) which conforms to ASTM F136. All chosen materials are commonly used in medical devices. The implants will be provided non-sterile, but will be steam sterilized before use.

This document is a 510(k) premarket notification from the FDA for several spinal interbody fusion devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on regulatory clearance, device descriptions, and comparison to predicate devices, but lacks the specific details requested in your prompt regarding performance studies.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that because the designs of the implants are similar between material types (PEEK or Titanium Alloy) and have been previously cleared, and the Titanium implants are expected to be stronger, "no new non-clinical testing is needed." This explicitly indicates that no new performance studies (which would involve acceptance criteria and test sets) were conducted for this specific submission.

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Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):

The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Choice Spine VEO™ Lateral Access & Interbody Fusion System:

The Choice Spine VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.

Choice Spine Interbody Fusion System:

The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

This submission includes three lumbar implant families. The device description for each family is listed below.

Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):

The Choice Spine Lumbar Spacer System consists of interbody fusion devices (specifically, SABRE, SHARK™, HORNET™ & HARPOON™ Lumbar Spacers) comprised of polyetheretherketone (PEEK - Optima®) with tantalum markers (ASTM F2026 and ASTM F560) or Ti-6AI-4V ELI (ASTM F136). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped anterior surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. These implants are delivered via a posterior or transforaminal approach.

Choice Spine VEO™ Lateral Access & Interbody Fusion System:

The Choice Spine VEO™ Lateral Access & Interbody Fusion System is a multicomponent system including instrumentation made of stainless steel. Aluminum. and Radel R and implants made of tantalum (ASTM F560) and PEEK Optima® (ASTM F2026) or Ti-6Al-4V ELI (ASTM F136). The implants are delivered via lateral approach.

Choice Spine Interbody Fusion System:

The Choice Spine Interbody Fusion System is a family of implants intended to aid in spinal fixation of the lumbar spine. This system includes implants made of Zeniva ZA-500 PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136), which are delivered via anterior or anterolateral approach.

The provided document is a 510(k) summary for several intervertebral body fusion devices. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for a device's performance.

The document primarily focuses on:

• Indications for Use: What conditions the devices are intended to treat.
• Device Description: The materials and general design of the implants.
• Comparison to Predicate Devices: An assertion that the new devices are substantially equivalent to previously cleared devices.
• Non-Clinical Testing: A statement that "no new non-clinical testing is needed" due to the design being the same if manufactured from Titanium instead of PEEK.

In the context of a 510(k) submission for these types of devices, the "acceptance criteria" are typically related to demonstrating substantial equivalence through a comparison of technological characteristics and intended use, often supported by non-clinical performance data (e.g., mechanical testing to ASTM standards), rather than clinical performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, I cannot extract the requested information from this document. The document specifically states: "no new non-clinical testing is needed," implying that the performance was considered sufficiently similar to the predicate devices based on design and material changes, and thus no new study specifically proving acceptance criteria for device performance was required or submitted as part of this 510(k).

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When used as an intervertebral body fusion device, Choice Spine lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L 2 - S 1 , in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation systems such as (ORIA Claris, ORIA Spinal Clip System, etc.).

When used as a vertebral body replacement device, Choice Spine lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5 , for the replacement of a collapsed or unstable vertebral body resulting from a turnor or traumatic injury. The device system is designed for use with supplemental fixation (ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft bone to facilitate fusion.

The 9mm width spacer system (SABRE, SHARK, HORNET, HARPOON) has a rectangular shape, a hollow center for placement of autograft bone, and a smooth anterior surface (nose). It is available in a variety of heights, length, and lordosis combinations with and without medial-lateral curvature to accommodate many different anatomic requirements.

The provided text describes the Choice Spine Lumbar Spacer System, which is a medical device. The information details the device's indications for use, materials, and a declaration of substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, many of the requested categories are not applicable to the provided document. The document describes a traditional medical device (spinal spacer), not an AI or algorithm-based device.

Here's a breakdown based on the information provided, highlighting what is and isn't available:

Acceptance Criteria and Study for Choice Spine Lumbar Spacer System

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

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

• Not Applicable. The document describes mechanical performance testing of the physical device (spinal spacer) rather than a test set for an AI/algorithm. The "test set" in this context would refer to the physical spacers subjected to the performance tests. The specific number of devices tested is not provided, but the testing was conducted by an "independent laboratory."

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, and "ground truth" for mechanical performance is established by standardized testing methods, not expert consensus interpretation of data.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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 implant; it does not involve human readers or AI assistance.

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

• Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• For the performance testing, the ground truth is established by physical measurement against the requirements of the ASTM standards (ASTM F2077-11 and ASTM F2267-04) and comparison to the performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/algorithm requiring a training set.

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

• Not Applicable. See point 8.

Summary of the Study:

The "study" described in the provided text is a series of mechanical performance tests conducted on the Choice Spine Lumbar Spacer System. These tests were performed by an independent laboratory according to established ASTM standards (ASTM F2077-11 and ASTM F2267-04). The tests covered static axial compression bending, static torsion, dynamic axial compression bending, and dynamic torsion.

The overall conclusion of these tests was that the device's performance was "substantially equivalent to those of the predicate devices." This "substantial equivalence" is the basis for the FDA 510(k) clearance, indicating that the device is as safe and effective as legally marketed predicate devices. The document does not provide raw data, specific pass/fail values, or detailed performance metrics beyond stating substantial equivalence.

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General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory hand piece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.

The CONMED® Sabre Genesis™ and CONMED® HyfreSurg™OP Electrosurgical Generators are electrosurgical generators with the basic modes of operational electrosurgical cutting and coagulation. The devices consist of a single electrosurgical generator unit for each model to supply high frequency (HF) electrosurgical current to accessory hand pieces to produce the clinical effect. When cutting, the subject device provides the energy to the active electrode which is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the subject device provides the energy to the active electrode which may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result.

The subject devices (Sabre Genesis and HyfreSurg OP) are of the same construction in components and assembly. The difference is the HyfreSurg OP does not have the Pulse Cut functionality and the control panel is altered accordingly.

Use of these products for unintended applications could lead to an unsafe condition.

The device utilizes previously cleared/marketed and required accessories.

The provided text describes a 510(k) summary for the CONMED® Sabre Genesis™ and CONMED® HyfreSurg OPTM Electrosurgical Units. However, it does not include specific acceptance criteria for the device performance in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI/software devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device standards.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence cannot be fully answered from the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Not Applicable (N/A) from the Text:

• Quantitative Performance Metrics: The document does not provide specific numerical targets (e.g., accuracy > 90%, sensitivity > 85%) for clinical or analytical performance. This is typical for electrosurgical units, which are hardware devices, not AI/software.
• Study Design for "Proving Device Meets Acceptance Criteria": The document refers to "Performance Testing" and "Design verification and validation activities" but does not detail a specific clinical or analytical study designed to prove these criteria in a statistical sense, as would be expected for an AI/software device. Instead, it relies on adherence to established standards and comparison to predicate devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable/Not mentioned. The testing described is primarily focused on engineering and electrical safety standards for a hardware device, not a performance test on a specific dataset like an AI model.
• Data Provenance: Not applicable/Not mentioned. There is no "data" in the sense of patient records or images being used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. There is no ground truth establishment in the context of an AI/software device for an electrosurgical unit.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This document describes an electrosurgical unit (a hardware device), not an AI-assisted diagnostic or clinical support tool where human reader performance would be a relevant metric.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No. This is a hardware device; there is no "algorithm only" performance separate from the device's function.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. For this type of device, "ground truth" generally refers to adherence to engineering specifications and safety standards, as verified through physical testing, rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This is a manufactured hardware device, not an AI model that undergoes a "training" phase with a dataset.

9. How Ground Truth for Training Set Was Established

• How Ground Truth Was Established: Not applicable.

In summary: The provided 510(k) summary is for a traditional electrosurgical unit, not an AI/software device. Therefore, the concepts of "acceptance criteria," "study," "test set," "ground truth," "experts," and "training set" as they relate to AI/software performance evaluation are not applicable or described in this document. The device's "performance" is demonstrated through compliance with recognized medical device standards and substantial equivalence to previously cleared predicate devices, focusing on safety and basic functional effectiveness.

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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.

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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.

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The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.

The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.

Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the SABRe Compac Auditory Brainstem Response Screener, which primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the text is missing:

• A table of acceptance criteria and reported device performance: There are no specific performance metrics or thresholds mentioned for the device.
• Sample size used for the test set and data provenance: The document does not describe any specific test set or the characteristics of the data used for testing.
• Number of experts used to establish ground truth and their qualifications: This information is not present.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no indication of such a study being conducted or its results.
• Standalone (algorithm-only) performance: The device is described as an "evoked potential device" and "Screener" for use by "trained professionals," suggesting it's generally a diagnostic tool, but no standalone algorithmic performance is detailed.
• Type of ground truth used: Not specified.
• Sample size for the training set: Not mentioned as there's no description of an AI/ML algorithm being "trained" in the typical sense.
• How ground truth for the training set was established: Not applicable given the lack of training set information.

The core of the provided text is about the device's intended use and its substantial equivalence to a previously cleared device (SLE SABRE ABR Screener, K993177). This type of submission relies on demonstrating that the new device has similar technological characteristics and performs comparably to an already approved device, rather than presenting a full de novo study with detailed performance metrics against specific acceptance criteria.

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The SABRE Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the evaluation of hearing function.

The SABRE ABR Screener is an evoked potential device to be used in the evaluation of hearing function.

The provided 510(k) summary for the SABRE Auditory Brainstem Response Screener does not contain information regarding detailed acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, or comparative effectiveness with human readers. The document is primarily focused on establishing substantial equivalence to predicate devices based on intended use and technological characteristics.

Therefore, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample size used for the test set and data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
4. Adjudication method for the test set: Not available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not available.
6. Standalone (algorithm-only) performance: Not available.
7. Type of ground truth used: Not available.
8. Sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states that the SABRE ABR device is "similar in its intended use to predicate devices and existent methodologies," implying that its performance is expected to be comparable to these established devices, rather than being demonstrated through a detailed independent study described within this summary.

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The ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.

The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site.

Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.

The provided text describes a 510(k) premarket notification for a medical device, the ECI Sabre BT™ Blunt-Tip Surgical Trocar. It does not contain information about acceptance criteria, device performance, or a study report in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices, product description, indications for use, and biocompatibility testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only performance-related information provided is:

Biocompatibility:

• Cytotoxicity Test
• USP Intracutaneous Toxicity Test
• Guinea Pig Maximization (Kligman) Sensitization Test

Conclusion:
"Based on the indications for use, technological characteristics and performance testing, the ECI Sabre BT™ Blunt-Tip Surgical Trocar has been shown to be safe and effective for its intended use."

This conclusion is very general and does not provide specific acceptance criteria or quantitative performance metrics typically found in a study report for a diagnostic AI device.

It's important to note that this document is for a surgical trocar, which is a physical medical device, not an AI or software device. Therefore, the questions related to AI-specific metrics like "standalone algorithm performance," "MRMC comparative effectiveness study," "ground truth," "training set," and "test set" are not applicable to the information provided. The "performance testing" mentioned in the conclusion likely refers to mechanical, functional, and sterility testing typical for physical medical devices, which are not detailed in this summary.

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