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The indications statement for the New Device and the Predicate Devices is the same. All of the devices are used for approximating tissue and affixing prosthetic material. Both endoscopic and open procedures.

The GSI Fixation System and the predicate devices are endoscopic multi-fire, fastening systems. The New Device and the Predicate Devices are single patient use, disposable and supplied sterile, with the exception of the Origin Tacker System which is supplied in two parts: the fastener cartridge is single use, disposable and the handle is reusable.

I am sorry, but the provided text does not contain specific acceptance criteria or details about a study proving the device meets them. The document is a 510(k) summary for a "Fixation System," primarily focusing on its substantial equivalence to predicate devices and its intended use. It does not include information about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create a operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal), or subcutaneous extremity or thoracic space.

The indications for use include dissection of tissue for the following surgical procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery, including aesthetic surgery; vascular surgery for the exposure of superficial vessels of the upper and/or lower extremities (no deep structure would be targeted), including the saphenous vein and femoral vessels; thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall; procedures in the extraperitoneal space involving dissection of tissue layers allowing exposure of structures including: adrenals, bone, spine, lymph nodes, and kidneys.

Examples of specific surgical procedures the Spacemaker® Surgical Balloon Dissectors may be used to facilitate tissue dissection include: fascial lavers between the skin and peritoneum. hernia repair, varicocele dissection, sympathectomy, lymph node dissection, urethropexy, subfascial perforator vein ligation, access to the saphenous vein and femoral vessels, retroperitoneal access to the anterior spine, access for long bone plating.

The cannula portion of the device is intended to provide access for surgical and diagnostic instruments for the duration of the operative procedure.

The Spacemaker® Surgical Balloon Dissector devices are handheld, manually manipulated surgical balloon dissectors. The devices can be supplied with either a solid center rod or a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. The devices can be supplied with or without a cannula. The cannula provides access for operative and diagnostic instrumentation for the surgical procedure.

The provided 510(k) summary for K973046 does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/medical imaging device submissions.

This 510(k) submission is for the "Spacemaker® Surgical Balloon Dissector" and related devices. The basis for substantial equivalence is that the devices have the "same principle of operation as the predicate devices" and that "there are no changes to any of the Spacemaker® devices." Furthermore, the submission explicitly states:

"No functional bench testing was performed for this submission because no tests were necessary to substantiate the safety, performance or substantial equivalence."

Therefore, I cannot populate the requested table or answer most of the questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document. The device's clearance was based on its established substantial equivalence to predicate devices without new performance testing being deemed necessary.

However, I can provide the following based on the available information:

Summary based on K973046:

The K973046 submission for the Spacemaker® Surgical Balloon Dissector devices was granted clearance based on substantial equivalence to existing predicate devices, rather than through a performance study against specific acceptance criteria. The submission explicitly states that no functional bench testing was performed due to the lack of necessary substantiation for safety, performance, or substantial equivalence. Therefore, there are no reported acceptance criteria or a study proving the device meets acceptance criteria in the context of new performance testing.

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

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

• Not applicable. No test set was used for a performance study.

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

• Not applicable. No test set requiring expert-established ground truth was used.

4. Adjudication method for the test set:

• Not applicable. No test set was used.

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

• Not applicable. This device is a surgical instrument and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

• Not applicable. This device is a surgical instrument, not an algorithm. No standalone performance study was done.

7. The type of ground truth used:

• Not applicable. No performance study requiring ground truth was conducted. Substantial equivalence was based on device design and intended use matching predicate devices.

8. The sample size for the training set:

• Not applicable. This submission does not involve a machine learning model or a training set.

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

• Not applicable. No training set or associated ground truth was established for this submission.

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The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.

The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld, manually manipulated surgical balloon device which dissects tissue planes, intraoperatively and subsequently expands the overlying tissue. This device is a temporary subcutaneous or submuscular implant device. The Spacemaker® Surgical Balloon Dissector/Expander is a single use, disposable device provided sterile to the physician. The major components of the device are a balloon dissector and an injection port/connector.

This document is a 510(k) summary for the Spacemaker® Surgical Balloon Dissector/Expander, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner you're requesting for an AI/ML device.

Here's why and what information is provided:

This device is a Class I manually operated surgical instrument for general use, which was cleared in 1997. At that time, and for this type of device, the regulatory pathway (510(k)) primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria through extensive clinical studies as would be required for higher-risk or AI/ML devices today.

The document states:

• "Testing in Support of Substantial Equivalence: Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."

This indicates that some design-related tests were performed (likely mechanical or material tests according to ASTM standards), but these are not performance studies in the context of diagnostic accuracy, which is what your questions imply for AI/ML.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The clearance was based on substantial equivalence to existing devices.
2. Sample size used for the test set and the data provenance: Not applicable in the context of an "AI/ML" test set. The "tests" mentioned were likely engineering/device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device designed for diagnostic interpretation.
6. If a standalone performance study was done: "Specific ASTM tests" were done to evaluate design differences, but not a standalone clinical performance study as would be expected for an AI/ML diagnostic tool. The clearance is based on equivalence.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).

Summary of available relevant information from the document:

• Device Name: Spacemaker® Surgical Balloon Dissector/Expander
• Regulatory Pathway: 510(k) (Substantial Equivalence)
• Principle of Operation: Handheld, manually manipulated surgical balloon device which dissects tissue planes and expands overlying tissue.
• Tests Performed: "Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."
• Basis for Clearance: Substantial equivalence to predicate devices (K951878 Spacemaker® and Spacemaker® II, K904265 Inamed Ruiz-Cohen Intraoperative Expander, K862203 McGhan Magna-Site™ Tissue Expander, K843704 McGhan Tissue Expander).

The document is a regulatory clearance for a physical surgical tool from 1997, preceding the widespread use of AI/ML in medical devices and the associated regulatory requirements for performance metrics and studies.

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The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.

GSI's Cannula with Introducer is a hand held device comprised of a Cannula with an Introducer. The Cannula is comprised of a cannula body, an inflatable valve/seal and a stopcock. The inflatable valve/seal is inflated and deflated through the stopcock. The inflatable valve/seal provides a seal for surgical tools and diagnostic instruments during minimally invasive procedures using gas insufflation. The Cannula may be supplied with either a Sharp Tip or Blunt Tip Introducer. The Introducer is used for placement of the Cannula into an endoscopic or laparoscopic surgical space.

The provided text describes a 510(k) summary for a medical device (GSI Cannula with Introducer) and does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

The document discusses:

• Device Description: A hand-held device comprising a cannula with an introducer, designed for minimally invasive procedures.
• Intended Use: To provide access for surgical and diagnostic instruments during a surgical procedure, identical to the predicate device.
• Comparison to Predicate Device: A table comparing the GSI Cannula with an Introducer to the Hasson Stable Access Cannula (K903078) across various design and material aspects.
• Testing: Mentions "performance bench tests" were conducted to verify that differences from the predicate device do not affect safety or efficacy.

There is no mention of:

• Acceptance criteria related to performance metrics for AI/ML. The document is for a physical medical device, not an AI/ML powered one.
• Any study involving AI/ML performance.
• Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to AI/ML, nor the other requested details regarding an AI/ML study, as this information is not present in the provided text.

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The intended use of the Spacemaker® Serial Surgical Balloon Dissector is the same as the predicate devices (K944418, K951878). The intended use of the Spacemaker® Serial Surgical Balloon Dissector and the predicate devices is to dissect layers of connective tissue along natural planes of separation. The cannula portion of the device is intended to provide access for operative and diagnostic instruments for the duration of the operative procedure.

Indications: Any area of the body where it is necessary to separate the layers of connective tissue for surgical access.

Examples where surgical dissection of natural tissue planes can provide surgical access: General, laparoscopic, endoscopic, plastic and reconstructive, including aesthetic surgery and vascular use for the exposure of superficial veins of the upper and/or lower extremities; no arterial nor deep nor non-extremity structure would be targeted.

The Spacemaker® Serial Surgical Balloon Dissector device is a disposable, handheld, manually manipulated surgical balloon dissection device consists of a balloon, center rod, handle, and suction/fill assembly. The device can be supplied either with a solid center rod or with a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. Both versions can be inflated and deflated multiple times during a procedure.

The device can be supplied with or without a cannula. The cannula provides access for operative and diagnostic instrumentation for the duration of the surgical procedure.

This submission seeks clearance for the Spacemaker® Serial Surgical Balloon Dissector to be supplied in four configurations as follows:

Spacemaker® Serial Surgical Balloon Dissector, Class II
Spacemaker® Serial Surgical Balloon Dissector with Cannula, Class II
Spacemaker® Serial Surgical Balloon Dissector with Visualization, Class II
Spacemaker® Serial Surgical Balloon Dissector with Visualization and Cannula, Class II

This document describes the Spacemaker® Serial Surgical Balloon Dissector, a manual surgical device, and its comparison to predicate devices for its 510(k) submission.

Based on the provided text, the device itself is a physical surgical tool and not an AI/ML powered device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable. The information focuses on bench testing for safety and efficacy in relation to material and function changes.

Here's a breakdown of the available information:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics of the device itself (e.g., dissection time, precision of dissection). Instead, the performance verification is centered around demonstrating that modifications do not affect the safety or efficacy compared to predicate devices. The key "performance" aspect highlighted is the ability for multiple balloon inflations per procedure (a new feature) and the biocompatibility of new materials.

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

The document mentions "performance bench tests." It does not specify the sample size for these bench tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective).

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 section is not applicable as the device is a manual surgical tool and the tests described are bench tests, not clinical evaluations requiring expert ground truth for interpretation of outcomes.

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

This is not applicable as there is no human interpretation or adjudication described for the bench tests.

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 is not applicable as the device is not an AI/ML powered tool and therefore no MRMC study would be relevant.

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

This is not applicable as the device is a manual surgical tool, not an algorithm.

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

For the biocompatibility testing, the "ground truth" is defined by the ANSI/AAMI 10993-1 (ISO 10993-1) standard. For the overall safety and efficacy, the "ground truth" is the performance of the predicate devices. The testing aims to show non-inferiority based on bench test results.

8. The sample size for the training set

This is not applicable as the device is a manual surgical tool and does not employ AI/ML that would require a training set.

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

This is not applicable for the same reasons as point 8.

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The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

The GSI Mammary Sizer is designed to be used during plastic and reconstructive surgery when it is desirable to determine the correct volume and/or symmetry of mammary implants prior to implantation. The device is constructed of smooth semi-elastomeric polyurethane. The device consists of a balloon and balloon tubing used for filling the sizer. There is an attachment to prevent fluid leakage and a female luer lock at the proximal end of the filler tube.

The provided text describes the "Mammary Sizer" device and mentions "Testing Results and Conclusions" that include "biocompatibility, material strength, and volume rating." However, it does not provide specific acceptance criteria or details of a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for the following information 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
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document is a 510(k) summary, which typically provides a high-level overview. Detailed testing protocols and results, including specific acceptance criteria and study designs, are usually found in the full 510(k) submission, which is not provided here. The summary states that the device is "substantially equivalent" to a predicate device, and the testing mentioned (biocompatibility, material strength, volume rating) likely supports this claim of substantial equivalence for safety and effectiveness, but the specifics of how these were tested against defined criteria are missing.

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